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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT03874884
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{'Official Title': '177Lu-PSMA-617 Therapy and Olaparib in Patients With Metastatic Castration Resistant Prostate Cancer', 'Brief Summary': 'This phase 1 dose-escalation and dose-expansion study is designed to evaluate the safety and tolerability of olaparib in combination with 177Lutetium-Prostate Specific Membrane Antigen (177 Lu-PSMA) in patients with metastatic castration resistant prostate cancer (mCRPC).', 'Condition': 'Metastatic Castration Resistant Prostate Cancer', 'Detailed Description': 'This phase 1, open label, multicentre, dose-escalation and dose-expansion study is designed to evaluate the safety and tolerability of olaparib in combination with 177Lu-PSMA in patients with mCRPC. Patients with mCRPC who have previously progressed on a novel AR targeted agent (abiraterone and/or enzalutamide and/or apalutamide) and have not had prior exposure to platinums, PARP inhibitors or 177Lu-PSMA will be eligible for the study. Patients can have had prior exposure to docetaxel in the chemotherapy naïve setting or castrate setting.\r\n\r\nPatients will be enrolled in two stages: a dose escalation and a dose expansion phase. The clinical and translational outcomes from this study will inform the design of future phase 2/3 clinical trials of this combination.\r\n\r\nThis is a single arm study where patients will receive 177Lu-PSMA and olaparib for upto 4 cycles.', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nPatients must meet all of the following criteria for study entry:\r\n\r\nPatient must be ≥ 18 years of age and must have provided written informed consent.\r\nHistologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell differentiation.\r\nEastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 (see Appendix 1).\r\nPatients must have had at least one prior line of taxane (docetaxel) chemotherapy either in the hormone sensitive or castrate resistant setting unless the patient is deemed medically unsuitable for chemotherapy. If a patient has had docetaxel chemotherapy twice, this will be considered one line.\r\nPatients must have progressed on a second generation AR targeted agent (e.g. enzalutamide, abiraterone and/or apalutamide). Determination of disease progression on second generation AR targeted agent will be made by the local investigator.\r\nPatients must have progressive disease for study entry. This is defined by PCWG3 as any one of the following:\r\n\r\nPSA progression: minimum of two rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement. The PSA value at screening should be ≥ 10ng/ml.\r\nSoft tissue or visceral disease progression as per RECIST 1.1 criteria (see Appendix 2)\r\nBone progression: ≥ 2 new lesions on bone scan (Appendix 2)\r\nAt least 3 weeks since the completion of surgery or radiotherapy prior to registration. Any clinically relevant sequelae from the surgery or radiotherapy must have improved to grade 1 prior to registration.\r\nPrior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist). Patients without prior surgical castration must be currently taking and willing to continue luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) therapy throughout the duration of study treatment.\r\nSerum testosterone levels ≤ 50ng/dL (≤ 1.75nmol/L) within 28 days before registration.\r\nImaging evidence of metastatic disease documented with either bone scan or CT scan (Appendix 2).\r\nPrior prostate cancer vaccine therapy, radiation therapy, systemic therapies, diethylstilboestrol (DES) or other estrogens, bicalutamide, flutamide or nilutamide are allowed up to 28 days prior to trial registration. Note: bicalutamide, flutamide or nilutamide must be discontinued within 4 weeks of registration.\r\nSignificant PSMA avidity on 68Ga/18F-PSMA PET/CT, defined as a minimum uptake of SUVmax 15 at a site of disease, and SUVmax > 10 at other sites of disease ≥10mm (unless subject to factors explaining a lower uptake, e.g. respiratory motion, reconstruction artefact).\r\nPatients must have a life expectancy ≥ 24 weeks.\r\nPatients must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception (see section 11.7.4 for acceptable methods).\r\nPatients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled assessments including completing Patient Reported Outcomes (PRO) instruments.\r\nPatients must have adequate bone marrow, hepatic and renal function documented within 28 days prior to registration, defined as:\r\n\r\nHaemoglobin ≥ 100 g/L independent of transfusions (no red blood cell transfusion in last 8 weeks)\r\nAbsolute neutrophil count ≥ 1.5x109/L\r\nPlatelets ≥ 150 x109/L\r\nTotal bilirubin ≤ 1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome where this applies for the unconjugated bilirubin.\r\nAspartate transaminase (AST) (SGOT) and alanine transaminase (ALT) (SGPT) ≤ 2.5 x ULN if there is no evidence of liver metastasis or ≤ 5 x ULN in the presence of liver metastases.\r\nAlbumin ≥ 30 g/L\r\nAdequate renal function: patients must have creatinine clearance estimated of ≥ 51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test to appendix 5).\r\nPatients who are deemed by PSMA imaging to have readily accessible disease will be required to consent to 3 serial tumour biopsies - at screening, post combination treatment (at any time between weeks 2-4) and in the event of disease progression."}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03635567
|
{'Official Title': 'A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.\nThe primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nHas persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation)\nNot pregnant or breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP), b.) A WOCBP must agree to use effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab/placebo and 210 days after the last dose of chemotherapy/bevacizumab\nHas measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization\nHas adequate organ function'}
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{'Arm - Disease - Stage of Cancer': 'Stage IV'}
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|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03635567
|
{'Official Title': 'A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.\nThe primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nHas persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation)\nNot pregnant or breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP), b.) A WOCBP must agree to use effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab/placebo and 210 days after the last dose of chemotherapy/bevacizumab\nHas measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization\nHas adequate organ function'}
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{'Arm - Disease - Stage of Cancer': 'Stage IV'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03907488
|
{'Official Title': 'A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma', 'Brief Summary': "This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.", 'Condition': 'Ann Arbor Stage III Hodgkin Lymphoma\nAnn Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma\nAnn Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma\nAnn Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Hodgkin Lymphoma\nAnn Arbor Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Mixed Cellularity Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma\nClassic Hodgkin Lymphoma\nLymphocyte-Rich Classic Hodgkin Lymphoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\nI. To compare the progression-free survival (PFS) in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD (nivolumab, doxorubicin hydrochloride [doxorubicin], vinblastine sulfate [vinblastine], dacarbazine) versus that obtained with BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine).\nSECONDARY OBJECTIVES:\nI. To compare overall survival (OS) in patients randomized to N-AVD versus BV-AVD.\nII. To compare event-free survival (EFS) in patients randomized to N-AVD versus BV-AVD.\nIII. To compare the metabolic complete response (CR) rate at the end of treatment in patients randomized to N-AVD versus BV-AVD.\nIV. To compare the physician-reported treatment-related adverse event rates between arms stratified by age groups.\nV. To compare patient-reported symptoms using selected Patient Reported Outcome Common Toxicity Criteria for Adverse Events (PRO-CTCAE) items between arms stratified by age groups.\nVI. To compare the safety and tolerability of N-AVD versus that of BV-AVD.\nQUALITY OF LIFE OBJECTIVE:\nI. To compare between arms patient-reported fatigue, neuropathy and health-related quality of life over time (baseline, beginning of cycle 3, 4-8 weeks after the last dose of protocol therapy [following last dose of study drug or radiation therapy, whichever is later], and 1 and 3 years after randomization) using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx), and the PROMIS Global, respectively.\nBANKING OBJECTIVES:\nI. To bank specimens for future correlative studies. II. To bank positron emission tomography (PET)-computed tomography (CT) images for future correlative studies.\nOUTLINE: Patients are randomized to 1 of 2 arms.\nARM I: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim subcutaneously (SC) on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and/or magnetic resonance imaging (MRI) on study.\nARM II: Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.\nAfter completion of study treatment and prior to disease progression, patients are followed up every 3 months for the first year, every 6 months for years 2 and 3, then annually until 10 years after registration. Patients are followed up at the time of progression and then annually until 10 years after registration. Patients who receive radiation therapy are followed up at 8-12 weeks after completion of radiation therapy.', 'Inclusion Criteria': 'Inclusion Criteria:\nAll patients must have histologically confirmed newly diagnosed, previously untreated stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified [NOS]). Nodular lymphocyte predominant Hodgkin lymphoma is not eligible.\nPatients must have bidimensionally measurable disease (at least one lesion with longest diameter >= 1.5 cm) documented on the Lymphoma Baseline Tumor Assessment Form in Rave.\nPatients must have a whole body or limited whole body PET-CT scan performed within 42 days prior to registration. (A contrast-enhanced [diagnostic] CT, MRI or MR-PET is acceptable in event that PET-CT is contra-indicated, however if it is later possible to administer a PET-CT, then PET-CT is strongly preferred for the interim scan (after cycle 2) (if performed) and the EOT assessment. Otherwise, if PET-CT is not subsequently possible, then the same modality as baseline must be used throughout the trial.) NOTE: All images from PET-CT, CT, MRI or MR-PET scans performed as standard of care to assess disease (within 42 days prior to registration) must be submitted and associated radiology reports must be submitted.\nPatients must be >= 12 years of age.\nPatients must not have received any prior chemotherapy, radiation, or antibody-based treatment for classical Hodgkin lymphoma. Steroid pre-treatment is permitted.\nPatients must not have had prior solid organ transplant.\nPatients must not have had prior allogeneic stem cell transplantation.\nPatients must not have received a live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guerin [BCG], oral polio vaccine, and oral typhoid).\nAt registration, investigator must declare intent-to-treat with residual PET radiation therapy (residual PET RT- RPRT) to be administered after patient completes 6 cycles of therapy if, after end of treatment, the patient meets criteria specified for receiving RT). Patients will be stratified by investigator\'s intent-to-treat with residual PET RT.\nAll pediatric patients (< 18 years of age) will be considered intent-to-treat with Residual PET RT at time of registration.\nPatients must have a performance status corresponding to Zubrod scores of 0, 1 or 2. Use Lansky for patients =< 17 years of age. *The conversion of the Lansky to Eastern Cooperative Oncology Group (ECOG) scales is intended for National Cancer Institute (NCI) reporting purposes only.\nAdults (age 18 or older): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight.\nPediatric Patients (age 12-17), the following must have been obtained within 14 days prior to registration:\nMeasured or calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2, or\nSerum creatinine =< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine (SCr) based on age/gender as follows:\nAge < 13 maximum serum creatinine: Male 1.2 mg/dL; Female 1.2 mg/dL\nAge 13 to < 16 maximum serum creatinine: Male 1.5 mg/dL; Female 1.4 mg/dL\nAge 16-17 maximum serum creatinine: Male 1.7 mg/dL; Female 1.4 mg/dL\nTotal bilirubin =< 2 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).\nUnless due to Gilbert\'s disease, lymphomatous involvement of liver or vanishing bile duct syndrome\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).\nUnless due to Gilbert\'s disease, lymphomatous involvement of liver or vanishing bile duct syndrome\nPatients must have an echocardiogram (ECHO), multigated acquisition (MUGA), or functional cardiac imaging scan with a left ventricular ejection (LVEF) fraction >= 50% or a shortening fraction of >= 27%. For all patients, the ECHO, MUGA, or functional cardiac imaging scan must be performed within 42 days prior to registration.\nPatients with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable or unquantifiable viral load at their most recent viral load test within 6 months prior to registration.\nPatients must not have known active hepatitis B (HBV) or hepatitis C virus (HCV) at date of registration. Patients with previously treated HBV or HCV that have an undetectable viral load within 6 months prior to registration and no residual hepatic impairment are eligible.\nPatients must not have any known central nervous system lymphoma.\nPatients must not have a history of or active interstitial pneumonitis or interstitial lung disease.\nPatients must not have had a diagnosis of inherited or acquired immunodeficiency.\nPatients must not have any known uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, hemodynamically unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\nPatients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued prior to cycle 1, day 1.\nPatients with peripheral neuropathy must have < grade 2 at date of registration.\nPatients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with doses higher than prednisone 10 mg or equivalent). Autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease (including ulcerative colitis and Crohn\'s disease), as well as symptomatic disease (e.g.: rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener\'s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis or glomerulonephritis). Vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years are permitted.\nNo second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, any in situ cancer or other cancer for which the patient has been disease free for two years.\nFemales of childbearing potential must not be pregnant or nursing, and have a negative pregnancy test within 28 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method while receiving study drug and for women until 6 months after receiving the last dose of study drug or, for men, until 7 months after receiving the last dose of study drug. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.\nPatients must have one formalin-fixed paraffin embedded (FFPE) diagnostic tumor block or at least 1 diagnostic, 4-5 micron, hematoxylin and eosin (H&E) slide collected prior to registration and available for submission.\nPatients must be offered participation in banking for planned translational medicine and future research. With patient consent, any residuals from the mandatory tissue submission will also be banked for future research.\nPatients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must complete the PROMIS Fatigue, the FACT/GOG-Ntx, and the PROMIS Global prior to registration.\nPatients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must also agree to complete the PROMIS Fatigue, the FACT/GOG-Ntx, the PROMIS Global, and the PRO-CTCAE (or Pediatric [Ped] PRO-CTCAE) at the scheduled on-study assessment timepoints.\nPatients must be informed of the investigational nature of this study and all patients and/or their parents or legal guardians (for patients < 18 years of age) must sign and give informed consent and assent (where appropriate) in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board Initiative (CIRB) regulations.'}
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{'Arm - Disease - Stage of Cancer': 'Newly Diagnosed, Stage III, Stage IV, Advanced'}
| 0
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03907488
|
{'Official Title': 'A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma', 'Brief Summary': "This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.", 'Condition': 'Ann Arbor Stage III Hodgkin Lymphoma\nAnn Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma\nAnn Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma\nAnn Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Hodgkin Lymphoma\nAnn Arbor Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Mixed Cellularity Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma\nClassic Hodgkin Lymphoma\nLymphocyte-Rich Classic Hodgkin Lymphoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\nI. To compare the progression-free survival (PFS) in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD (nivolumab, doxorubicin hydrochloride [doxorubicin], vinblastine sulfate [vinblastine], dacarbazine) versus that obtained with BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine).\nSECONDARY OBJECTIVES:\nI. To compare overall survival (OS) in patients randomized to N-AVD versus BV-AVD.\nII. To compare event-free survival (EFS) in patients randomized to N-AVD versus BV-AVD.\nIII. To compare the metabolic complete response (CR) rate at the end of treatment in patients randomized to N-AVD versus BV-AVD.\nIV. To compare the physician-reported treatment-related adverse event rates between arms stratified by age groups.\nV. To compare patient-reported symptoms using selected Patient Reported Outcome Common Toxicity Criteria for Adverse Events (PRO-CTCAE) items between arms stratified by age groups.\nVI. To compare the safety and tolerability of N-AVD versus that of BV-AVD.\nQUALITY OF LIFE OBJECTIVE:\nI. To compare between arms patient-reported fatigue, neuropathy and health-related quality of life over time (baseline, beginning of cycle 3, 4-8 weeks after the last dose of protocol therapy [following last dose of study drug or radiation therapy, whichever is later], and 1 and 3 years after randomization) using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx), and the PROMIS Global, respectively.\nBANKING OBJECTIVES:\nI. To bank specimens for future correlative studies. II. To bank positron emission tomography (PET)-computed tomography (CT) images for future correlative studies.\nOUTLINE: Patients are randomized to 1 of 2 arms.\nARM I: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim subcutaneously (SC) on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and/or magnetic resonance imaging (MRI) on study.\nARM II: Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.\nAfter completion of study treatment and prior to disease progression, patients are followed up every 3 months for the first year, every 6 months for years 2 and 3, then annually until 10 years after registration. Patients are followed up at the time of progression and then annually until 10 years after registration. Patients who receive radiation therapy are followed up at 8-12 weeks after completion of radiation therapy.', 'Inclusion Criteria': 'Inclusion Criteria:\nAll patients must have histologically confirmed newly diagnosed, previously untreated stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified [NOS]). Nodular lymphocyte predominant Hodgkin lymphoma is not eligible.\nPatients must have bidimensionally measurable disease (at least one lesion with longest diameter >= 1.5 cm) documented on the Lymphoma Baseline Tumor Assessment Form in Rave.\nPatients must have a whole body or limited whole body PET-CT scan performed within 42 days prior to registration. (A contrast-enhanced [diagnostic] CT, MRI or MR-PET is acceptable in event that PET-CT is contra-indicated, however if it is later possible to administer a PET-CT, then PET-CT is strongly preferred for the interim scan (after cycle 2) (if performed) and the EOT assessment. Otherwise, if PET-CT is not subsequently possible, then the same modality as baseline must be used throughout the trial.) NOTE: All images from PET-CT, CT, MRI or MR-PET scans performed as standard of care to assess disease (within 42 days prior to registration) must be submitted and associated radiology reports must be submitted.\nPatients must be >= 12 years of age.\nPatients must not have received any prior chemotherapy, radiation, or antibody-based treatment for classical Hodgkin lymphoma. Steroid pre-treatment is permitted.\nPatients must not have had prior solid organ transplant.\nPatients must not have had prior allogeneic stem cell transplantation.\nPatients must not have received a live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guerin [BCG], oral polio vaccine, and oral typhoid).\nAt registration, investigator must declare intent-to-treat with residual PET radiation therapy (residual PET RT- RPRT) to be administered after patient completes 6 cycles of therapy if, after end of treatment, the patient meets criteria specified for receiving RT). Patients will be stratified by investigator\'s intent-to-treat with residual PET RT.\nAll pediatric patients (< 18 years of age) will be considered intent-to-treat with Residual PET RT at time of registration.\nPatients must have a performance status corresponding to Zubrod scores of 0, 1 or 2. Use Lansky for patients =< 17 years of age. *The conversion of the Lansky to Eastern Cooperative Oncology Group (ECOG) scales is intended for National Cancer Institute (NCI) reporting purposes only.\nAdults (age 18 or older): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight.\nPediatric Patients (age 12-17), the following must have been obtained within 14 days prior to registration:\nMeasured or calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2, or\nSerum creatinine =< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine (SCr) based on age/gender as follows:\nAge < 13 maximum serum creatinine: Male 1.2 mg/dL; Female 1.2 mg/dL\nAge 13 to < 16 maximum serum creatinine: Male 1.5 mg/dL; Female 1.4 mg/dL\nAge 16-17 maximum serum creatinine: Male 1.7 mg/dL; Female 1.4 mg/dL\nTotal bilirubin =< 2 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).\nUnless due to Gilbert\'s disease, lymphomatous involvement of liver or vanishing bile duct syndrome\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).\nUnless due to Gilbert\'s disease, lymphomatous involvement of liver or vanishing bile duct syndrome\nPatients must have an echocardiogram (ECHO), multigated acquisition (MUGA), or functional cardiac imaging scan with a left ventricular ejection (LVEF) fraction >= 50% or a shortening fraction of >= 27%. For all patients, the ECHO, MUGA, or functional cardiac imaging scan must be performed within 42 days prior to registration.\nPatients with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable or unquantifiable viral load at their most recent viral load test within 6 months prior to registration.\nPatients must not have known active hepatitis B (HBV) or hepatitis C virus (HCV) at date of registration. Patients with previously treated HBV or HCV that have an undetectable viral load within 6 months prior to registration and no residual hepatic impairment are eligible.\nPatients must not have any known central nervous system lymphoma.\nPatients must not have a history of or active interstitial pneumonitis or interstitial lung disease.\nPatients must not have had a diagnosis of inherited or acquired immunodeficiency.\nPatients must not have any known uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, hemodynamically unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\nPatients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued prior to cycle 1, day 1.\nPatients with peripheral neuropathy must have < grade 2 at date of registration.\nPatients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with doses higher than prednisone 10 mg or equivalent). Autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease (including ulcerative colitis and Crohn\'s disease), as well as symptomatic disease (e.g.: rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener\'s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis or glomerulonephritis). Vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years are permitted.\nNo second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, any in situ cancer or other cancer for which the patient has been disease free for two years.\nFemales of childbearing potential must not be pregnant or nursing, and have a negative pregnancy test within 28 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method while receiving study drug and for women until 6 months after receiving the last dose of study drug or, for men, until 7 months after receiving the last dose of study drug. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.\nPatients must have one formalin-fixed paraffin embedded (FFPE) diagnostic tumor block or at least 1 diagnostic, 4-5 micron, hematoxylin and eosin (H&E) slide collected prior to registration and available for submission.\nPatients must be offered participation in banking for planned translational medicine and future research. With patient consent, any residuals from the mandatory tissue submission will also be banked for future research.\nPatients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must complete the PROMIS Fatigue, the FACT/GOG-Ntx, and the PROMIS Global prior to registration.\nPatients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must also agree to complete the PROMIS Fatigue, the FACT/GOG-Ntx, the PROMIS Global, and the PRO-CTCAE (or Pediatric [Ped] PRO-CTCAE) at the scheduled on-study assessment timepoints.\nPatients must be informed of the investigational nature of this study and all patients and/or their parents or legal guardians (for patients < 18 years of age) must sign and give informed consent and assent (where appropriate) in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board Initiative (CIRB) regulations.'}
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{'Arm - Disease - Stage of Cancer': 'Newly Diagnosed, Stage III, Stage IV, Advanced'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT03936270
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{'Official Title': 'Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer.', 'Brief Summary': 'The primary objective of this study is to evaluate 12 weeks progression-free survival (PFS) rate of Palbociclib plus Letrozole in ER/PR positive endometrioid or high-grade serous ovarian cancer who have disease progression on second-line chemotherapy.', 'Condition': 'Ovarian Cancer', 'Detailed Description': 'Letrozole (Femara®) is an oral non-steroidal aromatase inhibitor that is approved worldwide for the treatment of postmenopausal women with breast cancer. It is administered orally on a continuous 2.5 mg daily dosing regimen and has a good toxicity profile. Palbociclib (Ibrance®) is an active potent and highly selective reversible inhibitor of cyclin- dependent kinases 4 and 6 (CDK4/6). Palbociclib was approved by the United States Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor based on a randomized, double-blind, placebo-controlled, international clinical trial PALOMA-2. It is administered orally on a dose of 125 mg per day in 4-week cycles (3 weeks of treatment followed by 1 week off). This trial was based on preclinical studies that showed a synergistic effect between targeting the ER and cyclin-D-CDK4/6-Rb pathway. The principal toxicity was myelotoxicity but it was managed with appropriate supportive care and dose reductions13.\n\nBased on the results of phase 1 and 2 clinical trials of CDK4/6 inhibitors used as monotherapy to treat patients with recurrent ovarian cancer, we hypothesized that, as Palbociclibe is active in this population and many ovarian cancer show ER/PR expression, its combination with Letrozole can improve outcomes in ER/PR positive endometrioid or high-grade serous Ovarian Cancer who have disease progression on second-line chemotherapy, similar to what is seen in breast cancer studies.', 'Inclusion Criteria': "Inclusion Criteria:\n\nEvidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;\nSubject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;\n18 years of age or older;\nPatient agrees not to participate in another interventional study while on treatment;\nHistology confirmed ovarian cancer serous or endometrioid high degree, fallopian tube or with locoregional recurrence peritoneum (not amenable to curative treatment) or metastatic;\nEstrogen (ER) and/or progesterone (RP) receptor positive tumor, defined as > 10% by immunohistochemical examination in the local laboratory;\nAvailability of tumor sample from the primary tumor or metastasis, fixed in formalin and embedded in paraffin, for confirmation of positivity for ER and/or RP in a central laboratory;\nDisease measurable by RECIST 1.1 as assessed by the local investigator or radiologist;\nPatients must have chemotherapy application for recurrence locoregional or metastatic according to the following criteria:\n\nat least one platinum-based chemotherapy regimen;\nhave confirmed no more than 3 chemotherapy regimens for locally advanced or metastatic disease\nPatient must have radiographic disease progression to last treatment;\nFunctional capacity by the Eastern Cooperative Oncology Group (ECOG) ≤ 2;\nAdequate bone marrow function:\n\nAbsolute neutrophil count (CAN) ≥ 1,500/mm3 (≥ 1.5x109/L)\nPlates ≥ 100,000/mm3 or ≥ 100 x 109/L\nHemoglobin ≥ 9.0 g/dL;\n12. Adequate liver function:\n\nTotal serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (≤ 3.0 x ULN if there is Gilbert's Syndrome)\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN (≤ 5.0 x ULN if liver tumor was involved)\nAlkaline phosphatase ≤ 2.5 x ULN (≤ 5.0 x ULN if any liver tumor involvement); 13. Adequate kidney function:\nEstimated creatinine clearance ≥ 15 mL/min; 14. Evidence of lack of potential to become pregnant:\nPost-menopause (defined as at least 1 year without menstruation) before selection, or\nRadiotherapy-induced oophorectomy with the last menstruation > 1 year ago, or\nSurgical sterilization (bilateral oophorectomy or hysterectomy)."}
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{'Arm - Disease - Stage of Cancer': 'High-Grade, Metastatic, Locoregional, Locally Advanced'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT03627728
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{'Official Title': 'Phase II Randomized Study of Maintenance Regorafenib vs Placebo in no Progression Patients After First-line Platinum and Fluoropyrimidines Based Chemotherapy in HER2 Negative Locally Advanced/Metastatic Gastric or Gastroesophagel Junction Cancer (a-MANTRA Study)', 'Brief Summary': 'Randomized, double-blind, placebo-controlled, multicenter Phase-II study.\r\n\r\nApproximately 120 subjects with CR/PR/SD after platinum compounds and fluoropyrimidines based regimens: up to 6 cycles of cisplatin and 5-fluorouracil or capecitabine, up to 12 cycles of FOLFOX, up to 8 cycles of XELOX, will be randomly assigned (1:1 ratio) to one of the following treatment groups:\r\n\r\nArm A: Placebo 4 tablets once daily on day 1-21, every 4 weeks, until intolerance or progression disease Arm B: Regorafenib 160 mg, 4 tablets once daily on days 1-21, every 4 weeks, until intolerance or progression disease Primary Variable: PFS1', 'Condition': 'Gastric Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale of female ≥ 18 years of age\r\nHave an Eastern Cooperative Oncology Group performance status of 0 or 1 within 14 days prior to the initiation of study treatment\r\nDiagnosis of histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction\r\nHER2 negative gastric or gastroesophagel junction cancer ( ICH 0, IHC 1+, IHC + FISH -)\r\nLocally advanced/metastatic gastric or gastroesophageal junction cancer\r\nCR/PR/SD after first-line platinum compound and Fluoropyrimidines based chemotherapy\r\nMeasurable disease according to RECIST 1.1 criteria\r\nHave adequate bone marrow function, liver function, and renal function, as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment:\r\nTotal bilirubin 1.5 times the upper limit of normal (ULN)\r\nAlanine aminotransferase and aspartate aminotransferase 3 times the ULN\r\nLipase 1.5 times the ULN\r\nSerum creatinine 1.5 times the ULN\r\nGlomerular filtration rate 30 mL/min/1,73 m2 according to the Modified Diet in Renal Disease abbreviated formula\r\nInternational normalized ratio of prothrombin time and activated partial thromboplastin time 1.5 times the ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history.\r\nPlatelet count 100,000 /mm3, hemoglobin 9 g/dL, absolute neutrophil count 1500/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors\r\nAlkaline phosphatase ≤ 2.5 times the ULN\r\nUnderstand, be willing to give consent, and sign the written informed consent form (ICF) prior to undergoing any study-specific procedure.\r\nIf female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment.\r\nIf female and of childbearing potential, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF is signed until 8 weeks after the last dose of study drug.'}
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{'Arm - Disease - Stage of Cancer': 'Locally advanced, Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT03627728
|
{'Official Title': 'Phase II Randomized Study of Maintenance Regorafenib vs Placebo in no Progression Patients After First-line Platinum and Fluoropyrimidines Based Chemotherapy in HER2 Negative Locally Advanced/Metastatic Gastric or Gastroesophagel Junction Cancer (a-MANTRA Study)', 'Brief Summary': 'Randomized, double-blind, placebo-controlled, multicenter Phase-II study.\r\n\r\nApproximately 120 subjects with CR/PR/SD after platinum compounds and fluoropyrimidines based regimens: up to 6 cycles of cisplatin and 5-fluorouracil or capecitabine, up to 12 cycles of FOLFOX, up to 8 cycles of XELOX, will be randomly assigned (1:1 ratio) to one of the following treatment groups:\r\n\r\nArm A: Placebo 4 tablets once daily on day 1-21, every 4 weeks, until intolerance or progression disease Arm B: Regorafenib 160 mg, 4 tablets once daily on days 1-21, every 4 weeks, until intolerance or progression disease Primary Variable: PFS1', 'Condition': 'Gastric Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale of female ≥ 18 years of age\r\nHave an Eastern Cooperative Oncology Group performance status of 0 or 1 within 14 days prior to the initiation of study treatment\r\nDiagnosis of histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction\r\nHER2 negative gastric or gastroesophagel junction cancer ( ICH 0, IHC 1+, IHC + FISH -)\r\nLocally advanced/metastatic gastric or gastroesophageal junction cancer\r\nCR/PR/SD after first-line platinum compound and Fluoropyrimidines based chemotherapy\r\nMeasurable disease according to RECIST 1.1 criteria\r\nHave adequate bone marrow function, liver function, and renal function, as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment:\r\nTotal bilirubin 1.5 times the upper limit of normal (ULN)\r\nAlanine aminotransferase and aspartate aminotransferase 3 times the ULN\r\nLipase 1.5 times the ULN\r\nSerum creatinine 1.5 times the ULN\r\nGlomerular filtration rate 30 mL/min/1,73 m2 according to the Modified Diet in Renal Disease abbreviated formula\r\nInternational normalized ratio of prothrombin time and activated partial thromboplastin time 1.5 times the ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history.\r\nPlatelet count 100,000 /mm3, hemoglobin 9 g/dL, absolute neutrophil count 1500/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors\r\nAlkaline phosphatase ≤ 2.5 times the ULN\r\nUnderstand, be willing to give consent, and sign the written informed consent form (ICF) prior to undergoing any study-specific procedure.\r\nIf female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment.\r\nIf female and of childbearing potential, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF is signed until 8 weeks after the last dose of study drug.'}
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{'Arm - Disease - Stage of Cancer': 'Locally advanced, Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT04590599
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{'Official Title': 'A Randomized, Double-blind, Controlled, Parallel-cohort Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy', 'Brief Summary': 'This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based chemotherapy', 'Condition': 'Advanced Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nThe subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol.\r\nAged ≥18 years and ≤75 years.\r\nDiagnosed with cervical cancer by histology/cytology.\r\nPatients with relapsed or metastatic cervical cancer who have had progressed or relapsed after receiving at least first-line of platinum-based chemotherapy (if a patient has progressed or relapsed during or within 6 months after receiving platinum-based neoadjuvant or adjuvant chemotherapy, she will be deemed to have received first-line treatment).\r\nThe subject's previous systemic treatment must have ended ≥4 weeks before the first study administration, and the treatment-related AEs have recovered to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 grade ≤1 (except for alopecia and fatigue)."}
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{'Arm - Disease - Stage of Cancer': 'Advanced, Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT04590599
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{'Official Title': 'A Randomized, Double-blind, Controlled, Parallel-cohort Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy', 'Brief Summary': 'This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based chemotherapy', 'Condition': 'Advanced Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nThe subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol.\r\nAged ≥18 years and ≤75 years.\r\nDiagnosed with cervical cancer by histology/cytology.\r\nPatients with relapsed or metastatic cervical cancer who have had progressed or relapsed after receiving at least first-line of platinum-based chemotherapy (if a patient has progressed or relapsed during or within 6 months after receiving platinum-based neoadjuvant or adjuvant chemotherapy, she will be deemed to have received first-line treatment).\r\nThe subject's previous systemic treatment must have ended ≥4 weeks before the first study administration, and the treatment-related AEs have recovered to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 grade ≤1 (except for alopecia and fatigue)."}
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{'Arm - Disease - Stage of Cancer': 'Advanced, Metastatic'}
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|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05608785
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{'Official Title': 'Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes', 'Brief Summary': 'Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective: To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced/advanced gastric or combined gastroesophageal adenocarcinoma with different gene/protein types.\r\n\r\nEvaluation criteria: To evaluate the adverse effects of drugs using the NCI CTCAE V5.0 criteria.\r\n\r\nRECIST1.1 criteria were used to evaluate drug efficacy Study endpoints: Primary indicators Objective Response Rate (ORR) Secondary indicators 1. drug safety. 2. disease control rate DCR (CR+PR+SD). 3. duration of remission DoR. 4. disease-free survival (PFS) and overall survival time (OS). 5. R0/R1 surgical resection rate Study design: Single-center umbrella clinical trial Planned number of enrollment: Total 39-45 cases Sample size estimation: This is an exploratory study and sample size was not calculated Statistical methods: Selection of data for statistical analysis Full Analysis Set (FAS): The efficacy analysis was performed on all patients who were enrolled and used the drug at least once, according to the principle of intentional analysis (ITT).\r\n\r\nPer-protocol Set: Cases with at least one oncologic efficacy assessment, compliance with the trial protocol, good compliance, no prohibited drugs during the trial, and completion of the case report form.\r\n\r\nSafety Analysis Set: All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set.\r\n\r\nStatistical analysis plan Validity analysis: for the efficacy index PFS, the Kaplan-Meier method will be used to estimate its median time and column Statistical methods: Out of two-sided 95% confidence intervals. Disease control rate (DCR = CR+PR+SD) and objective remission rate (ORR = CR+PR) were calculated using Fisher exact probability and bilateral 95% confidence intervals were presented.\r\n\r\nSafety analysis: descriptive statistical analysis was used to tabulate the AEs that occurred in this trial. laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred.\r\n\r\nTreatment protocol:\r\n\r\nAll subjects in this study were first tested for genes/proteins (HER2 protein, HER2FISH, PD-L1 protein 22C3, Claudin18.2, MMR) and received treatment in different groups according to gene/protein expression.\r\n\r\nGroup 1 HER protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine Group 2 Claudin18.2 protein-positive Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine Group 3 Her protein and Claudin18.2 protein were negative Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery + local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation. The duration of maintenance treatment was 2 years from the time of enrollment.\r\n\r\nPrincipal Investigator: Luo Suxia, Li Ning Group leader unit: Henan Cancer Hospital', 'Condition': 'Gastric Cancer\r\nGastroesophageal-junction Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nVoluntarily sign the informed consent form for this study.\r\nMale or female patients aged 18-75 years.\r\nunresectable advanced or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction (including indolent cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma) confirmed by pathological (histological or cytological) examination.\r\n>6 months from the end of prior (neo)adjuvant chemotherapy/adjuvant radiotherapy to the time of disease recurrence\r\nat least one measurable lesion or evaluable lesion according to RECIST version 1.1; measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be optional targets if progression is confirmed and they meet RECIST 1.1 criteria)\r\nECOG score: 0 to 1.\r\nLife expectancy ≥ 3 months.\r\nAdequate organ function, with the following laboratory test values required at screening.\r\nRoutine blood test criteria to be met. Hemoglobin level (HB) ≥ 90 g/L (no blood transfusion within 14 days). Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Platelet count (PLT) ≥100×109/L (no interleukin 11 or TPO within 14 days). White blood cell count (WBC) ≥4.0×109/L (no granulocyte stimulating factor within 14 days).\r\nBiochemical tests are required to meet the following criteria. Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN). ALT and AST ≤ 2.5 ULN. Cr ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60 ml/min, (Cockcroft-Gault formula).\r\nSerum albumin ≥ 25 g/L (2.5 g/dL). For subjects with liver metastases, AST and ALT must be ≤ 5 x ULN, leukocytes ≥ 4 x 109/L, untransfused platelets ≥ 100 x 109/L, absolute neutrophil value (ANC) without granulocyte-stimulating factor treatment ≥ 1.5 x 109/L, hemoglobin ≥ 90 g/L\r\n\r\nDoppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%).\r\nAdequate coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN.\r\nWomen of childbearing potential are required to use highly effective contraception for the duration of the study, and for the period after the last dose and for at least 180 days after chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration; non-sterile men are required to use highly effective contraception for the duration of the study and for at least 180 days after both the last dose and chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration.\r\nIf local treatment of metastases, such as radiotherapy or ablation, is performed, they may also be enrolled after 14 days of washout as long as an assessable lesion is still present and the local treatment is not followed by anti-tumor therapy such as targeted, chemotherapy or immunotherapy.'}
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{'Arm - Disease - Stage of Cancer': 'Locally Advanced, Advanced'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05608785
|
{'Official Title': 'Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes', 'Brief Summary': 'Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective: To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced/advanced gastric or combined gastroesophageal adenocarcinoma with different gene/protein types.\r\n\r\nEvaluation criteria: To evaluate the adverse effects of drugs using the NCI CTCAE V5.0 criteria.\r\n\r\nRECIST1.1 criteria were used to evaluate drug efficacy Study endpoints: Primary indicators Objective Response Rate (ORR) Secondary indicators 1. drug safety. 2. disease control rate DCR (CR+PR+SD). 3. duration of remission DoR. 4. disease-free survival (PFS) and overall survival time (OS). 5. R0/R1 surgical resection rate Study design: Single-center umbrella clinical trial Planned number of enrollment: Total 39-45 cases Sample size estimation: This is an exploratory study and sample size was not calculated Statistical methods: Selection of data for statistical analysis Full Analysis Set (FAS): The efficacy analysis was performed on all patients who were enrolled and used the drug at least once, according to the principle of intentional analysis (ITT).\r\n\r\nPer-protocol Set: Cases with at least one oncologic efficacy assessment, compliance with the trial protocol, good compliance, no prohibited drugs during the trial, and completion of the case report form.\r\n\r\nSafety Analysis Set: All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set.\r\n\r\nStatistical analysis plan Validity analysis: for the efficacy index PFS, the Kaplan-Meier method will be used to estimate its median time and column Statistical methods: Out of two-sided 95% confidence intervals. Disease control rate (DCR = CR+PR+SD) and objective remission rate (ORR = CR+PR) were calculated using Fisher exact probability and bilateral 95% confidence intervals were presented.\r\n\r\nSafety analysis: descriptive statistical analysis was used to tabulate the AEs that occurred in this trial. laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred.\r\n\r\nTreatment protocol:\r\n\r\nAll subjects in this study were first tested for genes/proteins (HER2 protein, HER2FISH, PD-L1 protein 22C3, Claudin18.2, MMR) and received treatment in different groups according to gene/protein expression.\r\n\r\nGroup 1 HER protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine Group 2 Claudin18.2 protein-positive Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine Group 3 Her protein and Claudin18.2 protein were negative Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery + local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation. The duration of maintenance treatment was 2 years from the time of enrollment.\r\n\r\nPrincipal Investigator: Luo Suxia, Li Ning Group leader unit: Henan Cancer Hospital', 'Condition': 'Gastric Cancer\r\nGastroesophageal-junction Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nVoluntarily sign the informed consent form for this study.\r\nMale or female patients aged 18-75 years.\r\nunresectable advanced or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction (including indolent cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma) confirmed by pathological (histological or cytological) examination.\r\n>6 months from the end of prior (neo)adjuvant chemotherapy/adjuvant radiotherapy to the time of disease recurrence\r\nat least one measurable lesion or evaluable lesion according to RECIST version 1.1; measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be optional targets if progression is confirmed and they meet RECIST 1.1 criteria)\r\nECOG score: 0 to 1.\r\nLife expectancy ≥ 3 months.\r\nAdequate organ function, with the following laboratory test values required at screening.\r\nRoutine blood test criteria to be met. Hemoglobin level (HB) ≥ 90 g/L (no blood transfusion within 14 days). Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Platelet count (PLT) ≥100×109/L (no interleukin 11 or TPO within 14 days). White blood cell count (WBC) ≥4.0×109/L (no granulocyte stimulating factor within 14 days).\r\nBiochemical tests are required to meet the following criteria. Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN). ALT and AST ≤ 2.5 ULN. Cr ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60 ml/min, (Cockcroft-Gault formula).\r\nSerum albumin ≥ 25 g/L (2.5 g/dL). For subjects with liver metastases, AST and ALT must be ≤ 5 x ULN, leukocytes ≥ 4 x 109/L, untransfused platelets ≥ 100 x 109/L, absolute neutrophil value (ANC) without granulocyte-stimulating factor treatment ≥ 1.5 x 109/L, hemoglobin ≥ 90 g/L\r\n\r\nDoppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%).\r\nAdequate coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN.\r\nWomen of childbearing potential are required to use highly effective contraception for the duration of the study, and for the period after the last dose and for at least 180 days after chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration; non-sterile men are required to use highly effective contraception for the duration of the study and for at least 180 days after both the last dose and chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration.\r\nIf local treatment of metastases, such as radiotherapy or ablation, is performed, they may also be enrolled after 14 days of washout as long as an assessable lesion is still present and the local treatment is not followed by anti-tumor therapy such as targeted, chemotherapy or immunotherapy.'}
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{'Arm - Disease - Stage of Cancer': 'Locally Advanced, Advanced'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05608785
|
{'Official Title': 'Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes', 'Brief Summary': 'Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective: To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced/advanced gastric or combined gastroesophageal adenocarcinoma with different gene/protein types.\r\n\r\nEvaluation criteria: To evaluate the adverse effects of drugs using the NCI CTCAE V5.0 criteria.\r\n\r\nRECIST1.1 criteria were used to evaluate drug efficacy Study endpoints: Primary indicators Objective Response Rate (ORR) Secondary indicators 1. drug safety. 2. disease control rate DCR (CR+PR+SD). 3. duration of remission DoR. 4. disease-free survival (PFS) and overall survival time (OS). 5. R0/R1 surgical resection rate Study design: Single-center umbrella clinical trial Planned number of enrollment: Total 39-45 cases Sample size estimation: This is an exploratory study and sample size was not calculated Statistical methods: Selection of data for statistical analysis Full Analysis Set (FAS): The efficacy analysis was performed on all patients who were enrolled and used the drug at least once, according to the principle of intentional analysis (ITT).\r\n\r\nPer-protocol Set: Cases with at least one oncologic efficacy assessment, compliance with the trial protocol, good compliance, no prohibited drugs during the trial, and completion of the case report form.\r\n\r\nSafety Analysis Set: All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set.\r\n\r\nStatistical analysis plan Validity analysis: for the efficacy index PFS, the Kaplan-Meier method will be used to estimate its median time and column Statistical methods: Out of two-sided 95% confidence intervals. Disease control rate (DCR = CR+PR+SD) and objective remission rate (ORR = CR+PR) were calculated using Fisher exact probability and bilateral 95% confidence intervals were presented.\r\n\r\nSafety analysis: descriptive statistical analysis was used to tabulate the AEs that occurred in this trial. laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred.\r\n\r\nTreatment protocol:\r\n\r\nAll subjects in this study were first tested for genes/proteins (HER2 protein, HER2FISH, PD-L1 protein 22C3, Claudin18.2, MMR) and received treatment in different groups according to gene/protein expression.\r\n\r\nGroup 1 HER protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine Group 2 Claudin18.2 protein-positive Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine Group 3 Her protein and Claudin18.2 protein were negative Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery + local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation. The duration of maintenance treatment was 2 years from the time of enrollment.\r\n\r\nPrincipal Investigator: Luo Suxia, Li Ning Group leader unit: Henan Cancer Hospital', 'Condition': 'Gastric Cancer\r\nGastroesophageal-junction Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nVoluntarily sign the informed consent form for this study.\r\nMale or female patients aged 18-75 years.\r\nunresectable advanced or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction (including indolent cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma) confirmed by pathological (histological or cytological) examination.\r\n>6 months from the end of prior (neo)adjuvant chemotherapy/adjuvant radiotherapy to the time of disease recurrence\r\nat least one measurable lesion or evaluable lesion according to RECIST version 1.1; measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be optional targets if progression is confirmed and they meet RECIST 1.1 criteria)\r\nECOG score: 0 to 1.\r\nLife expectancy ≥ 3 months.\r\nAdequate organ function, with the following laboratory test values required at screening.\r\nRoutine blood test criteria to be met. Hemoglobin level (HB) ≥ 90 g/L (no blood transfusion within 14 days). Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Platelet count (PLT) ≥100×109/L (no interleukin 11 or TPO within 14 days). White blood cell count (WBC) ≥4.0×109/L (no granulocyte stimulating factor within 14 days).\r\nBiochemical tests are required to meet the following criteria. Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN). ALT and AST ≤ 2.5 ULN. Cr ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60 ml/min, (Cockcroft-Gault formula).\r\nSerum albumin ≥ 25 g/L (2.5 g/dL). For subjects with liver metastases, AST and ALT must be ≤ 5 x ULN, leukocytes ≥ 4 x 109/L, untransfused platelets ≥ 100 x 109/L, absolute neutrophil value (ANC) without granulocyte-stimulating factor treatment ≥ 1.5 x 109/L, hemoglobin ≥ 90 g/L\r\n\r\nDoppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%).\r\nAdequate coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN.\r\nWomen of childbearing potential are required to use highly effective contraception for the duration of the study, and for the period after the last dose and for at least 180 days after chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration; non-sterile men are required to use highly effective contraception for the duration of the study and for at least 180 days after both the last dose and chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration.\r\nIf local treatment of metastases, such as radiotherapy or ablation, is performed, they may also be enrolled after 14 days of washout as long as an assessable lesion is still present and the local treatment is not followed by anti-tumor therapy such as targeted, chemotherapy or immunotherapy.'}
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{'Arm - Disease - Stage of Cancer': 'Locally Advanced, Advanced'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05715840
|
{'Official Title': 'A Randomised, Double-blind, Placebo-controlled, Multicentre Phase Ш Clinical Study to Evaluate the Efficacy and Safety of First-line Treatment With SG001 Plus Chemotherapy±Bevacizumab Versus Placebo Plus Chemotherapy±Bevacizumab for PD-L1 Positive (CPS≥1) Women With Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'This study is a randomised, double-blind, placebo-controlled, multicentre phase 3 clinical study to evaluate the efficacy and safety of SG001 plus chemotherapy±bevacizumab versus placebo plus chemotherapy±bevacizumab, as first-line treatment, in patients with PD-L1 positive (CPS≥1), Recurrent or Metastatic Cervical Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of SG001＋Chemotherapy±Bevacizumab will be assessed prior to the Phase 3 portion of the study.', 'Condition': 'Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)', 'Detailed Description': 'The purpose of this study is to assess the efficacy and safety of SG001 plus one of four platinum-based chemotherapy regimens compared to the placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult PD-L1 positive (CPS≥1) women with recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The study include two stages: the safety run-in phase and phase Ⅲ trail. Upon completion of the first stage study, the Safety Monitoring Committee (SMC) will decide whether to proceed directly to Phase Ⅲ study.\r\n\r\nThe primary study hypotheses are that the combination of SG001 plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), 2) Overall Survival (OS).', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nAge ≥ 18 and ≤ 70 on the day of signing informed consent and volunteered to participated in this study.\r\nHas histologically documented recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation).\r\n(Safety Lead-in)Has a measurable lesion per RECIST 1.1 via CT or MRI. (Phase 3) Has a assessable lesion per RECIST 1.1 via CT or MRI.\r\nHas provided enough archival tumor tissue sample or willing to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to first dose.\r\nEastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to first dose.\r\nHas a predicted survival period ≥ 3 months assessed by investigators.\r\nAdverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0.\r\nAdequate organ function as defined below:\r\n\r\nBlood routine tests (No blood transfusions and hematopoietic stimulators have been used, and no drugs have been used to correct blood cell counts ): Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelets ≥100 ×10^9/L; Hemoglobin (HGB)≥9 g/dL;\r\nSerum biochemical indexs: Serum creatinine ≤1.5 × ULN or >1.5 × ULN with creatinine clearance (CCr) ≥ 60 mL/min; Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Patients with Gilbert's syndrome can be up to 3 × ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN or ≤5 X ULN for patients with liver metastases;\r\nCoagulation function: Activated partial thromboplastin time (APPT) and International Normalized Ratio (INR)≤1.5 × ULN (No anticoagulants or other drugs affecting clotting function have been used within 14 days prior to the first dose, except for patients requiring long-term anticoagulant therapy)."}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05715840
|
{'Official Title': 'A Randomised, Double-blind, Placebo-controlled, Multicentre Phase Ш Clinical Study to Evaluate the Efficacy and Safety of First-line Treatment With SG001 Plus Chemotherapy±Bevacizumab Versus Placebo Plus Chemotherapy±Bevacizumab for PD-L1 Positive (CPS≥1) Women With Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'This study is a randomised, double-blind, placebo-controlled, multicentre phase 3 clinical study to evaluate the efficacy and safety of SG001 plus chemotherapy±bevacizumab versus placebo plus chemotherapy±bevacizumab, as first-line treatment, in patients with PD-L1 positive (CPS≥1), Recurrent or Metastatic Cervical Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of SG001＋Chemotherapy±Bevacizumab will be assessed prior to the Phase 3 portion of the study.', 'Condition': 'Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)', 'Detailed Description': 'The purpose of this study is to assess the efficacy and safety of SG001 plus one of four platinum-based chemotherapy regimens compared to the placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult PD-L1 positive (CPS≥1) women with recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The study include two stages: the safety run-in phase and phase Ⅲ trail. Upon completion of the first stage study, the Safety Monitoring Committee (SMC) will decide whether to proceed directly to Phase Ⅲ study.\r\n\r\nThe primary study hypotheses are that the combination of SG001 plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), 2) Overall Survival (OS).', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nAge ≥ 18 and ≤ 70 on the day of signing informed consent and volunteered to participated in this study.\r\nHas histologically documented recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation).\r\n(Safety Lead-in)Has a measurable lesion per RECIST 1.1 via CT or MRI. (Phase 3) Has a assessable lesion per RECIST 1.1 via CT or MRI.\r\nHas provided enough archival tumor tissue sample or willing to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to first dose.\r\nEastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to first dose.\r\nHas a predicted survival period ≥ 3 months assessed by investigators.\r\nAdverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0.\r\nAdequate organ function as defined below:\r\n\r\nBlood routine tests (No blood transfusions and hematopoietic stimulators have been used, and no drugs have been used to correct blood cell counts ): Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelets ≥100 ×10^9/L; Hemoglobin (HGB)≥9 g/dL;\r\nSerum biochemical indexs: Serum creatinine ≤1.5 × ULN or >1.5 × ULN with creatinine clearance (CCr) ≥ 60 mL/min; Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Patients with Gilbert's syndrome can be up to 3 × ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN or ≤5 X ULN for patients with liver metastases;\r\nCoagulation function: Activated partial thromboplastin time (APPT) and International Normalized Ratio (INR)≤1.5 × ULN (No anticoagulants or other drugs affecting clotting function have been used within 14 days prior to the first dose, except for patients requiring long-term anticoagulant therapy)."}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05529667
|
{'Official Title': 'An Open Label, Single-Arm, Multi-center Phase Ib/II Study to Evaluate the Safety and Efficacy of INCB054828 in Combination With Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer With FGFs/FGFRs Genetic Aberration.', 'Brief Summary': 'This study was conducted as a second-line treatment of recurrent / progressive gastric cancer patients with FGFs / FGFRs genetic mutations in the Ib / II clinical trial. The maximum maximal tolerated dose (MTD) and 2-phase recommended dose in combination with INCB054828 and paclitaxel (recommended phase II dose, RP2D), and evaluate the safety and clinical efficacy of this combination therapy. This study consists of two steps: Phase 1 is a dose escalation study to determine the maximum tolerated dose and 2-phase recommended dose of weekly paclitaxel and INCB054828 combination therapy, and Phase 2 is the dose escalation study in combination with INCB054828 and paclitaxel Assess safety and tolerability and identify antitumor effects in stomach cancer with FGFs / FGFRs genetic mutations.', 'Condition': 'Fibroblast Growth Factors (FGFs)/Fibroblast Growth Factor Receptors (FGFRs) Genetic Aberration Gastric Cancer, INCB054828, Paclitaxel', 'Detailed Description': 'phase>\r\n\r\n- Approximately 3-12 patients will be enrolled. The dose escalation will be three patients registered for each cohort until the first dose-limiting toxicity appears during the four weeks of treatment and observation. 13.5mg, once a day begins to take. The paclitaxel is administered once a week for three consecutive weeks and then for one week, followed by a total of four weeks in one cycle.\r\n\r\nphase> Phase 2 studies will be extended to a total of 30 patients with a two-phase recommended dose. Patients will be treated until the time of disease progression, intolerable toxicity, rejection of the patient, or withdrawal of consent. In its pre-screening phase, its next generation sequencing (NGS) is performed. Patients with FGFs / FGFRs genetic abnormalities may be enrolled in this study. If a patient has multiple genetic abnormalities, he or she will first be enrolled in a treatment group that targets a rare genetic abnormality. Registered patients will be treated on a continuous basis every four weeks.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients who agreed in writing to the clinical study consent\r\nHistologically or cytologically confirmed advanced gastric adenocarcinoma. Patients must have experienced objective radiological or disease progress with evidence during or after primary therapy with fluoropyrimidine and platinum.\r\nFGFs / FGFRs have genetic variation on NGS.\r\nPatients whose life expectancy is at least 3 months\r\nIf the Eastern Cooperative Oncology Group (ECOG) is 0 or 1\r\nMeasurable or assessable lesion based on RECIST 1.1 scale\r\nMust be swallowed, should be able to take oral medication\r\nPossible long-term function to receive chemotherapy.\r\nPatients receiving anti-HER2 therapy for HER2 negative or HER2-positive primary treatment'}
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{'Arm - Disease - Stage of Cancer': 'Advanced'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT04269200
|
{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\r\n\r\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥18 years at the time of screening and female.\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\nPatient must have endometrial cancer in one of the following categories:\n\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\nFPPE tumor sample must be available for MMR evaluation.\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}
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{'Arm - Disease - Stage of Cancer': 'Newly Diagnosed, Advanced, Stage III, Stage IV'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT04269200
|
{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nAge ≥18 years at the time of screening and female.\r\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\r\nPatient must have endometrial cancer in one of the following categories:\r\n\r\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\r\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\r\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\r\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\r\nFPPE tumor sample must be available for MMR evaluation.\r\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}
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{'Arm - Disease - Stage of Cancer': 'Newly Diagnosed, Advanced, Stage III, Stage IV'}
| 0
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT04269200
|
{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\r\n\r\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥18 years at the time of screening and female.\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\nPatient must have endometrial cancer in one of the following categories:\n\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\nFPPE tumor sample must be available for MMR evaluation.\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}
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{'Arm - Disease - Stage of Cancer': 'Newly Diagnosed, Advanced, Stage III, Stage IV'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT03617679
|
{'Official Title': 'A Phase II, Randomized, Double-Blind Study of the Use of Rucaparib vs. Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer', 'Brief Summary': 'This study seeks to determine the effectiveness of Rucaparib as maintenance therapy for metastatic and recurrent endometrial cancer, after 1-2 prior lines of therapy.', 'Condition': 'Metastatic Endometrial Cancer ', 'Detailed Description': 'This is a phase II clinical trial, that administers a maintenance treatment after first line chemotherapy is complete. It is designed to have a 1:1 randomization technique. Half the participants who enter the study will receive the active ingredient, Rucaparib, while the other half will receive a placebo. Treatment will be until progression with follow up until death.', 'Inclusion Criteria': "Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nProvision to sign and date the consent form.\nStated willingness to comply with all study procedures and be available for the duration of the study.\nBe a female aged 18-89.\nPatients with a primary Stage III/IV or recurrent endometrial cancer.\nPatients have received at least one prior chemotherapy regimen and no more than two prior cytotoxic regimens (including hormonal therapy).\nPrimary chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles.\nPrevious cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks from initiation after last dose of previous therapy.\nPatients who receive radiation to the whole pelvis or at least 50% of the spine must complete radiation therapy and have at least 4 weeks' time elapse prior to initiation of drug.\nECOG performance status of 0, 1 or 2.\nANC > or = 1500 cells/microliters\nPlatelet count > 100,000 microliters\nHemoglobin > or = 9.0 g/dL\nSerum albumin > or = 2.5 g/dL\nTotal bilirubin ≤ 1.5 x ULN\nAST and ALT ≤ 3.0 x ULN\nSerum Creatinine ≤ 1.5x ULN"}
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{'Arm - Disease - Stage of Cancer': 'Stage III, Stage IV, Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT03617679
|
{'Official Title': 'A Phase II, Randomized, Double-Blind Study of the Use of Rucaparib vs. Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer', 'Brief Summary': 'This study seeks to determine the effectiveness of Rucaparib as maintenance therapy for metastatic and recurrent endometrial cancer, after 1-2 prior lines of therapy.', 'Condition': 'Metastatic Endometrial Cancer ', 'Detailed Description': 'This is a phase II clinical trial, that administers a maintenance treatment after first line chemotherapy is complete. It is designed to have a 1:1 randomization technique. Half the participants who enter the study will receive the active ingredient, Rucaparib, while the other half will receive a placebo. Treatment will be until progression with follow up until death.', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\r\n\r\nProvision to sign and date the consent form.\r\nStated willingness to comply with all study procedures and be available for the duration of the study.\r\nBe a female aged 18-89.\r\nPatients with a primary Stage III/IV or recurrent endometrial cancer.\r\nPatients have received at least one prior chemotherapy regimen and no more than two prior cytotoxic regimens (including hormonal therapy).\r\nPrimary chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles.\r\nPrevious cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks from initiation after last dose of previous therapy.\r\nPatients who receive radiation to the whole pelvis or at least 50% of the spine must complete radiation therapy and have at least 4 weeks' time elapse prior to initiation of drug.\r\nECOG performance status of 0, 1 or 2.\r\nANC > or = 1500 cells/microliters\r\nPlatelet count > 100,000 microliters\r\nHemoglobin > or = 9.0 g/dL\r\nSerum albumin > or = 2.5 g/dL\r\nTotal bilirubin ≤ 1.5 x ULN\r\nAST and ALT ≤ 3.0 x ULN\r\nSerum Creatinine ≤ 1.5x ULN"}
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{'Arm - Disease - Stage of Cancer': 'Stage III, Stage IV, Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05422911
|
{'Official Title': 'A Phase 2 Randomized Study of YONSA® (Abiraterone Acetate), Enzalutamide or Apalutamide as First Line Therapy in Veterans With Castrate-sensitive Prostate Cancer', 'Brief Summary': 'The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be explored. In the egalitarian system that is the VHA the treatment of prostate cancer is excellent, uniform across the US and indifferent to race. The choices made are clearly personalized, given not all men received all therapies and that younger Veterans were treated more aggressively.\n\nBut with survivals that rival those in registration trials that enroll optimally fit individuals usually not encumbered by the co-morbidities that afflict many Veterans, the outcomes are testimony to the fact that for this common malady of older Veterans with whom VA physicians have broad experience the care administered is unsurpassed. Importantly this care at least as regards Veterans with mCRPC demonstrates that given equal access to health care, African Americans with prostate cancer fared as well if not better than Caucasians and importantly had better outcomes with abiraterone, an observation needing further exploration as these therapies move up front.', 'Condition': 'Metastatic Cancer\nNeoplasm, Prostate', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nVeterans must meet the following to be eligible to participate:\n\nBe willing and able to provide written informed consent for the trial.\n\nAge ≥18 years of age on day of signing informed consent.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death).\n\nHistologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet-cell features, or small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.\n\nHave been receiving or will receive androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist or have undergone bilateral orchiectomy (i.e., medical, or surgical castration).\n\nHigh risk for the development of progression of disease/metastasis, defined as (i) a minimum of three rising PSA values (PSA1 < PSA2 < PSA3) at an interval of at least 1 week apart; (ii) a PSA level of 2 ng per milliliter (2 μg/L) or greater; and (iii) a PSA doubling time of 9 months or less during continuous androgen-deprivation therapy (bilateral orchiectomy or treatment with gonadotropin-releasing hormone analogue agonists or antagonists) as calculated with the use of the method of Pound et al.\n\nHas not received abiraterone acetate, enzalutamide, or apalutamide at the time of enrollment.\n\nHave a predicted life expectancy of >12 months.\nFor patients receiving bisphosphonates or denosumab, dose must be stable for at least 4 weeks before randomization.\n\nAble to swallow the study drug and comply with study requirements.\n\nLaboratory tests meet minimum safety requirements:\n\nHepatic: AST ≤2.5 X institutional ULN, ALT ≤2.5 X institutional ULN\nRenal: Creatinine clearance ≥30 ml/min or serum creatinine ≤1.8 mg/dl\nHematological: Absolute neutrophil count ≥1000/mm3, Platelet count ≥100,000/mm3; Hemoglobin >9 g/dL Note: The presence of metastatic disease as assessed by any modality is not a contraindication for enrollment.'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05422911
|
{'Official Title': 'A Phase 2 Randomized Study of YONSA® (Abiraterone Acetate), Enzalutamide or Apalutamide as First Line Therapy in Veterans With Castrate-sensitive Prostate Cancer', 'Brief Summary': 'The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be explored. In the egalitarian system that is the VHA the treatment of prostate cancer is excellent, uniform across the US and indifferent to race. The choices made are clearly personalized, given not all men received all therapies and that younger Veterans were treated more aggressively.\r\n\r\nBut with survivals that rival those in registration trials that enroll optimally fit individuals usually not encumbered by the co-morbidities that afflict many Veterans, the outcomes are testimony to the fact that for this common malady of older Veterans with whom VA physicians have broad experience the care administered is unsurpassed. Importantly this care at least as regards Veterans with mCRPC demonstrates that given equal access to health care, African Americans with prostate cancer fared as well if not better than Caucasians and importantly had better outcomes with abiraterone, an observation needing further exploration as these therapies move up front.', 'Condition': 'Metastatic Cancer\nNeoplasm, Prostate', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nVeterans must meet the following to be eligible to participate:\n\nBe willing and able to provide written informed consent for the trial.\n\nAge ≥18 years of age on day of signing informed consent.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death).\n\nHistologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet-cell features, or small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.\n\nHave been receiving or will receive androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist or have undergone bilateral orchiectomy (i.e., medical, or surgical castration).\n\nHigh risk for the development of progression of disease/metastasis, defined as (i) a minimum of three rising PSA values (PSA1 < PSA2 < PSA3) at an interval of at least 1 week apart; (ii) a PSA level of 2 ng per milliliter (2 μg/L) or greater; and (iii) a PSA doubling time of 9 months or less during continuous androgen-deprivation therapy (bilateral orchiectomy or treatment with gonadotropin-releasing hormone analogue agonists or antagonists) as calculated with the use of the method of Pound et al.\n\nHas not received abiraterone acetate, enzalutamide, or apalutamide at the time of enrollment.\n\nHave a predicted life expectancy of >12 months.\nFor patients receiving bisphosphonates or denosumab, dose must be stable for at least 4 weeks before randomization.\n\nAble to swallow the study drug and comply with study requirements.\n\nLaboratory tests meet minimum safety requirements:\n\nHepatic: AST ≤2.5 X institutional ULN, ALT ≤2.5 X institutional ULN\nRenal: Creatinine clearance ≥30 ml/min or serum creatinine ≤1.8 mg/dl\nHematological: Absolute neutrophil count ≥1000/mm3, Platelet count ≥100,000/mm3; Hemoglobin >9 g/dL Note: The presence of metastatic disease as assessed by any modality is not a contraindication for enrollment.'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT04934722
|
{'Official Title': 'A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)', 'Brief Summary': 'This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT in Chinese participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS).\r\n\r\nAs of Amendment 4, the study is being stopped for futility. All the prespecified interim analyses after interim analysis 1 (IA1) and final analysis of the study described in the statistical analysis plan (SAP) will not be performed. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase.', 'Condition': 'Metastatic Hormone-Sensitive Prostate Cancer', 'Detailed Description': 'The China extension study will include participants previously enrolled in China in the global study for MK-3475-991 (NCT04191096) plus those enrolled during the China extension enrollment period. A total of approximately 186 Chinese participants will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale participants with histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\r\nHas metastatic disease assessed by investigator and verified by BICR by either ≥2 bone lesions on bone scan and/or visceral disease by computed tomography/magnetic resonance imaging (CT/MRI)\r\nWilling to maintain continuous ADT with a LHRH agonists or antagonists during study treatment or have a history of bilateral orchiectomy\r\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 10 days of randomization\r\nParticipants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization\r\nHas adequate organ function\r\nHas provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample\r\nMale participants must agree to the following during the intervention period and for at least 120 days after the last dose of study intervention: Refrain from donating sperm PLUS either be abstinent from heterosexual intercourse and agree to remain abstinent OR agree to use contraception, unless confirmed to be azoospermic\r\nMale participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex'}
|
{'Arm - Disease - Stage of Cancer': 'Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT04934722
|
{'Official Title': 'A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)', 'Brief Summary': 'This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT in Chinese participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS).\r\n\r\nAs of Amendment 4, the study is being stopped for futility. All the prespecified interim analyses after interim analysis 1 (IA1) and final analysis of the study described in the statistical analysis plan (SAP) will not be performed. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase.', 'Condition': 'Metastatic Hormone-Sensitive Prostate Cancer', 'Detailed Description': 'The China extension study will include participants previously enrolled in China in the global study for MK-3475-991 (NCT04191096) plus those enrolled during the China extension enrollment period. A total of approximately 186 Chinese participants will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale participants with histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\r\nHas metastatic disease assessed by investigator and verified by BICR by either ≥2 bone lesions on bone scan and/or visceral disease by computed tomography/magnetic resonance imaging (CT/MRI)\r\nWilling to maintain continuous ADT with a LHRH agonists or antagonists during study treatment or have a history of bilateral orchiectomy\r\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 10 days of randomization\r\nParticipants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization\r\nHas adequate organ function\r\nHas provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample\r\nMale participants must agree to the following during the intervention period and for at least 120 days after the last dose of study intervention: Refrain from donating sperm PLUS either be abstinent from heterosexual intercourse and agree to remain abstinent OR agree to use contraception, unless confirmed to be azoospermic\r\nMale participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex'}
|
{'Arm - Disease - Stage of Cancer': 'Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05201352
|
{'Official Title': 'Multicentric Randomized Phase I/II Study to Evaluate Efficacy of Trifluridine/Tipiracil Plus XB2001 (Anti-IL-1α True Human Antibody) Versus Trifluridine/Tipiracil Plus Placebo in Metastatic Colorectal Cancer Patients After Failure of Oxaliplatin, Irinotecan, Fluoropyrimidine', 'Brief Summary': 'Unresectable metastatic colorectal cancer (mCRC) remains an incurable disease. After failure of conventional treatments involving fluoropyrimidines, oxaliplatin and irinotecan in combination or not with biotherapies targeting EGFR and VEGF; regorafenib shows a modest improvement in overall survival. Recently, trifluridine/tipiracil has also shown efficacy in phase 3 with an overall survival of around 7 months. Trifluridine/tipiracil has become the standard of care for advanced mCRC in most western countries. However, the objective response rate remains very low and the survival gain remains moderate (+2 months). Therefore, new strategies are needed to ensure that mCRC patients who have received multiple lines of therapy can receive more effective treatments.\r\n\r\nBased on previous clinical trials on IL-1 inhibition and our preclinical data, IL-1 inhibition may increase the efficacy of trifluridine/tipiracil. The goal is to test whether the addition of XB2001 to trifluridine/tipiracil could be synergistic.', 'Condition': 'Metastatic Colorectal Cancer', 'Detailed Description': 'This project proposes to evaluate trifluridine/tipiracil plus XB2001 in patients with metastatic colorectal cancer previously treated with oxaliplatin, fluoropyrimidine and irinotecan in combination or not with an anti-angiogenic and an anti-EGFR for RAS Wild type tumor.\r\n\r\nThe project will consist of a randomized (1:1 ratio), double-blind, non-comparative, multi-center Phase II study with two treatment arms:\r\n\r\nExperimental arm: trifluridine/tipiracil + XB2001\r\nControl arm: trifluridine/tipiracil + placebo', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nMale or female that must have signed a written informed consent prior to any study specific procedures\r\nAged ≥ 18 years at randomization\r\nPatient with histologically proven metastatic colorectal cancer previously treated for metastatic disease by chemotherapy treatment including oxaliplatin, irinotecan, fluoropyrimidine, antiangiogenic (anti-VEGF: bevacizumab or aflibercept) and anti-EGFR (cetuximab or panitumumab) if indicated (MSI tumor could be included if previously pretreated with anti PD1/PDL1 therapy)\r\nHave a performance status of 0 or 1 according to the WHO Easter Cooperative Oncology Group (ECOG)\r\nKnowledge of RAS, BRAF, Microsatellite status\r\nBaseline tumoral evaluation (thoraco-abdomino-pelvic computed tomography) perfromed within 21 days before randomization with at least one measurable lesion according to RECIST 1.1 criteria.\r\nPatient willing and able to comply with protocol for the duration of the study including: scheduled visits and exams, visits during the follow-up and treatment compliance.\r\nAdequat hepatic, renal and bone marrow function within the following limits:\r\nTotal bilirubin ≤ 1,5 times the upper limit of normal (ULN) (unless documented Gilbert's syndrome);\r\nASAT et ALAT ≤ 5 times ULN;\r\nMeasured Creatinine clearance (Cockcroft and Gault) > 30 ml / min\r\nAbsolute Neutrophil Count (ANC) > 1,5. 109 / L;\r\nPlatelet count ≥ 150. 109 / L;\r\nHaemoglobin ≥ 9 g / dL (patients can be included even if they have been transfused)\r\nAlbuminemia ≥ 30 g / L;\r\nNegative Hepatitis B, C and HIV serologies, or absence of active B or C hepatitis\r\nUrea protein, urine dipstick should be less than 2 crossese or <1g/kg\r\nAvailability of tumor material dated less than 2 years with sufficient quantity (15 to 20 whithe slides)\r\nPatient must be affiliated to a social health insurance\r\nEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients (urine within 72h or serum pregnancy within 14 days prior to inclusion).\r\nWomen of childbearing potential willing to use adequate contraception method (including the use of a mechanical method of contraception in the event of hormonal contraceptive treatment) during the treatment period and 6 months following the end of treatment.\r\nMale patients with a partner of childbearing potential should use effective contraception during treatment and for up to 6 months after stopping treatment.\r\nNormal ECG or ECG without clinically significant findings with QTc < 470 ms."}
|
{'Arm - Disease - Stage of Cancer': 'Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05201352
|
{'Official Title': 'Multicentric Randomized Phase I/II Study to Evaluate Efficacy of Trifluridine/Tipiracil Plus XB2001 (Anti-IL-1α True Human Antibody) Versus Trifluridine/Tipiracil Plus Placebo in Metastatic Colorectal Cancer Patients After Failure of Oxaliplatin, Irinotecan, Fluoropyrimidine', 'Brief Summary': 'Unresectable metastatic colorectal cancer (mCRC) remains an incurable disease. After failure of conventional treatments involving fluoropyrimidines, oxaliplatin and irinotecan in combination or not with biotherapies targeting EGFR and VEGF; regorafenib shows a modest improvement in overall survival. Recently, trifluridine/tipiracil has also shown efficacy in phase 3 with an overall survival of around 7 months. Trifluridine/tipiracil has become the standard of care for advanced mCRC in most western countries. However, the objective response rate remains very low and the survival gain remains moderate (+2 months). Therefore, new strategies are needed to ensure that mCRC patients who have received multiple lines of therapy can receive more effective treatments.\n\nBased on previous clinical trials on IL-1 inhibition and our preclinical data, IL-1 inhibition may increase the efficacy of trifluridine/tipiracil. The goal is to test whether the addition of XB2001 to trifluridine/tipiracil could be synergistic.', 'Condition': 'Metastatic Colorectal Cancer', 'Detailed Description': 'This project proposes to evaluate trifluridine/tipiracil plus XB2001 in patients with metastatic colorectal cancer previously treated with oxaliplatin, fluoropyrimidine and irinotecan in combination or not with an anti-angiogenic and an anti-EGFR for RAS Wild type tumor.\r\n\r\nThe project will consist of a randomized (1:1 ratio), double-blind, non-comparative, multi-center Phase II study with two treatment arms:\r\n\r\nExperimental arm: trifluridine/tipiracil + XB2001\r\nControl arm: trifluridine/tipiracil + placebo', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nMale or female that must have signed a written informed consent prior to any study specific procedures\r\nAged ≥ 18 years at randomization\r\nPatient with histologically proven metastatic colorectal cancer previously treated for metastatic disease by chemotherapy treatment including oxaliplatin, irinotecan, fluoropyrimidine, antiangiogenic (anti-VEGF: bevacizumab or aflibercept) and anti-EGFR (cetuximab or panitumumab) if indicated (MSI tumor could be included if previously pretreated with anti PD1/PDL1 therapy)\r\nHave a performance status of 0 or 1 according to the WHO Easter Cooperative Oncology Group (ECOG)\r\nKnowledge of RAS, BRAF, Microsatellite status\r\nBaseline tumoral evaluation (thoraco-abdomino-pelvic computed tomography) perfromed within 21 days before randomization with at least one measurable lesion according to RECIST 1.1 criteria.\r\nPatient willing and able to comply with protocol for the duration of the study including: scheduled visits and exams, visits during the follow-up and treatment compliance.\r\nAdequat hepatic, renal and bone marrow function within the following limits:\r\nTotal bilirubin ≤ 1,5 times the upper limit of normal (ULN) (unless documented Gilbert's syndrome);\r\nASAT et ALAT ≤ 5 times ULN;\r\nMeasured Creatinine clearance (Cockcroft and Gault) > 30 ml / min\r\nAbsolute Neutrophil Count (ANC) > 1,5. 109 / L;\r\nPlatelet count ≥ 150. 109 / L;\r\nHaemoglobin ≥ 9 g / dL (patients can be included even if they have been transfused)\r\nAlbuminemia ≥ 30 g / L;\r\nNegative Hepatitis B, C and HIV serologies, or absence of active B or C hepatitis\r\nUrea protein, urine dipstick should be less than 2 crossese or <1g/kg\r\nAvailability of tumor material dated less than 2 years with sufficient quantity (15 to 20 whithe slides)\r\nPatient must be affiliated to a social health insurance\r\nEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients (urine within 72h or serum pregnancy within 14 days prior to inclusion).\r\nWomen of childbearing potential willing to use adequate contraception method (including the use of a mechanical method of contraception in the event of hormonal contraceptive treatment) during the treatment period and 6 months following the end of treatment.\r\nMale patients with a partner of childbearing potential should use effective contraception during treatment and for up to 6 months after stopping treatment.\r\nNormal ECG or ECG without clinically significant findings with QTc < 470 ms."}
|
{'Arm - Disease - Stage of Cancer': 'Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03875235
|
{'Official Title': 'A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers', 'Brief Summary': 'Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)', 'Condition': 'Biliary Tract Neoplasms', 'Detailed Description': 'A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine Plus Cisplatin Versus Placebo in Combination with Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.\nPatients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.\nPatient with recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.\nWHO/ECOG PS of 0 or 1'}
|
{'Arm - Disease - Stage of Cancer': 'Advanced, Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03875235
|
{'Official Title': 'A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers', 'Brief Summary': 'Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)', 'Condition': 'Biliary Tract Neoplasms', 'Detailed Description': 'A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine Plus Cisplatin Versus Placebo in Combination with Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.\nPatients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.\nPatient with recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.\nWHO/ECOG PS of 0 or 1'}
|
{'Arm - Disease - Stage of Cancer': 'Advanced, Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT01972217
|
{'Official Title': 'A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatment in Patients With Metastatic Castrate-Resistant Prostate Cancer Who Have Received Prior Chemotherapy Containing Docetaxel', 'Brief Summary': 'This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo given in addition to abiraterone. Abiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg twice daily (bid) will be administered with the abiraterone in this study.', 'Condition': 'Metastatic Castration-resistant Prostate Cancer', 'Detailed Description': 'This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and PK of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo-controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo in addition to abiraterone.\r\n\r\nAbiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg bid will be administered with the abiraterone in this study, but throughout this protocol the treatment will be referred to simply as abiraterone.\r\n\r\nFor Part A of the study, 15 to 18 evaluable patients (Cohorts 1 and 2) are planned to be enrolled from approximately 4 sites in approximately 1 or 2 countries, and a further 12 patients may be recruited into a 3rd cohort if necessary.\r\n\r\nFor Part B of the study, approximately 140 patients who have received prior chemotherapy containing docetaxel will be randomised from approximately 40 sites in North America and Europe. Patients who have been dosed in Part A of the study may not participate in Part B.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nProvision of signed and dated written informed consent prior to any study specific procedures.\r\nMale aged 18 years and older.\r\nHistologically or cytologically proven diagnosis of prostate cancer.\r\nCandidate for abiraterone therapy with documented evidence of metastatic castration-resistant prostate cancer. Metastatic status is defined as at least one documented metastatic lesion on either bone scan or CT/MRI scan. Castration resistant prostate cancer is defined as rising PSA or other signs of disease progression despite treatment with androgen deprivation therapy and the presence of a castrate level of testosterone (≤50 ng/dL).\r\nEastern Cooperative Oncology Group (ECOG) performance status 0 to 2 with no deterioration over the previous 2 weeks.\r\nPatients must have a life expectancy ≥12 weeks.\r\nPatients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations, and completing PRO instruments.\r\nPatients must be on a stable concomitant medication regimen, defined as no changes in medication or in dose within 2 weeks prior to start of olaparib dosing, except for bisphosphonates, denosumab and corticosteroids, which should be stable for at least 4 weeks prior to start of olaparib dosing.\r\nFor the randomised phase only, patients must have received chemotherapy in the form of docetaxel treatment for metastatic castration-resistant prostate cancer. Note: patients who discontinued docetaxel for toxicity reasons and without completing the full course will still be eligible to enter this study provided they received at least 2 cycles of chemotherapy.\r\nProvide informed consent for the pharmacogenetic sampling and analyses.'}
|
{'Arm - Disease - Stage of Cancer': 'Metastatic '}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT01972217
|
{'Official Title': 'A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatment in Patients With Metastatic Castrate-Resistant Prostate Cancer Who Have Received Prior Chemotherapy Containing Docetaxel', 'Brief Summary': 'This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo given in addition to abiraterone. Abiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg twice daily (bid) will be administered with the abiraterone in this study.', 'Condition': 'Metastatic Castration-resistant Prostate Cancer', 'Detailed Description': 'This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and PK of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo-controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo in addition to abiraterone.\r\n\r\nAbiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg bid will be administered with the abiraterone in this study, but throughout this protocol the treatment will be referred to simply as abiraterone.\r\n\r\nFor Part A of the study, 15 to 18 evaluable patients (Cohorts 1 and 2) are planned to be enrolled from approximately 4 sites in approximately 1 or 2 countries, and a further 12 patients may be recruited into a 3rd cohort if necessary.\r\n\r\nFor Part B of the study, approximately 140 patients who have received prior chemotherapy containing docetaxel will be randomised from approximately 40 sites in North America and Europe. Patients who have been dosed in Part A of the study may not participate in Part B.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nProvision of signed and dated written informed consent prior to any study specific procedures.\r\nMale aged 18 years and older.\r\nHistologically or cytologically proven diagnosis of prostate cancer.\r\nCandidate for abiraterone therapy with documented evidence of metastatic castration-resistant prostate cancer. Metastatic status is defined as at least one documented metastatic lesion on either bone scan or CT/MRI scan. Castration resistant prostate cancer is defined as rising PSA or other signs of disease progression despite treatment with androgen deprivation therapy and the presence of a castrate level of testosterone (≤50 ng/dL).\r\nEastern Cooperative Oncology Group (ECOG) performance status 0 to 2 with no deterioration over the previous 2 weeks.\r\nPatients must have a life expectancy ≥12 weeks.\r\nPatients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations, and completing PRO instruments.\r\nPatients must be on a stable concomitant medication regimen, defined as no changes in medication or in dose within 2 weeks prior to start of olaparib dosing, except for bisphosphonates, denosumab and corticosteroids, which should be stable for at least 4 weeks prior to start of olaparib dosing.\r\nFor the randomised phase only, patients must have received chemotherapy in the form of docetaxel treatment for metastatic castration-resistant prostate cancer. Note: patients who discontinued docetaxel for toxicity reasons and without completing the full course will still be eligible to enter this study provided they received at least 2 cycles of chemotherapy.\r\nProvide informed consent for the pharmacogenetic sampling and analyses.'}
|
{'Arm - Disease - Stage of Cancer': 'Metastatic '}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05797831
|
{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}
|
{'Arm - Disease - Stage of Cancer': 'Advanced'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05797831
|
{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}
|
{'Arm - Disease - Stage of Cancer': 'Advanced'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05797831
|
{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}
|
{'Arm - Disease - Stage of Cancer': 'Advanced'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05797831
|
{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}
|
{'Arm - Disease - Stage of Cancer': 'Advanced'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05797831
|
{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}
|
{'Arm - Disease - Stage of Cancer': 'Advanced'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05797831
|
{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}
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{'Arm - Disease - Stage of Cancer': 'Advanced'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05797831
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{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}
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{'Arm - Disease - Stage of Cancer': 'Advanced'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT04634877
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{'Official Title': 'A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)', 'Brief Summary': 'The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nHas a histologically confirmed new diagnosis of Endometrial Carcinoma or Carcinosarcoma (Mixed Mullerian Tumor) and:\r\n\r\nHas undergone curative intent surgery that included hysterectomy and bilateral salpingo-oophorectomy; and\r\nIs at high risk for recurrence following treatment with curative intent surgery, ie: Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) 2009 surgical stage I/II with myometrial invasion of non-endometrioid histology; FIGO 2009 surgical stage I/II with myometrial invasion of any histology with known aberrant p53 expression or p53 mutation; or FIGO (2009) surgical stage III or IVA of any histology.\r\nIs disease-free with no evidence of loco-regional disease or distant metastasis post operatively and on imaging.\r\nHas not received any radiation or systemic therapy, including immunotherapy, hormonal therapy, or hyperthermic intraperitoneal chemotherapy (HIPEC), in any setting including the neoadjuvant setting for endometrial cancer (EC).\r\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.\r\nSubmission of a tumor tissue sample from current diagnosis of Endometrial Carcinoma or Carcinosarcoma for prospective determination of histology and mismatch repair (MMR) status by central vendor is required for all participants.\r\nHas adequate organ function within 7 days of randomization."}
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{'Arm - Disease - Stage of Cancer': 'Newly Diagnosed,'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT04634877
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{'Official Title': 'A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)', 'Brief Summary': 'The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nHas a histologically confirmed new diagnosis of Endometrial Carcinoma or Carcinosarcoma (Mixed Mullerian Tumor) and:\r\n\r\nHas undergone curative intent surgery that included hysterectomy and bilateral salpingo-oophorectomy; and\r\nIs at high risk for recurrence following treatment with curative intent surgery, ie: Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) 2009 surgical stage I/II with myometrial invasion of non-endometrioid histology; FIGO 2009 surgical stage I/II with myometrial invasion of any histology with known aberrant p53 expression or p53 mutation; or FIGO (2009) surgical stage III or IVA of any histology.\r\nIs disease-free with no evidence of loco-regional disease or distant metastasis post operatively and on imaging.\r\nHas not received any radiation or systemic therapy, including immunotherapy, hormonal therapy, or hyperthermic intraperitoneal chemotherapy (HIPEC), in any setting including the neoadjuvant setting for endometrial cancer (EC).\r\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.\r\nSubmission of a tumor tissue sample from current diagnosis of Endometrial Carcinoma or Carcinosarcoma for prospective determination of histology and mismatch repair (MMR) status by central vendor is required for all participants.\r\nHas adequate organ function within 7 days of randomization."}
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{'Arm - Disease - Stage of Cancer': 'Newly Diagnosed'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT02043678
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{'Official Title': 'A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer(CRPC)', 'Brief Summary': 'To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.', 'Condition': 'Prostatic Neoplasms', 'Detailed Description': 'This study is a phase III multinational, multicenter,randomized, double blind, placebo controlled, study with a randomization allocation ratio of 1:1 (radium-223 dichloride plus abiraterone acetate plus prednisone/prednisolone: placebo plus abiraterone acetate plus prednisone/prednisolone). Until the final overall survival (OS) analysis, the study period consisted of screening / randomization, treatment, active follow-up with clinic visits, active follow-up without clinic visits, and longterm follow-up phases. Up until this point, subjects received study treatment (radium-223 dichloride or placebo in addition to abiraterone acetate plus prednisone / prednisolone for the first 6 cycles followed by abiraterone acetate plus prednisone / prednisolone thereafter) until an on-study SSE occurred (or other withdrawal criteria were met). After the final OS analysis (after implementation of Amendment 7), in order to reduce the burden to study subjects, evaluation of efficacy and exploratory endpoints will be discontinued, except for symptomatic skeletal event (SSE) and OS. Subjects who are discontinued from study treatment will initiate the long-term follow-up period; therefore, active follow-up periods will no longer be applicable. Subjects who are in active follow-up at the time of Amendment 7 is implemented should have the end of active follow-up completed (protocol driven decision) and should be directly transitioned into the extended safety follow-up study. Long term follow-up will continue until the subject dies, is lost to follow-up, withdraws informed consent, actively objects to collection of further data , or is transitioned to the extended safety follow-up study. Subjects will be followed for safety for up to 7 years, which eventually will be completed in this study or in the extended safety follow-up study.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically confirmed adenocarcinoma of the prostate\r\nMale subjects of age ≥ 18 years\r\nProstate cancer progression documented by prostate specific antigen (PSA) according to the Prostate Cancer Working Group 2 (PCWG2) criteria or radiological progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1\r\nTwo or more bone metastases on bone scan within 4 weeks prior to randomization with no lung, liver, other visceral and/or brain metastasis\r\nAsymptomatic or mildly symptomatic prostate cancer\r\nSubjects who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment\r\nMaintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7nmol/L)\r\nEastern Cooperative Oncology Group performance status (ECOG PS) score 0 or 1'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT02043678
|
{'Official Title': 'A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer(CRPC)', 'Brief Summary': 'To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.', 'Condition': 'Prostatic Neoplasms', 'Detailed Description': 'This study is a phase III multinational, multicenter,randomized, double blind, placebo controlled, study with a randomization allocation ratio of 1:1 (radium-223 dichloride plus abiraterone acetate plus prednisone/prednisolone: placebo plus abiraterone acetate plus prednisone/prednisolone). Until the final overall survival (OS) analysis, the study period consisted of screening / randomization, treatment, active follow-up with clinic visits, active follow-up without clinic visits, and longterm follow-up phases. Up until this point, subjects received study treatment (radium-223 dichloride or placebo in addition to abiraterone acetate plus prednisone / prednisolone for the first 6 cycles followed by abiraterone acetate plus prednisone / prednisolone thereafter) until an on-study SSE occurred (or other withdrawal criteria were met). After the final OS analysis (after implementation of Amendment 7), in order to reduce the burden to study subjects, evaluation of efficacy and exploratory endpoints will be discontinued, except for symptomatic skeletal event (SSE) and OS. Subjects who are discontinued from study treatment will initiate the long-term follow-up period; therefore, active follow-up periods will no longer be applicable. Subjects who are in active follow-up at the time of Amendment 7 is implemented should have the end of active follow-up completed (protocol driven decision) and should be directly transitioned into the extended safety follow-up study. Long term follow-up will continue until the subject dies, is lost to follow-up, withdraws informed consent, actively objects to collection of further data , or is transitioned to the extended safety follow-up study. Subjects will be followed for safety for up to 7 years, which eventually will be completed in this study or in the extended safety follow-up study.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically confirmed adenocarcinoma of the prostate\r\nMale subjects of age ≥ 18 years\r\nProstate cancer progression documented by prostate specific antigen (PSA) according to the Prostate Cancer Working Group 2 (PCWG2) criteria or radiological progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1\r\nTwo or more bone metastases on bone scan within 4 weeks prior to randomization with no lung, liver, other visceral and/or brain metastasis\r\nAsymptomatic or mildly symptomatic prostate cancer\r\nSubjects who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment\r\nMaintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7nmol/L)\r\nEastern Cooperative Oncology Group performance status (ECOG PS) score 0 or 1'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT01068249
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{'Official Title': 'A Phase II Study of Letrozole and RAD001 (Everolimus) in Patients With Advanced or Recurrent Endometrial Cancer', 'Brief Summary': 'The goal of this clinical research study is to learn if the combination of RAD001 (everolimus) and Femara (letrozole) can help to control recurrent or progressive endometrial cancer. The safety of this drug combination will also be studied.', 'Condition': 'Endometrial Cancer', 'Detailed Description': 'The Study Drugs:\r\n\r\nEverolimus is designed to stop cancer cells from multiplying. It may also stop the growth of new blood vessels that help tumor growth, which may cause the tumor cells to die.\r\n\r\nLetrozole is designed to block chemical pathways that are necessary for tumor growth.\r\n\r\nStudy Drug Administration:\r\n\r\nIf you are found to be eligible to take part in this study, you will take 2 pills of everolimus by mouth 1 time every day. You should not open everolimus until you are about to take it because it absorbs moisture and is sensitive to light. You will also take 1 pill of letrozole by mouth 1 time every day. You should take letrozole at the same time as everolimus.\r\n\r\nEverolimus should be taken the same time every day on an empty stomach (fasting state) or after no more than a light, fat-free meal. You should wait at least 6 hours after a eating a regular (not fat-free meal) before taking everolimus. You should not eat fatty foods for at least 1 hour after taking everolimus.\r\n\r\nIf you cannot swallow the tablets, the tablets should be dissolved in a glass of about 2 tablespoons of water just before being taken. The tablets should then be stirred gently (for a maximum of 7 minutes) until the tablets are dissolved. The contents should then be drunk. If you vomit after taking the study drug, you should not take another tablet that day. If you forgot to take the drug one day, you should not take an extra dose the next day but instead contact your doctor for advice.\r\n\r\nYou will be given a diary where you will record the pills you take each day. You must bring this diary to each visit.\r\n\r\nWhile you are on study, you should avoid grapefruit, grapefruit juice, and other products containing grapefruit. There are also certain drugs you cannot take during this study. You should not take any drugs during the study without asking the study doctor first.\r\n\r\nStudy Visits:\r\n\r\nEvery 4 weeks, the following tests and procedures will be performed:\r\n\r\nYou will have a physical exam, including measurement of your weight and vital signs (blood pressure, heart rate, breathing rate, and temperature).\r\nYour performance status will be recorded.\r\nBlood (about 2 tablespoons) will be drawn for routine tests, including checking your liver and kidneys and measuring the levels of sugar in your blood, and levels of fat in your blood.\r\nYou will asked about any side effects you have experienced.\r\nIf the disease is in the pelvis, you will have a pelvic exam.\r\nIf the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn for hepatitis testing.\r\nYour pills will be counted.\r\nAt Week 8, the following tests and procedures will be performed:\r\n\r\nYou will have a physical exam, including a pelvic exam.\r\nYou will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.\r\nAny tumors will be measured. The doctor will either feel the tumor or a CT, x-ray, and/or MRI will be used.\r\nIf the disease is in your chest, you will have chest CT and/or MRI scan to check the status of the disease.\r\nYou will asked about any side effects you have experienced.\r\nAfter the Week 8 Visit, you will have the following tests and procedures. (If the disease has partially or completely responded to the study drugs, these tests will be done around Week 12. If the disease is stable, these tests will be done around Week 16.)\r\n\r\nYou will have a physical exam.\r\nYou will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.\r\nAny tumors will be measured. The doctor will either feel the tumor or a CT scan, x-ray, and/or MRI will be used.\r\nIf the disease is in your chest, you will have a chest CT and/or MRI scan to check the status of the disease.\r\nAfter the Week 12 or 16 visit, every 12 weeks, the following tests and procedures will be performed:\r\n\r\nYou will have a pelvic exam.\r\nYou will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.\r\nI-f the disease is in your chest, you will have chest CT and/or MRI scan to check the status of the disease.\r\n\r\nLength of Study:\r\n\r\nYou may continue receiving additional cycles of study treatment. You will be taken off study if you experience intolerable side effects, the disease gets worse, the disease completely responds, or the doctor thinks it is in your best interest.\r\n\r\nEnd of Treatment Visit:\r\n\r\nWithin 4 weeks after the last dose of study drugs, you will have an end-of-treatment visit. At this visit, the following tests and procedures will be performed:\r\n\r\nYou will have a physical exam, including measurement of your weight and vital signs.\r\nYou will have a pelvic exam.\r\nYour performance status will be recorded.\r\nBlood (about 2 tablespoons) will be drawn for routine tests, including checking your liver and kidneys and measuring the levels of sugar in your blood, and levels of fat in your blood.\r\nYou will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.\r\nIf the disease is in your chest, you will have chest CT and/or MRI scan to check the status of the disease.\r\nYour pills will be counted and any unused study drug will be returned.\r\nLong Term Follow-up:\r\n\r\nAfter you are off study, you will be followed by your doctor on a regular basis. How often these visits occur are up to you and your doctor. The following tests and procedures will be performed:\r\n\r\nYou will have a physical exam, including measurement of your weight and vital signs.\r\nYou will have a pelvic exam.\r\nYour performance status will be recorded.\r\nYou will be asked if you have experienced any intolerable side effects.\r\nYou will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.\r\nIf the disease is in your chest, you will have chest CT and/or MRI scan to check the status of the disease.\r\nThis is an investigational study. Everolimus is not FDA approved or commercially available. At this time, everolimus is only being used in research. Letrozole is FDA approved and commercially available for the treatment of breast cancer and ovarian cancer. The combination of everolimus and letrozole in this study for the treatment of endometrial cancer is also investigational. Up to 42 patients will take part in the multicenter study. Up to 42 will be enrolled at MD Anderson.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients must have signed an approved informed consent.\r\nHistologically confirmed endometrial cancer (endometrioid, serous, or clear cell, or mixed histology; any grade) which is considered progressive or recurrent.\r\nPatients may have failed no more than two prior chemotherapeutic regimens for recurrent or advanced disease (including adjuvant therapy). Chemotherapy administered in conjunction with radiation as a radio-sensitizer is not counted as a prior treatment for recurrent or advanced disease.\r\nAll patients must have measurable disease as defined by RECIST 1.1.\r\nPatients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST. Tumors within a previously irradiated field will be designated as "non-target" lesions, unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.\r\nPatients must have a Zubrod performance status of 0, 1, or 2.\r\nPatients must not be of child bearing potential. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal for greater than 12 months. Patients in whom ovaries are present and were not previously menopausal at the time of hysterectomy, should have a serum estradiol < 10 pg/mL to confirm ovarian senescence.\r\nPatients must have a pretreatment granulocyte count (i.e., segmented neutrophils + bands) of >1,500/Fl, a hemoglobin level of >/=9gm/dL and a platelet count of >100,000/Fl. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines.\r\nPatients must have an adequate renal function of >50cc/min as documented by the Cockcroft Gault creatinine clearance formula: Estimated GFR = (140 - age) x (weight kg) divided by 72 x serum Creatinine (non-IDMS) x 0.85 (female)\r\nPatients must have adequate hepatic function as documented by a serum bilirubin </=2.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor. Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.\r\nAlanine aminotransferase (SGPT) must be </= 3x institutional upper limit of normal unless the liver is involved with tumor, in that case, the alanine aminotransferase must be </= 5 x institutional upper limit of normal.\r\nPrior to beginning therapy, at least 4 weeks must have elapsed since prior chemotherapy, surgery, radiation therapy, hormonal therapy or investigational therapy. Patients receiving palliative radiation therapy are exempt from the 4 week waiting period.\r\nBaseline lipid levels (triglycerides, cholesterol) must be </= grade 1. Patients are allowed to be on lipid lowering drugs.\r\nPatients must be >/= 18 years of age.'}
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{'Arm - Disease - Stage of Cancer': 'Advanced'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05260671
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{'Official Title': 'An Exploratory Clinical Study to Evaluate the Efficacy and Safety of Penpulimab in Combination With Cetuximab as First-line Treatment in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/MSCCHN)', 'Brief Summary': 'This trial is a multicenter, prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of Penpulimab injection combined with cetuximab in the first-line treatment of recurrent/metastatic squamous cell carcinoma of the head and neck', 'Condition': 'Head and Neck Neoplasms\r\nRecurrent Disease\r\nMetastatic Cancer', 'Detailed Description': "Based on the apparent efficacy and favorable safety profile of previous PD-1 and cetuximab combination therapy, Penpulimab (PD-1 antibody) combined with cetuximab in the first-line treatment of patients with recurrent/metastatic SCCHN are used to assess the efficacy and safety of the regimen. Among them, Penpulimab (PD-1 antibody) is approved for adult patients with relapsed or refractory classical Hodgkin's lymphoma who have received at least second-line systemic chemotherapy in China. Cetuximab is approved in China for first-line treatment of recurrent/metastatic SCCHN in combination with chemotherapeutic drugs platinum and fluorouracil.\r\n\r\nThis study plans to enroll 48 patients with untreated recurrent/metastatic squamous cell carcinoma of the head and neck who will receive Penpulimab injection combined with cetuximab. Cetuximab 500 mg/m2 without PD-1 drugs for 14 days prior to Cycle 1. Cetuximab Injection 500 mg/m2 and Penpulimab Injection 200 mg are intravenously infused on Day 1 (D1) of Cycle 1, with 2 weeks (14 days) as a cycle. Penpulimab will be administered for no more than 96 weeks (48 cycles), and cetuximab will be administered until disease progression, unacceptable toxicity, or withdrawal decision by the subject.", 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nAge: ≥ 18 years, male or female;\r\nHistologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx) (SCCHN);\r\nRecurrent/metastatic SCCHN not suitable for local treatment such as surgery or radiotherapy in the opinion of the investigator;\r\nAt least one measurable tumor lesion according to RECIST 1.1 criteria;\r\nThe tumor expresses PD-L1, with a comprehensive positive score CPS ≥ 1;\r\nEastern Cooperative Oncology Group (ECOG) PS: 0-1\r\nExpected survival ≥ 3 months;\r\nNormal function of major organs, meeting the following criteria: blood routine examination criteria must be met: (no blood transfusion within 14 days before screening) 1) HB ≥ 90 g/L; 2) ANC ≥ 1.5 × 109/L; 3) PLT ≥ 75 × 109/L; biochemistry: (without transfusion or blood product within 14 days before screening) 1) BIL ≤ 1.5 × upper limit of normal (ULN) (≤ 3 × ULN for patients with Gilbert's syndrome); 2) ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastasis); 3) Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50ml/min (Cockcroft-Gault formula); 4) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN; left ventricular ejection fraction (LVEF) ≥ 50% assessed by cardiac Doppler ultrasound;\r\nWomen of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and are willing to use reliable contraception during the trial and must be non-lactating patients; male subjects must use reliable contraception from the start of treatment to 6 months after the last dose;\r\nThe subjects voluntarily join the study, sign the ICF, have good compliance, and cooperate in the follow-up"}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT03400332
|
{'Official Title': 'A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers', 'Brief Summary': 'The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.', 'Condition': 'Cancer\r\nMelanoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\r\nAt least 1 lesion accessible for biopsy\r\nEastern Cooperative Oncology Group Performance Status of 0 or 1'}
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{'Arm - Disease - Stage of Cancer': 'Advanced, Metastatic'}
| 0
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03400332
|
{'Official Title': 'A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers', 'Brief Summary': 'The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.', 'Condition': 'Cancer\r\nMelanoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\r\nAt least 1 lesion accessible for biopsy\r\nEastern Cooperative Oncology Group Performance Status of 0 or 1'}
|
{'Arm - Disease - Stage of Cancer': 'Advanced, Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03400332
|
{'Official Title': 'A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers', 'Brief Summary': 'The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.', 'Condition': 'Cancer\r\nMelanoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\r\nAt least 1 lesion accessible for biopsy\r\nEastern Cooperative Oncology Group Performance Status of 0 or 1'}
|
{'Arm - Disease - Stage of Cancer': 'Advanced, Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03400332
|
{'Official Title': 'A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers', 'Brief Summary': 'The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.', 'Condition': 'Cancer\r\nMelanoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\r\nAt least 1 lesion accessible for biopsy\r\nEastern Cooperative Oncology Group Performance Status of 0 or 1'}
|
{'Arm - Disease - Stage of Cancer': 'Advanced, Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03400332
|
{'Official Title': 'A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers', 'Brief Summary': 'The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.', 'Condition': 'Cancer\r\nMelanoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\r\nAt least 1 lesion accessible for biopsy\r\nEastern Cooperative Oncology Group Performance Status of 0 or 1'}
|
{'Arm - Disease - Stage of Cancer': 'Advanced, Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03924869
|
{'Official Title': 'A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).\r\n\r\nThe primary study hypotheses are:\r\n\r\nSBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution), and\r\nSBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.', 'Condition': 'Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nHas previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan. Participants with pericardium invasion, >2 nodules or 2 nodules that cannot be treated in one field (>2 cm apart and/or total planned target volume [PTV] >163 cc) and diaphragm elevation suggestive of phrenic nerve invasion are excluded\r\nCannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board. Medically operable participants who decide to treat with stereotactic body radiotherapy (SBRT) as definitive therapy rather than surgery are also eligible, if patient's unwillingness to undergo surgical resection is clearly documented\r\nHas a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\r\nIs able to receive SBRT and does not have an ultra-centrally located tumor\r\nHas adequate organ function within 7 days prior to the start of study treatment\r\nA female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP and uses contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose\r\nMale participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of radiotherapy: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per study protocol, unless confirmed to be azoospermic\r\nHas a radiation therapy plan approved by the central radiation therapy quality assurance vendor"}
|
{'Arm - Disease - Stage of Cancer': 'Stage I, Stage II '}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03924869
|
{'Official Title': 'A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).\r\n\r\nThe primary study hypotheses are:\r\n\r\nSBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution), and\r\nSBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.', 'Condition': 'Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nHas previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan. Participants with pericardium invasion, >2 nodules or 2 nodules that cannot be treated in one field (>2 cm apart and/or total planned target volume [PTV] >163 cc) and diaphragm elevation suggestive of phrenic nerve invasion are excluded\r\nCannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board. Medically operable participants who decide to treat with stereotactic body radiotherapy (SBRT) as definitive therapy rather than surgery are also eligible, if patient's unwillingness to undergo surgical resection is clearly documented\r\nHas a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\r\nIs able to receive SBRT and does not have an ultra-centrally located tumor\r\nHas adequate organ function within 7 days prior to the start of study treatment\r\nA female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP and uses contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose\r\nMale participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of radiotherapy: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per study protocol, unless confirmed to be azoospermic\r\nHas a radiation therapy plan approved by the central radiation therapy quality assurance vendor"}
|
{'Arm - Disease - Stage of Cancer': 'Stage I, Stage II '}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT02667587
|
{'Official Title': 'A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma', 'Brief Summary': 'The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.', 'Condition': 'Brain Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nMales and Females, age ≥ 18 years old\nNewly diagnosed brain cancer or tumor called glioblastoma or GBM\nKarnofsky performance status of ≥ 70 (able to take care of self)\nSubstantial recovery from surgery resection\nTumor test result shows MGMT methylated or indeterminate tumor subtype'}
|
{'Arm - Disease - Stage of Cancer': 'Newly Diagnosed '}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT02667587
|
{'Official Title': 'A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma', 'Brief Summary': 'The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.', 'Condition': 'Brain Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMales and Females, age ≥ 18 years old\r\nNewly diagnosed brain cancer or tumor called glioblastoma or GBM\r\nKarnofsky performance status of ≥ 70 (able to take care of self)\r\nSubstantial recovery from surgery resection\r\nTumor test result shows MGMT methylated or indeterminate tumor subtype'}
|
{'Arm - Disease - Stage of Cancer': 'Newly Diagnosed '}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT04982237
|
{'Official Title': 'A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'This is A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nsigns the written informed consent form.\r\nWomen aged ≥ 18 and ≤ 75 years.\r\nECOG of 0 or 1.\r\nLife expectancy ≥ 3 months.\r\nHistologically or cytologically confirmed cervical cancer, not amenable to curative surgery or concurrent chemoradiotherapy.\r\n\r\nThe histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma;\r\nNo prior systemic therapy for persistent, recurrent or metastatic ([FIGO] Stage IVB) disease.\r\nAt least one measurable tumor lesion per RECIST v1.1; lesions at sites previously treated with radiotherapy or other loco-regional therapy are not considered as target lesions unless the lesion has unequivocal progression or the biopsy is obtained to confirm maligancy.\r\nAll subjects must provide archival tumor tissue samples within 2 years prior to randomization,or fresh tumor tissue samples obtained by biopsy.\r\nSubjects must have adequate organ function as assessed in the laboratory tests.\r\nFemale subjects of childbearing potential must have a negative serum pregnancy test prior to the first dose. If a female subject of childbearing potential must use acceptable effective methods of contraception from screening and must agree to continue these precautions until 120 days after the last dose of study drug.'}
|
{'Arm - Disease - Stage of Cancer': 'Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT04982237
|
{'Official Title': 'A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'This is A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nsigns the written informed consent form.\r\nWomen aged ≥ 18 and ≤ 75 years.\r\nECOG of 0 or 1.\r\nLife expectancy ≥ 3 months.\r\nHistologically or cytologically confirmed cervical cancer, not amenable to curative surgery or concurrent chemoradiotherapy.\r\n\r\nThe histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma;\r\nNo prior systemic therapy for persistent, recurrent or metastatic ([FIGO] Stage IVB) disease.\r\nAt least one measurable tumor lesion per RECIST v1.1; lesions at sites previously treated with radiotherapy or other loco-regional therapy are not considered as target lesions unless the lesion has unequivocal progression or the biopsy is obtained to confirm maligancy.\r\nAll subjects must provide archival tumor tissue samples within 2 years prior to randomization,or fresh tumor tissue samples obtained by biopsy.\r\nSubjects must have adequate organ function as assessed in the laboratory tests.\r\nFemale subjects of childbearing potential must have a negative serum pregnancy test prior to the first dose. If a female subject of childbearing potential must use acceptable effective methods of contraception from screening and must agree to continue these precautions until 120 days after the last dose of study drug.'}
|
{'Arm - Disease - Stage of Cancer': 'Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03631199
|
{'Official Title': 'A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)', 'Brief Summary': 'This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects.\r\n\r\nThe study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.', 'Condition': 'Non-small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion criteria:\r\n\r\nHistologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting\r\nKnown PD-L1 status determined by a Novartis designated central laboratory. A newly obtained tissue biopsy or an archival biopsy (block or slides) is required for PD-L1 determination (PD-L1 IHC 22C3 pharmDx assay), prior to study randomization. Note: For the safety run-in part, known PD-L1 status is not required.\r\nEastern Cooperative oncology group (ECOG) performance status of 0 or 1.\r\nAt least 1 measurable lesion by RECIST 1.1'}
|
{'Arm - Disease - Stage of Cancer': 'Stage IIIB or Stage IV, Advanced or Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03631199
|
{'Official Title': 'A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)', 'Brief Summary': 'This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects.\r\n\r\nThe study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.', 'Condition': 'Non-small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion criteria:\n\nHistologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting\nKnown PD-L1 status determined by a Novartis designated central laboratory. A newly obtained tissue biopsy or an archival biopsy (block or slides) is required for PD-L1 determination (PD-L1 IHC 22C3 pharmDx assay), prior to study randomization. Note: For the safety run-in part, known PD-L1 status is not required.\nEastern Cooperative oncology group (ECOG) performance status of 0 or 1.\nAt least 1 measurable lesion by RECIST 1.1'}
|
{'Arm - Disease - Stage of Cancer': 'Stage IIIB or Stage IV, Advanced or Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05052801
|
{'Official Title': 'A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression', 'Brief Summary': 'The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)', 'Condition': 'Gastric Cancer\nGastroesophageal Junction Adenocarcinoma', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\n\nAdults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy\nFibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy\nEastern Cooperative Oncology Group (ECOG) less than or equal to 1\nMeasurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1\nParticipant has no contraindications to mFOLFOX6 chemotherapy\nAdequate organ and bone marrow function:\n\nabsolute neutrophil count greater than or equal to 1.5 times 10^9/L\nplatelet count greater than or equal to 100 times 10^9/L\nhemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment\naspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)\ncalculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)\ninternational normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment"}
|
{'Arm - Disease - Stage of Cancer': 'Locally Advanced, Metastatic'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05052801
|
{'Official Title': 'A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression', 'Brief Summary': 'The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)', 'Condition': 'Gastric Cancer\nGastroesophageal Junction Adenocarcinoma', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\n\nAdults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy\nFibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy\nEastern Cooperative Oncology Group (ECOG) less than or equal to 1\nMeasurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1\nParticipant has no contraindications to mFOLFOX6 chemotherapy\nAdequate organ and bone marrow function:\n\nabsolute neutrophil count greater than or equal to 1.5 times 10^9/L\nplatelet count greater than or equal to 100 times 10^9/L\nhemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment\naspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)\ncalculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)\ninternational normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment"}
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{'Arm - Disease - Stage of Cancer': 'Locally Advanced, Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05029102
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{'Official Title': 'TAS-102 Combined With Anlotinib in Patients With Metastatic Gastric Cancer Refractory to Standard Treatments (THALIA): a Prospective Single-arm Phase II Study', 'Brief Summary': 'To determine the efficacy and safety of TAS-102 and Anlotinib in patients with metastatic gastric cancer who had been treated with ≥ 2 lines of prior standard chemotherapy', 'Condition': 'Gastric Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nAge ≥ 18 years, ≤75 years\r\nHistologically confirmed gastric cancer with distant metastasis\r\nECOG 0-1\r\nProgression on ≥ 2 lines of prior standard chemotherapy\r\nPatients can swallow pills normally\r\nExpected overall survival ≥6 months\r\nBlood routine: no blood transfusion or blood products usage within 14 days, G-CSF or other hematopoietic stimulator was not used. WBC counts > 3000/µl，Absolute neutrophil count (ANC) ≥ 1500 cells/µl，Platelet count ≥ 100,000/µl，Hemoglobin ≥ 9.0 g/dL.\r\nAST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)，Serum bilirubin ≤ 1.5 x ULN，creatinine<ULN\r\nProthrombin time (PT), international standard ratio (INR) ≤1.5 × ULN\r\nWomen of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment;\r\nInformed consent has been signed.'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05481463
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{'Official Title': 'A Open-label, Single-arm, Single-center, Phase II Clinical Study of Surufatinib Combined With TAS-102 in Third-line and Later-line Therapy of Patients With Advanced Pancreatic Cancer', 'Brief Summary': 'This is a single-center, single-arm, open-label, phase 2 clinical study, to explore the efficacy and safety of surufatinib combined with TAS-102 in third-line and later-line therapy of patients with advanced pancreatic cancer', 'Condition': 'Pancreatic Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nInformed consent has been signed\r\nHistologically or cytologically confirmed unresectable, locally advanced or metastatic pancreatic cancer\r\nAge ≥ 18 years, ≤75 years, male or female\r\nECOG PS：0-1, expected overall survival ≥12 months\r\nPatients who have previously received at least two systemic therapies for locally advanced or metastatic pancreatic cancer; patients with BRCA1/2 germline mutations have previously received platinum-containing regimens\r\nPatients must have at least one measurable liver metastases (RECIST 1.1)\r\nNo serious organic diseases of the heart, lungs, brain and other organs\r\nPatients must have adequate organ and bone marrow function\r\nWomen of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration'}
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{'Arm - Disease - Stage of Cancer': 'Locally advanced or metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05672316
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{'Official Title': 'A Phase I/II Trial of Botensilimab, Balstilimab and Regorafenib (BBR) in Patients With Microsatellite Stable (MSS) Metastatic Colorectal Cancer Who Progressed on Prior Chemotherapy', 'Brief Summary': "This phase I/II trial tests how well botensilimab, balstilimab, and regorafenib works in treating patients with microsatellite stable colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who have progressed on prior chemotherapy. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Regorafenib binds to and inhibits growth factor receptors, which may inhibit the growth of new blood vessels that tumors need to grow. Giving botensilimab, balstilimab, and regorafenib in combination may work better in treating patients with metastatic colorectal cancer than giving these drugs alone.", 'Condition': 'Advanced Colorectal Adenocarcinoma\nAdvanced Microsatellite Stable Colorectal Carcinoma\nMetastatic Colorectal Adenocarcinoma\nMetastatic Microsatellite Stable Colorectal Carcinoma\nStage III Colorectal Cancer AJCC v8\nStage IV Colorectal Cancer AJCC v8', 'Detailed Description': 'PRIMARY OBJECTIVES:\n\nI. To identify the recommended phase 2 dose (RP2D) of botensilimab, balstilimab, and regorafenib (BBR) in patients with chemotherapy-resistant microsatellite stable (MSS) metastatic colorectal cancer (MSS mCRC). (Phase I) II. To estimate the overall response rate (ORR) of botensilimab, balstilimab, and regorafenib in patients with chemotherapy-resistant MSS mCRC, with and without liver metastatic disease. (Phase II)\n\nSECONDARY OBJECTIVES:\n\nI. Describe the safety of botensilimab, balstilimab, and regorafenib at all evaluable dose levels. (Phase I) II. Describe the efficacy of BBR in terms of ORR, progression free survival (PFS) and overall survival (OS). (Phase I) III. To evaluate the safety/feasibility of botensilimab, balstilimab, and regorafenib through the assessment of adverse events. (Phase II) IV. Estimate the PFS, OS and duration of response (DOR). (Phase II)\n\nCORRELATIVE OBJECTIVES:\n\nI. Evaluate potential circulating biomarkers of response, resistance, activity, and toxicity. (Phase I/II) II. Correlate baseline molecular biomarkers (RAS, BRAF, TMB, and PD-L1 if available), with overall outcome. (Phase I/II)\n\nOUTLINE: This is a phase I, dose-escalation study of botensilimab followed by a phase II study.\n\nPatients receive botensilimab intravenously (IV), balstilimab IV, and regorafenib orally (PO) on study. Patients also undergo computed tomography (CT) and collection of blood throughout the study.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nDocumented informed consent of the participant and/or legally authorized representative.\n\nAssent, when appropriate, will be obtained per institutional guidelines\nAge: >= 18 years\nEastern Cooperative Oncology Group (ECOG) =< 1\nLife expectancy >= 3 months\nAble to swallow and absorb oral tablets\nHistological or cytological confirmed advanced, metastatic, or progressive proficient mismatch repair (pMMR)/MSS adenocarcinoma of colon or rectum\n\nMicrosatellite status should be performed per local standard of practice (e.g., immunohistochemistry [IHC] and/or polymerase chain reaction [PCR], or next-generation sequencing). Only participants with pMMR/MSS mCRC are eligible\nPatients should have measurable metastatic disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines\nKnown extended RAS and BRAF status as per local standard of practice. TMB and PD-L1 status will be collected when available but not mandated for enrollment\nPatients must have progressed following exposure to all of the following agents:\n\nFluoropyrimidines (capecitabine or 5-FU)\nIrinotecan\nOxaliplatin\nAnti-EGFR therapy if RAS and BRAF wild type with left colon primary\nPatients must have evidence of progression on or after the last treatment received and within 6 months prior to study enrollment\n\nPatients who were intolerant to prior systemic chemotherapy regimens are eligible if there is documented evidence of clinically significant intolerance despite adequate supportive measures\nAdjuvant/neoadjuvant chemotherapy can be considered as one line of chemotherapy for advanced/metastatic disease if the participant had disease recurrence within 6 months of completion\nFor patients with liver metastatic disease, patients must have no more than 5 hepatic metastases at the time of enrollment\nPatients without liver metastatic disease should be either with no history of liver metastatic disease or with history of resected or ablated liver metastases without evidence of disease recurrence in the liver for at least 6 months before enrollment\nTotal bilirubin =< 1.5 x upper limit of normal (ULN) (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nAspartate aminotransferase (AST) =< 2.5 x ULN, unless presence of liver metastases for which =< 5 x ULN is allowed (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nAlanine aminotransferase (ALT) =< 2.5 x ULN, unless presence of liver metastases for which =< 5 x ULN is allowed (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nSerum creatinine =< 1.5 x ULN or creatinine clearance >= 40 mL/min (measured or calculated using the Cockcroft-Gault formula) (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nWhite blood cell (WBC) >= 2000/ul (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nHemoglobin >= 9 g/dl (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nAbsolute neutrophil count (ANC) >= 1500/ul (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nPlatelets >= 75,000/mm^3 (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nAlbumin >= 3.0 g/dl (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nWomen of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nAgreement by females and males of childbearing potential to use an effective method of birth control or abstain from sexual activity for the course of the study through at least 120 days after the last dose of protocol therapy\n\nFemales of non-childbearing potential defined as:\n\n>= 50 years of age and has not had menses for greater than 1 year\nAmenorrheic for >= 2 years without a hysterectomy and bilateral oophorectomy and a follicle stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation\nStatus is post-hysterectomy, bilateral oophorectomy, or tubal ligation'}
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{'Arm - Disease - Stage of Cancer': 'Advanced, Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT02257736
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{'Official Title': 'A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)', 'Brief Summary': 'The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of sperm]).', 'Condition': 'Prostatic Neoplasms', 'Detailed Description': "This is a randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know the treatment) placebo-controlled and multicenter (when more than 1 hospital or medical school team work on a medical research study) study to determine if participants with chemotherapy-naive mCRPC will benefit from the addition of apalutamide to AAP compared with AAP alone. The study consists of 3 phases: Screening phase; Treatment phase, and Follow-up phase. At the final analysis, the study will be unblinded. After the Independent Data Monitoring Committee (IDMC) review and the sponsor's subsequent decision participants will be offered to receive treatment either in the Open-Label Extension Phase or the Long-Term Extension Phase of study. Participants' safety will be monitored throughout the study.", 'Inclusion Criteria': 'Inclusion Criteria:\n\nAdenocarcinoma of the prostate\nMetastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). If lymph node metastasis is the only evidence of metastasis, it must be greater than or equal to (>=) 2 centimeter (cm) in the longest diameter\nCastration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of PSA, at least 1 week apart with the last androgen deprivation therapy (PSA) >= 2 nanogram per milliliters (ng/mL)\nParticipants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after the washout period\nProstate cancer progression documented by prostate-specific antigen (PSA) according to the Prostate Cancer Clinical Trials Working Group (PCWG2) or radiographic progression of soft tissue according to modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone according to PCWG2\nParticipants who cross-over from Prednisone alone to open-label apalutamide plus AAP should still be in the double-blind phase of the study, should be receiving AAP alone and should have ECOG 0-1-2.'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
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|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT02257736
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{'Official Title': 'A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)', 'Brief Summary': 'The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of sperm]).', 'Condition': 'Prostatic Neoplasms', 'Detailed Description': "This is a randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know the treatment) placebo-controlled and multicenter (when more than 1 hospital or medical school team work on a medical research study) study to determine if participants with chemotherapy-naive mCRPC will benefit from the addition of apalutamide to AAP compared with AAP alone. The study consists of 3 phases: Screening phase; Treatment phase, and Follow-up phase. At the final analysis, the study will be unblinded. After the Independent Data Monitoring Committee (IDMC) review and the sponsor's subsequent decision participants will be offered to receive treatment either in the Open-Label Extension Phase or the Long-Term Extension Phase of study. Participants' safety will be monitored throughout the study.", 'Inclusion Criteria': 'Inclusion Criteria:\n\nAdenocarcinoma of the prostate\nMetastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). If lymph node metastasis is the only evidence of metastasis, it must be greater than or equal to (>=) 2 centimeter (cm) in the longest diameter\nCastration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of PSA, at least 1 week apart with the last androgen deprivation therapy (PSA) >= 2 nanogram per milliliters (ng/mL)\nParticipants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after the washout period\nProstate cancer progression documented by prostate-specific antigen (PSA) according to the Prostate Cancer Clinical Trials Working Group (PCWG2) or radiographic progression of soft tissue according to modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone according to PCWG2\nParticipants who cross-over from Prednisone alone to open-label apalutamide plus AAP should still be in the double-blind phase of the study, should be receiving AAP alone and should have ECOG 0-1-2.'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05353257
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{'Official Title': 'A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer', 'Brief Summary': 'This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.', 'Condition': 'Limited-Stage Small Cell Lung Cancer', 'Detailed Description': 'Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio.\r\n\r\nArm A (Serplulimab arm): Serplulimab + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; Arm B (placebo arm): Placebo + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; The 4 stratification factors for randomization include: ECOG PS (0 or 1), staging (I/II or III), radiation fraction (bid or qd), and region (Asia or non-Asia).', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale or female, aged ≥18 years when signing the ICF.\r\nHistologically diagnosed with SCLC.\r\nDiagnosed with LS-SCLC (stage Ⅰ-Ⅲ of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses.\r\nMajor organs are functioning well.'}
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{'Arm - Disease - Stage of Cancer': 'Limited Stage, Stage I, Stage II, Stage III'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05353257
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{'Official Title': 'A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer', 'Brief Summary': 'This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.', 'Condition': 'Limited-Stage Small Cell Lung Cancer', 'Detailed Description': 'Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio.\r\n\r\nArm A (Serplulimab arm): Serplulimab + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; Arm B (placebo arm): Placebo + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; The 4 stratification factors for randomization include: ECOG PS (0 or 1), staging (I/II or III), radiation fraction (bid or qd), and region (Asia or non-Asia).', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale or female, aged ≥18 years when signing the ICF.\r\nHistologically diagnosed with SCLC.\r\nDiagnosed with LS-SCLC (stage Ⅰ-Ⅲ of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses.\r\nMajor organs are functioning well.'}
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{'Arm - Disease - Stage of Cancer': 'Limited Stage, Stage I, Stage II, Stage III'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05328908
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{'Official Title': 'A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants With Later-lines of Metastatic Colorectal Cancer', 'Brief Summary': 'The purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab FDC, also referred to as BMS-986213) for the treatment of non-microsatellite instability high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.', 'Condition': 'Colorectal Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry\r\nParticipants must have:\r\n\r\nprogressed during or within approximately 3 months following the last administration of approved standard therapies (at least 1, but not more than 4 prior lines of therapies in the metastatic setting), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if RAS wild-type), if available in the respective country, or;\r\nbeen intolerant to prior systemic chemotherapy regimens if there is documented evidence of clinically significant intolerance despite adequate supportive measures\r\nMust have sufficient tumor tissue & evaluable PD-L1 expression to meet the study requirements\r\nMust have measurable disease per RECIST v1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05328908
|
{'Official Title': 'A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants With Later-lines of Metastatic Colorectal Cancer', 'Brief Summary': 'The purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab FDC, also referred to as BMS-986213) for the treatment of non-microsatellite instability high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.', 'Condition': 'Colorectal Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry\r\nParticipants must have:\r\n\r\nprogressed during or within approximately 3 months following the last administration of approved standard therapies (at least 1, but not more than 4 prior lines of therapies in the metastatic setting), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if RAS wild-type), if available in the respective country, or;\r\nbeen intolerant to prior systemic chemotherapy regimens if there is documented evidence of clinically significant intolerance despite adequate supportive measures\r\nMust have sufficient tumor tissue & evaluable PD-L1 expression to meet the study requirements\r\nMust have measurable disease per RECIST v1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
| 0
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT03959293
|
{'Official Title': 'A Randomized Phase II Study Evaluating FOLFIRI + Durvalumab vs FOLFIRI + Durvalumab and Tremelimumab in Second-line Treatment of Patients With Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma', 'Brief Summary': 'Gastric adenocarcinoma is the 4th most frequent cancer and the 2nd leading cause of cancer mortality. Most of the patients have metastatic, locally advanced or recurrent unresectable disease. So, systemic treatment remains an important issue especially since chemotherapy improves survival and quality of life (compared to best supportive care alone).\n\nSecond-line chemotherapy-based treatment improves overall survival (OS) as compared to best supportive care alone in patients with an acceptable general condition (performance status 0-2). Indeed, with docetaxel monotherapy there was a significant difference in overall survival for the chemotherapy arm with a median of 5.2 versus 3.6 months in best supportive care alone arm (HR=0.67, p=0.01). Irinotecan monotherapy also significantly improves overall survival compared to supportive care alone in a phase III study (4.0 versus 2.4 months; HR=0.48, 95%CI 0.25-0.92; p=0.012).\n\nBased on a phase III trial FOLFIRI (5-FU plus irinotecan) is one most used regimen in second-line in European countries, especially in France. FFCD 0307 trial, a phase III comparing FOLFIRI-ECX (epirubicin-cisplatin-capecitabine) to the reverse sequence (ECX-FOLFIRI), showed that both sequences are possible.\n\nPreliminary results in metastatic gastric cancer with anti-PD1 mAbs are highly promising. In a trial with pembrolizumab, only PD-L1 positive tumors were eligible to the treatment with a cut off at 1%. Thirty-nine patients were enrolled and 67% had received at least two prior chemotherapy regimens. The overall response rate was 22%. The median PFS and OS were 1.9 months and 11.4 months, respectively. KEYNOTE-059 Phase 2 multicohort study with pembrolizumab monotherapy in advanced gastric cancer treatment has been presented at ASCO 2017 meeting. Among 259 patients included in the trial response rate was 11.6%. OS was 5.6 months. Response rates were 15.5% in PDL1+ tumors versus 6.4% in PDL1- tumors and 57.1% in MSI tumors versus 9% in MSS tumors. Up until now, overlap between microsatellite instability and PD-L1 expression is unknown in gastric cancer. An anti-PD-L1 mAb (avelumab) was evaluated in a phase Ib expansion study (n=20, Japanese patients), with 15% of objective response rate and 11.9 weeks for progression-free survival. A second cohort with avelumab included 55 patients for maintenance therapy after first-line chemotherapy, with 7.3% of objective response rate and 14 weeks of PFS. Phase I/II CheckMate-032 evaluated nivolumab (anti-PD-1) ± ipilimumab (anti-CTLA4) at different doses in advanced gastric cancer (17). The overall response rate was between 8% to 24% and the median OS between 4.8 to 6.9 months according to treatment arm.\n\nOthers anti-PD1/anti-PD-L1/anti-CTLA4 mAbs are also currently under investigation in gastric cancer alone or in combination with chemotherapy. Nevertheless, up until now there is no published data concerning ICI plus chemotherapy in gastric cancer. The present randomized multicentric non-comparative phase II study aimed to assess the rate of patients alive and without progression at 4 months with advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, pre-treated with fluoropyrimidine + platinum +/- taxane, with two arms Folfiri plus durvalumab versus Folfiri plus durvalumab plus tremelimumab. Indeed, most patients in the French multicentric first-line GASTFOX trial (506 patients planned between 2017 and 2020) can be included in the second-line setting in the DURIGAST trial. Due to the lack of data concerning Folfiri plus durvalumab plus tremelimumab combination, a safety run-in phase will be performed at the beginning of the DURIGAST trial.', 'Condition': 'Gastric Adenocarcinoma\nGastric Cancer', 'Detailed Description': 'Gastric adenocarcinoma is the fourth most frequent cancer and the second leading cause of cancer mortality. Advanced gastric adenocarcinoma has a poor prognosis with short overall survival (ranging from 10% to 15% at 5-years) even after surgical complete resection and despite the progress in therapeutic approaches. Most of the patients have metastatic, locally advanced or recurrent unresectable disease. So, systemic treatment remains an important issue especially since chemotherapy improves survival and quality of life (compared to best supportive care alone). First-line chemotherapy depends on HER2 status, which also influenced overall survival (14 months for HER2 positive versus 10 months for HER2 negative tumors). In HER2 negative tumors standard first-line regimen is a doublet of fluoropyrimidine (5-fluorouracil or capecitabine) plus a platinum salt (cisplatin or oxaliplatin). 5-fluorouracil (5-FU) and capecitabine as also cisplatin and oxaliplatin have similar efficacy but different toxicities.\n\nIn patients whose tumor overexpresses the HER2 receptor adding trastuzumab to fluoropyrimidine/cisplatin regimen increased overall survival compared to chemotherapy alone. In HER2 negative tumors the addition of docetaxel to cisplatin/fluoropyrimidine regimen increased overall survival but its use remains limited in clinical practice because of its high toxicity. Preliminary results demonstrated a high efficacy with less toxicities of docetaxel-oxaliplatin-fluoropyrimidine combination, also called TFOX/FLOT regimen. Indeed, in France a large phase III trial comparing TFOX versus FOLFOX in first-line treatment of patients with advanced gastric or gastro-oesophageal junction adenocarcinoma is ongoing (GASTFOX, trial NCT03006432). Primary endpoint is progression-free survival (PFS) and 506 patients are planned between 2017 and 2020 (actually at the date of January 30, 2018, 65 patients are included).\n\nSecond-line chemotherapy improves overall survival (OS) as compared to best supportive care alone in patients with an acceptable general condition (performance status 0-2). Indeed, with docetaxel monotherapy there was a significant difference in overall survival for the chemotherapy arm with a median of 5.2 versus 3.6 months in best supportive care alone arm (HR=0.67, p=0.01). Weekly paclitaxel monotherapy is also used because of its good efficacy-toxicity ratio. Irinotecan monotherapy also significantly improves overall survival compared to supportive care alone in a phase III study (4.0 versus 2.4 months; HR=0.48, 95%CI 0.25-0.92; p=0.012). Recently ramucirumab monotherapy demonstrated its efficacy on overall survival in a randomized, placebo-controlled second-line metastatic study. In a randomized phase 3 trial ramucirumab also showed its efficacy in combination with paclitaxel versus paclitaxel monotherapy with a median overall survival of 9.6 versus 7.4 months, respectively (p=0.017; HR=0.81). However, the "amelioration du service medical rendu" (ASMR) assessed by the French "Haute Autorité de Santé" (HAS) consider an insufficient benefit to a reimbursement of ramucirumab in France. The HAS gave a moderate ASMR opinion (ASMR IV).\n\nDocetaxel is more and more frequently used in first-line chemotherapy then in this setting taxane (alone or combined with others drugs) cannot be used as second-line regimen. Indeed, based on a phase III trial FOLFIRI (5-FU plus irinotecan) is one most used regimen in second-line in European countries, especially in France. FFCD 0307 trial, a phase III comparing FOLFIRI-ECX (epirubicin-cisplatin-capecitabine) to the reverse sequence (ECX-FOLFIRI), showed that both sequences are possible.\n\nHuman tumors tend to activate the immune system regulatory checkpoints as a means of escaping immunosurveillance. For instance, interaction between PD1 (Program Death 1) and PD-L1 (Program Death 1 ligand) will lead the activated T cell to a state of anergy. PD-L1 is up regulated on a wide range of cancers. Anti-PD1 and anti-PD-L1 monoclonal antibodies (mAbs), called immune checkpoint inhibitors (ICIs), have consequently been designed to restore T cell activity. Others ICIs are investigated, notably cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors. CTLA-4 transmits an inhibitory signal to T cells to prevent early excessive T cell activation. CTLA4 blockade may stimulate a more robust antitumor response by sustaining activation and proliferation of T lymphocytes and may overcome immune suppression mediated by regulatory T cells. ICIs have been recently tested in many cancers with promising results, especially in tumors with microsatellite instability (MSI) and/or PD-L1 overexpression.\n\nPreliminary results in metastatic gastric cancer with anti-PD1 mAbs are highly promising. In a trial with pembrolizumab, only PD-L1 positive tumors were eligible to the treatment with a cut off at 1%. Thirty-nine patients were enrolled and 67% had received at least two prior chemotherapy regimens. The overall response rate was 22%. The median PFS and OS were 1.9 months and 11.4 months, respectively. KEYNOTE-059 Phase 2 multicohort study with pembrolizumab monotherapy in advanced gastric cancer treatment has been presented at ASCO 2017 meeting. Among 259 patients included in the trial response rate was 11.6%. OS was 5.6 months. Response rates were 15.5% in PDL1+ tumors versus 6.4% in PDL1- tumors and 57.1% in MSI tumors versus 9% in MSS tumors. Up until now, overlap between microsatellite instability and PD-L1 expression is unknown in gastric cancer. An anti-PD-L1 mAb (avelumab) was evaluated in a phase Ib expansion study (n=20, Japanese patients), with 15% of objective response rate and 11.9 weeks for progression-free survival. A second cohort with avelumab included 55 patients for maintenance therapy after first-line chemotherapy, with 7.3% of objective response rate and 14 weeks of PFS. Phase I/II CheckMate-032 evaluated nivolumab (anti-PD-1) ± ipilimumab (anti-CTLA4) at different doses in advanced gastric cancer (17). The overall response rate was between 8% to 24% and the median OS between 4.8 to 6.9 months according to treatment arm.\n\nOthers anti-PD1/anti-PD-L1/anti-CTLA4 mAbs are also currently under investigation in gastric cancer alone or in combination with chemotherapy. Nevertheless, up until now there is no published data concerning ICI plus chemotherapy in gastric cancer. Finally, immunogenic cell death induced by chemotherapy may enhance efficacy of ICIs. Durvalumab (MEDI4736) is a human monoclonal antibody directed against PD-L1 in development for the treatment of many cancers. A phase I study included 16 patients with advanced gastric cancer and the objective response rate was 25%. Tremelimumab is a fully human monoclonal antibody against CTLA-4. Durvalumab plus tremelimumab combination showed a manageable tolerability profile, with antitumour activity irrespective of PD-L1 status in non-small cell lung cancer (NSCLC). Durvalumab alone or combined with tremelimumab is evaluated in phase III studies in NSCLC (e.g NEPTUNE and MYSTIC), small cell lung cancer (CASPIAN), hepatocellular carcinoma (HIMALAYA), bladder cancer (DANUBE) and head and neck cancer (EAGLE and KESTREL).\n\nConcerning safety of anti-PD1 plus anti-CTLA4 combination, in the randomized phase I/II CheckMate-032 study, that included 160 patients, there was no unexpected toxicity signal. Grade 3 and 4 treatment-related adverse events were 17%, 47%, and 27%, respectively. These rates of grade 3 and 4 treatment-related adverse events are those usually found with the anti-PD1 plus anti-CTLA4 combination in other tumors, observed approximately in 40% of patients. Up until now, there is no published data concerning combination of ICIs plus irinotecan. Nevertheless, in all trial combining chemotherapy plus anti-PD1 and/or anti-CTLA4 chemotherapy drugs were used at full-dose (5FU, oxaliplatin, cisplatin…). An Italian trial just started and combined full-dose FOLFOXIRI (5-FU 3200 mg/m2 plus irinotecan 165 mg/m2 and oxaliplatin 85 mg/m2) with bevacizumab (5 mg/kg) and atezolizumab (anti-PD-L1, 840 mg) in metastatic colorectal cancers as first-line treatment. FOLFOXIRI is a triplet chemotherapy more "toxic" than FOLFIRI doublet chemotherapy and this trial is a randomized phase II (FOLFOXIRI plus bevacizumab and atezolizumab versus FOLFOXIRI plus bevacizumab). There is, however, a preliminary safety phase in 6 patients, once they have all received at least 2 cycles of treatment, the latter being administered at full dose (AtezoTRIBE trial, NCT03721653).\n\nThe present randomized multicentric non-comparative phase II study aimed to assess the rate of patients alive and without progression at 4 months with advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, pre-treated with fluoropyrimidine + platinum +/- taxane, with two arms Folfiri plus durvalumab versus Folfiri plus durvalumab plus tremelimumab. Indeed, most patients in the French multicentric first-line GASTFOX trial (506 patients planned between 2017 and 2020) can be included in the second-line setting in the DURIGAST trial. Due to the lack of data concerning Folfiri plus durvalumab plus tremelimumab combination, a safety run-in phase will be performed at the beginning of the DURIGAST trial.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥ 18 years.\nBody weight > 30kg.\nHistologically proven advanced-stage unresectable adenocarcinoma of the stomach or the GEJ (Siewert II or III).\nKnown MSS/MSI status or tumor tissue available (frozen or paraffin-embedded, primary tumors or metastases) in order to allow determination of MSS/MSI status. The investigator needs to ensure that tumor tissues will be sent after patient randomization.\nFailure to platinium-based 1st line therapy with or without trastuzumab, or early recurrent disease after surgery with neo-adjuvant and/or adjuvant platinium-based chemotherapy (within 6 months of the end of chemotherapy) or progression during neo-adjuvant and/or adjuvant platinium-based chemotherapy.\nEligible for a second-line treatment with irinotecan and 5-FU.\nMeasurable or non-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\nEastern Cooperative Oncology Group (ECOG) performance status 0-1.\nAdequate organ function: ANC ≥ 1.5 x 109/L, haemoglobin ≥ 9 g/dL, platelets ≥ 100 x 109/L, AST/ALT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastase(s)), GGT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastase(s)), bilirubin ≤ 1.5 x ULN, creatinin clearance > 40 mL/min (MDRD).\nEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.\nMan and woman who childbearing potential agrees to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 6 months after the last treatment intake.\nPatient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures performed.'}
|
{'Arm - Disease - Stage of Cancer': 'Advanced'}
| 0
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03959293
|
{'Official Title': 'A Randomized Phase II Study Evaluating FOLFIRI + Durvalumab vs FOLFIRI + Durvalumab and Tremelimumab in Second-line Treatment of Patients With Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma\n', 'Brief Summary': 'Gastric adenocarcinoma is the 4th most frequent cancer and the 2nd leading cause of cancer mortality. Most of the patients have metastatic, locally advanced or recurrent unresectable disease. So, systemic treatment remains an important issue especially since chemotherapy improves survival and quality of life (compared to best supportive care alone).\n\nSecond-line chemotherapy-based treatment improves overall survival (OS) as compared to best supportive care alone in patients with an acceptable general condition (performance status 0-2). Indeed, with docetaxel monotherapy there was a significant difference in overall survival for the chemotherapy arm with a median of 5.2 versus 3.6 months in best supportive care alone arm (HR=0.67, p=0.01). Irinotecan monotherapy also significantly improves overall survival compared to supportive care alone in a phase III study (4.0 versus 2.4 months; HR=0.48, 95%CI 0.25-0.92; p=0.012).\n\nBased on a phase III trial FOLFIRI (5-FU plus irinotecan) is one most used regimen in second-line in European countries, especially in France. FFCD 0307 trial, a phase III comparing FOLFIRI-ECX (epirubicin-cisplatin-capecitabine) to the reverse sequence (ECX-FOLFIRI), showed that both sequences are possible.\n\nPreliminary results in metastatic gastric cancer with anti-PD1 mAbs are highly promising. In a trial with pembrolizumab, only PD-L1 positive tumors were eligible to the treatment with a cut off at 1%. Thirty-nine patients were enrolled and 67% had received at least two prior chemotherapy regimens. The overall response rate was 22%. The median PFS and OS were 1.9 months and 11.4 months, respectively. KEYNOTE-059 Phase 2 multicohort study with pembrolizumab monotherapy in advanced gastric cancer treatment has been presented at ASCO 2017 meeting. Among 259 patients included in the trial response rate was 11.6%. OS was 5.6 months. Response rates were 15.5% in PDL1+ tumors versus 6.4% in PDL1- tumors and 57.1% in MSI tumors versus 9% in MSS tumors. Up until now, overlap between microsatellite instability and PD-L1 expression is unknown in gastric cancer. An anti-PD-L1 mAb (avelumab) was evaluated in a phase Ib expansion study (n=20, Japanese patients), with 15% of objective response rate and 11.9 weeks for progression-free survival. A second cohort with avelumab included 55 patients for maintenance therapy after first-line chemotherapy, with 7.3% of objective response rate and 14 weeks of PFS. Phase I/II CheckMate-032 evaluated nivolumab (anti-PD-1) ± ipilimumab (anti-CTLA4) at different doses in advanced gastric cancer (17). The overall response rate was between 8% to 24% and the median OS between 4.8 to 6.9 months according to treatment arm.\n\nOthers anti-PD1/anti-PD-L1/anti-CTLA4 mAbs are also currently under investigation in gastric cancer alone or in combination with chemotherapy. Nevertheless, up until now there is no published data concerning ICI plus chemotherapy in gastric cancer. The present randomized multicentric non-comparative phase II study aimed to assess the rate of patients alive and without progression at 4 months with advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, pre-treated with fluoropyrimidine + platinum +/- taxane, with two arms Folfiri plus durvalumab versus Folfiri plus durvalumab plus tremelimumab. Indeed, most patients in the French multicentric first-line GASTFOX trial (506 patients planned between 2017 and 2020) can be included in the second-line setting in the DURIGAST trial. Due to the lack of data concerning Folfiri plus durvalumab plus tremelimumab combination, a safety run-in phase will be performed at the beginning of the DURIGAST trial.', 'Condition': 'Gastric Adenocarcinoma\nGastric Cancer', 'Detailed Description': 'Gastric adenocarcinoma is the fourth most frequent cancer and the second leading cause of cancer mortality. Advanced gastric adenocarcinoma has a poor prognosis with short overall survival (ranging from 10% to 15% at 5-years) even after surgical complete resection and despite the progress in therapeutic approaches. Most of the patients have metastatic, locally advanced or recurrent unresectable disease. So, systemic treatment remains an important issue especially since chemotherapy improves survival and quality of life (compared to best supportive care alone). First-line chemotherapy depends on HER2 status, which also influenced overall survival (14 months for HER2 positive versus 10 months for HER2 negative tumors). In HER2 negative tumors standard first-line regimen is a doublet of fluoropyrimidine (5-fluorouracil or capecitabine) plus a platinum salt (cisplatin or oxaliplatin). 5-fluorouracil (5-FU) and capecitabine as also cisplatin and oxaliplatin have similar efficacy but different toxicities.\n\nIn patients whose tumor overexpresses the HER2 receptor adding trastuzumab to fluoropyrimidine/cisplatin regimen increased overall survival compared to chemotherapy alone. In HER2 negative tumors the addition of docetaxel to cisplatin/fluoropyrimidine regimen increased overall survival but its use remains limited in clinical practice because of its high toxicity. Preliminary results demonstrated a high efficacy with less toxicities of docetaxel-oxaliplatin-fluoropyrimidine combination, also called TFOX/FLOT regimen. Indeed, in France a large phase III trial comparing TFOX versus FOLFOX in first-line treatment of patients with advanced gastric or gastro-oesophageal junction adenocarcinoma is ongoing (GASTFOX, trial NCT03006432). Primary endpoint is progression-free survival (PFS) and 506 patients are planned between 2017 and 2020 (actually at the date of January 30, 2018, 65 patients are included).\n\nSecond-line chemotherapy improves overall survival (OS) as compared to best supportive care alone in patients with an acceptable general condition (performance status 0-2). Indeed, with docetaxel monotherapy there was a significant difference in overall survival for the chemotherapy arm with a median of 5.2 versus 3.6 months in best supportive care alone arm (HR=0.67, p=0.01). Weekly paclitaxel monotherapy is also used because of its good efficacy-toxicity ratio. Irinotecan monotherapy also significantly improves overall survival compared to supportive care alone in a phase III study (4.0 versus 2.4 months; HR=0.48, 95%CI 0.25-0.92; p=0.012). Recently ramucirumab monotherapy demonstrated its efficacy on overall survival in a randomized, placebo-controlled second-line metastatic study. In a randomized phase 3 trial ramucirumab also showed its efficacy in combination with paclitaxel versus paclitaxel monotherapy with a median overall survival of 9.6 versus 7.4 months, respectively (p=0.017; HR=0.81). However, the "amelioration du service medical rendu" (ASMR) assessed by the French "Haute Autorité de Santé" (HAS) consider an insufficient benefit to a reimbursement of ramucirumab in France. The HAS gave a moderate ASMR opinion (ASMR IV).\n\nDocetaxel is more and more frequently used in first-line chemotherapy then in this setting taxane (alone or combined with others drugs) cannot be used as second-line regimen. Indeed, based on a phase III trial FOLFIRI (5-FU plus irinotecan) is one most used regimen in second-line in European countries, especially in France. FFCD 0307 trial, a phase III comparing FOLFIRI-ECX (epirubicin-cisplatin-capecitabine) to the reverse sequence (ECX-FOLFIRI), showed that both sequences are possible.\n\nHuman tumors tend to activate the immune system regulatory checkpoints as a means of escaping immunosurveillance. For instance, interaction between PD1 (Program Death 1) and PD-L1 (Program Death 1 ligand) will lead the activated T cell to a state of anergy. PD-L1 is up regulated on a wide range of cancers. Anti-PD1 and anti-PD-L1 monoclonal antibodies (mAbs), called immune checkpoint inhibitors (ICIs), have consequently been designed to restore T cell activity. Others ICIs are investigated, notably cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors. CTLA-4 transmits an inhibitory signal to T cells to prevent early excessive T cell activation. CTLA4 blockade may stimulate a more robust antitumor response by sustaining activation and proliferation of T lymphocytes and may overcome immune suppression mediated by regulatory T cells. ICIs have been recently tested in many cancers with promising results, especially in tumors with microsatellite instability (MSI) and/or PD-L1 overexpression.\n\nPreliminary results in metastatic gastric cancer with anti-PD1 mAbs are highly promising. In a trial with pembrolizumab, only PD-L1 positive tumors were eligible to the treatment with a cut off at 1%. Thirty-nine patients were enrolled and 67% had received at least two prior chemotherapy regimens. The overall response rate was 22%. The median PFS and OS were 1.9 months and 11.4 months, respectively. KEYNOTE-059 Phase 2 multicohort study with pembrolizumab monotherapy in advanced gastric cancer treatment has been presented at ASCO 2017 meeting. Among 259 patients included in the trial response rate was 11.6%. OS was 5.6 months. Response rates were 15.5% in PDL1+ tumors versus 6.4% in PDL1- tumors and 57.1% in MSI tumors versus 9% in MSS tumors. Up until now, overlap between microsatellite instability and PD-L1 expression is unknown in gastric cancer. An anti-PD-L1 mAb (avelumab) was evaluated in a phase Ib expansion study (n=20, Japanese patients), with 15% of objective response rate and 11.9 weeks for progression-free survival. A second cohort with avelumab included 55 patients for maintenance therapy after first-line chemotherapy, with 7.3% of objective response rate and 14 weeks of PFS. Phase I/II CheckMate-032 evaluated nivolumab (anti-PD-1) ± ipilimumab (anti-CTLA4) at different doses in advanced gastric cancer (17). The overall response rate was between 8% to 24% and the median OS between 4.8 to 6.9 months according to treatment arm.\n\nOthers anti-PD1/anti-PD-L1/anti-CTLA4 mAbs are also currently under investigation in gastric cancer alone or in combination with chemotherapy. Nevertheless, up until now there is no published data concerning ICI plus chemotherapy in gastric cancer. Finally, immunogenic cell death induced by chemotherapy may enhance efficacy of ICIs. Durvalumab (MEDI4736) is a human monoclonal antibody directed against PD-L1 in development for the treatment of many cancers. A phase I study included 16 patients with advanced gastric cancer and the objective response rate was 25%. Tremelimumab is a fully human monoclonal antibody against CTLA-4. Durvalumab plus tremelimumab combination showed a manageable tolerability profile, with antitumour activity irrespective of PD-L1 status in non-small cell lung cancer (NSCLC). Durvalumab alone or combined with tremelimumab is evaluated in phase III studies in NSCLC (e.g NEPTUNE and MYSTIC), small cell lung cancer (CASPIAN), hepatocellular carcinoma (HIMALAYA), bladder cancer (DANUBE) and head and neck cancer (EAGLE and KESTREL).\n\nConcerning safety of anti-PD1 plus anti-CTLA4 combination, in the randomized phase I/II CheckMate-032 study, that included 160 patients, there was no unexpected toxicity signal. Grade 3 and 4 treatment-related adverse events were 17%, 47%, and 27%, respectively. These rates of grade 3 and 4 treatment-related adverse events are those usually found with the anti-PD1 plus anti-CTLA4 combination in other tumors, observed approximately in 40% of patients. Up until now, there is no published data concerning combination of ICIs plus irinotecan. Nevertheless, in all trial combining chemotherapy plus anti-PD1 and/or anti-CTLA4 chemotherapy drugs were used at full-dose (5FU, oxaliplatin, cisplatin…). An Italian trial just started and combined full-dose FOLFOXIRI (5-FU 3200 mg/m2 plus irinotecan 165 mg/m2 and oxaliplatin 85 mg/m2) with bevacizumab (5 mg/kg) and atezolizumab (anti-PD-L1, 840 mg) in metastatic colorectal cancers as first-line treatment. FOLFOXIRI is a triplet chemotherapy more "toxic" than FOLFIRI doublet chemotherapy and this trial is a randomized phase II (FOLFOXIRI plus bevacizumab and atezolizumab versus FOLFOXIRI plus bevacizumab). There is, however, a preliminary safety phase in 6 patients, once they have all received at least 2 cycles of treatment, the latter being administered at full dose (AtezoTRIBE trial, NCT03721653).\n\nThe present randomized multicentric non-comparative phase II study aimed to assess the rate of patients alive and without progression at 4 months with advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, pre-treated with fluoropyrimidine + platinum +/- taxane, with two arms Folfiri plus durvalumab versus Folfiri plus durvalumab plus tremelimumab. Indeed, most patients in the French multicentric first-line GASTFOX trial (506 patients planned between 2017 and 2020) can be included in the second-line setting in the DURIGAST trial. Due to the lack of data concerning Folfiri plus durvalumab plus tremelimumab combination, a safety run-in phase will be performed at the beginning of the DURIGAST trial.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥ 18 years.\nBody weight > 30kg.\nHistologically proven advanced-stage unresectable adenocarcinoma of the stomach or the GEJ (Siewert II or III).\nKnown MSS/MSI status or tumor tissue available (frozen or paraffin-embedded, primary tumors or metastases) in order to allow determination of MSS/MSI status. The investigator needs to ensure that tumor tissues will be sent after patient randomization.\nFailure to platinium-based 1st line therapy with or without trastuzumab, or early recurrent disease after surgery with neo-adjuvant and/or adjuvant platinium-based chemotherapy (within 6 months of the end of chemotherapy) or progression during neo-adjuvant and/or adjuvant platinium-based chemotherapy.\nEligible for a second-line treatment with irinotecan and 5-FU.\nMeasurable or non-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\nEastern Cooperative Oncology Group (ECOG) performance status 0-1.\nAdequate organ function: ANC ≥ 1.5 x 109/L, haemoglobin ≥ 9 g/dL, platelets ≥ 100 x 109/L, AST/ALT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastase(s)), GGT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastase(s)), bilirubin ≤ 1.5 x ULN, creatinin clearance > 40 mL/min (MDRD).\nEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.\nMan and woman who childbearing potential agrees to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 6 months after the last treatment intake.\nPatient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures performed.'}
|
{'Arm - Disease - Stage of Cancer': 'Advanced'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03863483
|
{'Official Title': 'A Phase II, Prospective, Single-center, Randomized, Controlled Study to Investigate the Efficacy and Safety of Sintilimab or Placebo in Combination With Chemotherapy as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy', 'Brief Summary': 'This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab or placebo in combination with chemotherapy as second-line treatment for patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.', 'Condition': 'Nonsquamous Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nVolunteer to participate in clinical research; fully understand and know the research and sign informed consent;\r\nAge ≥ 18 years old and ≤ 75 years old, either sex;\r\nEastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;\r\nHas a histologically or cytologically confirmed diagnosis of stage IV (according to the 8th edition of the International Association for the Study of Lung Cancer) nonsquamous NSCLC;\r\nHave at least one measurable lesion as defined by RECIST 1.1;\r\nHas progression of disease after treatment with at least two cycles of a platinum-containing doublet chemotherapy according to RECIST V.1.1;\r\nPatients without activating EGFR mutation;\r\nNormal hepatic function: total bilirubin≤1.5×normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ≤2.5×ULN or ≤5×ULN if liver metastasis is present;\r\nNormal renal function: Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate );\r\nNormal hematological function: absolute neutrophil count ≥1.5×109/L, platelet count ≥70×109/L, hemoglobin≥80g/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency];\r\nHas a life expectancy of at ≥3 months.'}
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{'Arm - Disease - Stage of Cancer': 'Stage IV '}
| 0
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT03863483
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{'Official Title': 'A Phase II, Prospective, Single-center, Randomized, Controlled Study to Investigate the Efficacy and Safety of Sintilimab or Placebo in Combination With Chemotherapy as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy', 'Brief Summary': 'This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab or placebo in combination with chemotherapy as second-line treatment for patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.', 'Condition': 'Nonsquamous Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nVolunteer to participate in clinical research; fully understand and know the research and sign informed consent;\r\nAge ≥ 18 years old and ≤ 75 years old, either sex;\r\nEastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;\r\nHas a histologically or cytologically confirmed diagnosis of stage IV (according to the 8th edition of the International Association for the Study of Lung Cancer) nonsquamous NSCLC;\r\nHave at least one measurable lesion as defined by RECIST 1.1;\r\nHas progression of disease after treatment with at least two cycles of a platinum-containing doublet chemotherapy according to RECIST V.1.1;\r\nPatients without activating EGFR mutation;\r\nNormal hepatic function: total bilirubin≤1.5×normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ≤2.5×ULN or ≤5×ULN if liver metastasis is present;\r\nNormal renal function: Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate );\r\nNormal hematological function: absolute neutrophil count ≥1.5×109/L, platelet count ≥70×109/L, hemoglobin≥80g/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency];\r\nHas a life expectancy of at ≥3 months.'}
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{'Arm - Disease - Stage of Cancer': 'Stage IV '}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05179239
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{'Official Title': 'A Randomized，Double-blind，Controlled，Multi-center Phase III Clinical Study Evaluating SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer.', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAged 18-70 years, female.\nWith Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.\nWith a life expectancy of ≥ 12 weeks.\nAcute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).\nWith at least one measurable lesion as per RECIST v1.1.\nWith histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.\nPersistent, recurrent, or metastatic cervical cancer.\nPatients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).\nWomen of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.\nPatients must agree and have signed the informed consent form.'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05179239
|
{'Official Title': 'A Randomized，Double-blind，Controlled，Multi-center Phase III Clinical Study Evaluating SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer.', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAged 18-70 years, female.\nWith Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.\nWith a life expectancy of ≥ 12 weeks.\nAcute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).\nWith at least one measurable lesion as per RECIST v1.1.\nWith histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.\nPersistent, recurrent, or metastatic cervical cancer.\nPatients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).\nWomen of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.\nPatients must agree and have signed the informed consent form.'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05179239
|
{'Official Title': 'A Randomized，Double-blind，Controlled，Multi-center Phase III Clinical Study Evaluating SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer.', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAged 18-70 years, female.\nWith Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.\nWith a life expectancy of ≥ 12 weeks.\nAcute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).\nWith at least one measurable lesion as per RECIST v1.1.\nWith histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.\nPersistent, recurrent, or metastatic cervical cancer.\nPatients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).\nWomen of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.\nPatients must agree and have signed the informed consent form.'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT04732494
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{'Official Title': 'A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 Tumor Area Positivity (TAP) ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma', 'Brief Summary': 'A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.', 'Condition': 'Esophageal Squamous Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically confirmed diagnosis of (esophageal squamous cell carcinoma) ESCC.\nHave PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.\nHave measurable disease as assessed by RECIST v1.1.\nHave confirmed PD-L1 TAP ≥ 10% in tumor tissues tested by the central lab.\nEastern Cooperative Oncology Group Performance Status score of 0 or 1.'}
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{'Arm - Disease - Stage of Cancer': 'Locally Advanced, Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT04732494
|
{'Official Title': 'A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 Tumor Area Positivity (TAP) ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma', 'Brief Summary': 'A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.', 'Condition': 'Esophageal Squamous Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically confirmed diagnosis of (esophageal squamous cell carcinoma) ESCC.\nHave PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.\nHave measurable disease as assessed by RECIST v1.1.\nHave confirmed PD-L1 TAP ≥ 10% in tumor tissues tested by the central lab.\nEastern Cooperative Oncology Group Performance Status score of 0 or 1.'}
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{'Arm - Disease - Stage of Cancer': 'Locally Advanced, Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT04269200
|
{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)\n', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n', 'Condition': 'Endometrial Neoplasms\n', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer\n\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥18 years at the time of screening and female.\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\nPatient must have endometrial cancer in one of the following categories:\n\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\nFPPE tumor sample must be available for MMR evaluation.\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}
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{'Arm - Disease - Stage of Cancer': 'Advanced'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT04269200
|
{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)\n', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n', 'Condition': 'Endometrial Neoplasms\n', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer\n\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥18 years at the time of screening and female.\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\nPatient must have endometrial cancer in one of the following categories:\n\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\nFPPE tumor sample must be available for MMR evaluation.\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}
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{'Arm - Disease - Stage of Cancer': 'Advanced'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT04269200
|
{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)\n', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n', 'Condition': 'Endometrial Neoplasms\n', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer\n\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥18 years at the time of screening and female.\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\nPatient must have endometrial cancer in one of the following categories:\n\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\nFPPE tumor sample must be available for MMR evaluation.\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}
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{'Arm - Disease - Stage of Cancer': 'Advanced'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT04916613
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{'Official Title': 'A Double-blind Randomised Phase III Trial Evaluating the Efficacy of ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability and Not Elected for Docetaxel or Androgen Receptor Targeted Agents', 'Brief Summary': 'This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors.', 'Condition': 'Prostate Cancer Metastatic', 'Detailed Description': 'This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 patients who will be randomized (1:1) to receive either: (i) Experimental arm: ADT + darolutamide 600 mg po bid, or (ii) Control arm: ADT + placebo po bid. Response to treatment will be assessed according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria (Scher, 2016). Treatment will be continued until radiographic disease progression. Treatment may also be terminated at the initiative of either the patient or the investigator for any reason that would be beneficial to the patient, including: unacceptable toxicity, intercurrent conditions that preclude continuation of treatment, or patient request. Following treatment discontinuation patients will enter the follow-up period and will be monitored for up to 10 years with regards to survival status, subsequent antineoplastic treatments and the status of ongoing adverse events (AEs) and/or new investigational product related AEs.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nSigned a written informed consent form prior to any trial specific procedures.\r\nMen with histologically or cytologically confirmed adenocarcinoma of the prostate.\r\nAged ≥18 years old at the time of signing informed consent.\r\nDe novo metastatic disease defined by clinical or radiological evidence of metastases.\r\n\r\nNote: For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\r\n\r\nAt least one extra-pelvic lymph node ≥2 cm\r\nAt least one extra-pelvic lymph node ≥1 cm if the patients also have at least one pelvic lymph node ≥2 cm\r\nMeasurable disease or bone lesions that are evaluable according to PCWG3 criteria.\r\nIneligible for treatment with all of the following drugs: docetaxel, abiraterone, enzalutamide, apalutamide; AND meets at least one of the following frailty criteria:\r\n\r\nActivities of daily living (ADL) assessment (excluding urinary incontinence question) score 3 or 4/5;\r\n4-Instrumental activities of daily living (4-IADL) assessment score 2 or 3/4;\r\nA Grade 3 event on the Cumulative Illness Score Rating-Geriatrics (CISR-G) questionnaire;\r\nBody mass index (BMI) ≤21 kg/m² and/or >10% weight loss in the last 6 months;\r\nTimed up and go test (TUG) >14 sec.\r\nAdequate bone marrow function: haemoglobin ≥80 g/L, white blood cells ≥3.0 x10⁹/L and platelets ≥80 x10⁹/L.\r\nAdequate liver function: alanine aminotransferase (ALT) <2 x upper limit of normal (ULN) and bilirubin <1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must have a normal conjugated bilirubin). For patients with documented liver metastasis, ALT <5 x ULN is acceptable.\r\nAdequate renal function: calculated creatinine clearance >30 ml/min (using the Modification of Diet in Renal Disease [MDRD] or Chronic Kidney Disease Epidemiology Collaboration [CKD EPI) method).\r\nFor sexually active men, agreement to use adequate contraception for the duration of trial participation and up to 2 weeks after completing study treatment.\r\nAffiliated to the social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials).\r\nWilling and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic '}
| 0
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT04916613
|
{'Official Title': 'A Double-blind Randomised Phase III Trial Evaluating the Efficacy of ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability and Not Elected for Docetaxel or Androgen Receptor Targeted Agents', 'Brief Summary': 'This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors.', 'Condition': 'Prostate Cancer Metastatic', 'Detailed Description': 'This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 patients who will be randomized (1:1) to receive either: (i) Experimental arm: ADT + darolutamide 600 mg po bid, or (ii) Control arm: ADT + placebo po bid. Response to treatment will be assessed according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria (Scher, 2016). Treatment will be continued until radiographic disease progression. Treatment may also be terminated at the initiative of either the patient or the investigator for any reason that would be beneficial to the patient, including: unacceptable toxicity, intercurrent conditions that preclude continuation of treatment, or patient request. Following treatment discontinuation patients will enter the follow-up period and will be monitored for up to 10 years with regards to survival status, subsequent antineoplastic treatments and the status of ongoing adverse events (AEs) and/or new investigational product related AEs.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nSigned a written informed consent form prior to any trial specific procedures.\r\nMen with histologically or cytologically confirmed adenocarcinoma of the prostate.\r\nAged ≥18 years old at the time of signing informed consent.\r\nDe novo metastatic disease defined by clinical or radiological evidence of metastases.\r\n\r\nNote: For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\r\n\r\nAt least one extra-pelvic lymph node ≥2 cm\r\nAt least one extra-pelvic lymph node ≥1 cm if the patients also have at least one pelvic lymph node ≥2 cm\r\nMeasurable disease or bone lesions that are evaluable according to PCWG3 criteria.\r\nIneligible for treatment with all of the following drugs: docetaxel, abiraterone, enzalutamide, apalutamide; AND meets at least one of the following frailty criteria:\r\n\r\nActivities of daily living (ADL) assessment (excluding urinary incontinence question) score 3 or 4/5;\r\n4-Instrumental activities of daily living (4-IADL) assessment score 2 or 3/4;\r\nA Grade 3 event on the Cumulative Illness Score Rating-Geriatrics (CISR-G) questionnaire;\r\nBody mass index (BMI) ≤21 kg/m² and/or >10% weight loss in the last 6 months;\r\nTimed up and go test (TUG) >14 sec.\r\nAdequate bone marrow function: haemoglobin ≥80 g/L, white blood cells ≥3.0 x10⁹/L and platelets ≥80 x10⁹/L.\r\nAdequate liver function: alanine aminotransferase (ALT) <2 x upper limit of normal (ULN) and bilirubin <1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must have a normal conjugated bilirubin). For patients with documented liver metastasis, ALT <5 x ULN is acceptable.\r\nAdequate renal function: calculated creatinine clearance >30 ml/min (using the Modification of Diet in Renal Disease [MDRD] or Chronic Kidney Disease Epidemiology Collaboration [CKD EPI) method).\r\nFor sexually active men, agreement to use adequate contraception for the duration of trial participation and up to 2 weeks after completing study treatment.\r\nAffiliated to the social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials).\r\nWilling and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic '}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT03740165
|
{'Official Title': 'A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.\n\nThe primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.', 'Condition': 'Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms', 'Detailed Description': "Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel*, participants will be randomly assigned in to one of three treatment arms:\n\nPembrolizumab + Olaparib,\nPembrolizumab + Placebo for Olaparib\nPlacebo for Pembrolizumab + Placebo for Olaparib\n\nAt Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected:\n\nup to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle\nup to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle; or\nup to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle.\nDocetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg/m^2 Q3W plus carboplatin AUC 5 Q3W.", 'Inclusion Criteria': 'Inclusion Criteria:\n\nHas histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer\nHas just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery\nIs a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting\nCandidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25\nIs able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1\nFemale participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\nHas adequate organ function'}
|
{'Arm - Disease - Stage of Cancer': 'Advanced Stage III or Stage IV EOC'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03740165
|
{'Official Title': 'A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.\n\nThe primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.', 'Condition': 'Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms', 'Detailed Description': "Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel*, participants will be randomly assigned in to one of three treatment arms:\n\nPembrolizumab + Olaparib,\nPembrolizumab + Placebo for Olaparib\nPlacebo for Pembrolizumab + Placebo for Olaparib\n\nAt Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected:\n\nup to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle\nup to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle; or\nup to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle.\nDocetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg/m^2 Q3W plus carboplatin AUC 5 Q3W.", 'Inclusion Criteria': 'Inclusion Criteria:\n\nHas histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer\nHas just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery\nIs a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting\nCandidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25\nIs able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1\nFemale participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\nHas adequate organ function'}
|
{'Arm - Disease - Stage of Cancer': 'Advanced Stage III or Stage IV EOC'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT03740165
|
{'Official Title': 'A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.\n\nThe primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.', 'Condition': 'Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms', 'Detailed Description': "Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel*, participants will be randomly assigned in to one of three treatment arms:\n\nPembrolizumab + Olaparib,\nPembrolizumab + Placebo for Olaparib\nPlacebo for Pembrolizumab + Placebo for Olaparib\n\nAt Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected:\n\nup to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle\nup to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle; or\nup to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle.\nDocetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg/m^2 Q3W plus carboplatin AUC 5 Q3W.", 'Inclusion Criteria': 'Inclusion Criteria:\n\nHas histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer\nHas just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery\nIs a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting\nCandidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25\nIs able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1\nFemale participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\nHas adequate organ function'}
|
{'Arm - Disease - Stage of Cancer': 'Advanced Stage III or Stage IV EOC'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05580562
|
{'Official Title': 'ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.', 'Condition': 'Glioma', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nAble to understand the study procedures and agree to participate in the study by providing written informed consent (by participant or legally authorized representative), and assent when applicable.\r\nBody weight ≥ 10 kg at time of randomization.\r\nHistologically diagnosed H3 K27M-mutant diffuse glioma (new diagnosis). Detection of a missense K27M mutation in any histone H3-encoding gene detected by testing of tumor tissue (immunohistochemistry [IHC] or next-generation sequencing [NGS] in a Clinical Laboratory Improvement Amendments [CLIA]-certified or equivalent laboratory). [Site to provide (as available): ≥ 10 unstained formalin-fixed paraffin-embedded (FFPE) slides from tumor tissue.]\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained prior to starting radiotherapy for submission to sponsor's imaging vendor for central read. For participants who had a surgical resection, this scan must be post-resection; for participants who did not have a resection, this scan may be pre- or post-biopsy.\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained 2 to 6 weeks after completion of frontline radiotherapy. [Site to also provide all available MRIs completed prior to initiating treatment with study intervention.]\r\nCompleted standard frontline radiotherapy within 2 to 6 weeks prior to randomization. Standard frontline radiotherapy is defined as a dose of 54 to 60 Gy at 1.8 to 2.2 Gy/fraction. Radiotherapy must be initiated within 12 weeks from initial diagnosis of H3 K27M-mutant diffuse glioma and within 8 weeks of most recent surgical resection/biopsy.\r\nKarnofsky Performance Status or Lansky Performance Status ≥ 70 at time of randomization.\r\nStable or decreasing dose of corticosteroids and anti-seizure medications for 7 days prior to randomization, if applicable. Stable steroid dose is defined as ≤ 2 mg/day increase (based on dexamethasone dose or equivalent dose of an alternative steroid)."}
|
{'Arm - Disease - Stage of Cancer': 'Newly diagnosed'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05580562
|
{'Official Title': 'ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.', 'Condition': 'Glioma', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nAble to understand the study procedures and agree to participate in the study by providing written informed consent (by participant or legally authorized representative), and assent when applicable.\r\nBody weight ≥ 10 kg at time of randomization.\r\nHistologically diagnosed H3 K27M-mutant diffuse glioma (new diagnosis). Detection of a missense K27M mutation in any histone H3-encoding gene detected by testing of tumor tissue (immunohistochemistry [IHC] or next-generation sequencing [NGS] in a Clinical Laboratory Improvement Amendments [CLIA]-certified or equivalent laboratory). [Site to provide (as available): ≥ 10 unstained formalin-fixed paraffin-embedded (FFPE) slides from tumor tissue.]\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained prior to starting radiotherapy for submission to sponsor's imaging vendor for central read. For participants who had a surgical resection, this scan must be post-resection; for participants who did not have a resection, this scan may be pre- or post-biopsy.\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained 2 to 6 weeks after completion of frontline radiotherapy. [Site to also provide all available MRIs completed prior to initiating treatment with study intervention.]\r\nCompleted standard frontline radiotherapy within 2 to 6 weeks prior to randomization. Standard frontline radiotherapy is defined as a dose of 54 to 60 Gy at 1.8 to 2.2 Gy/fraction. Radiotherapy must be initiated within 12 weeks from initial diagnosis of H3 K27M-mutant diffuse glioma and within 8 weeks of most recent surgical resection/biopsy.\r\nKarnofsky Performance Status or Lansky Performance Status ≥ 70 at time of randomization.\r\nStable or decreasing dose of corticosteroids and anti-seizure medications for 7 days prior to randomization, if applicable. Stable steroid dose is defined as ≤ 2 mg/day increase (based on dexamethasone dose or equivalent dose of an alternative steroid)."}
|
{'Arm - Disease - Stage of Cancer': 'Newly diagnosed'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05580562
|
{'Official Title': 'ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.', 'Condition': 'Glioma', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nAble to understand the study procedures and agree to participate in the study by providing written informed consent (by participant or legally authorized representative), and assent when applicable.\r\nBody weight ≥ 10 kg at time of randomization.\r\nHistologically diagnosed H3 K27M-mutant diffuse glioma (new diagnosis). Detection of a missense K27M mutation in any histone H3-encoding gene detected by testing of tumor tissue (immunohistochemistry [IHC] or next-generation sequencing [NGS] in a Clinical Laboratory Improvement Amendments [CLIA]-certified or equivalent laboratory). [Site to provide (as available): ≥ 10 unstained formalin-fixed paraffin-embedded (FFPE) slides from tumor tissue.]\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained prior to starting radiotherapy for submission to sponsor's imaging vendor for central read. For participants who had a surgical resection, this scan must be post-resection; for participants who did not have a resection, this scan may be pre- or post-biopsy.\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained 2 to 6 weeks after completion of frontline radiotherapy. [Site to also provide all available MRIs completed prior to initiating treatment with study intervention.]\r\nCompleted standard frontline radiotherapy within 2 to 6 weeks prior to randomization. Standard frontline radiotherapy is defined as a dose of 54 to 60 Gy at 1.8 to 2.2 Gy/fraction. Radiotherapy must be initiated within 12 weeks from initial diagnosis of H3 K27M-mutant diffuse glioma and within 8 weeks of most recent surgical resection/biopsy.\r\nKarnofsky Performance Status or Lansky Performance Status ≥ 70 at time of randomization.\r\nStable or decreasing dose of corticosteroids and anti-seizure medications for 7 days prior to randomization, if applicable. Stable steroid dose is defined as ≤ 2 mg/day increase (based on dexamethasone dose or equivalent dose of an alternative steroid)."}
|
{'Arm - Disease - Stage of Cancer': 'Newly diagnosed'}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT04853043
|
{'Official Title': 'APK Mutant: A Single Arm Phase II Study of Cetuximab in Third Line for Mutant APC, TP53 and RAS Patients With Refractory Metastatic Colorectal Cancer', 'Brief Summary': 'A prospective, multi-center, phase II study of 21 patients to evaluate the efficacy of the EGFR inhibitor, Cetuximab in patients with mCRC harboring APC, TP53 and RAS mutations.', 'Condition': 'Colorectal Cancer', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\n\nMale or female subject aged ≥ 18 years.\nHistologically confirmed metastatic colorectal adenocarcinoma with mutant APC, TP53 and KRAS genes as determined by the local CLIA-certified laboratory are eligible. All RAS mutations are allowed (KRAS, NRAS, HRAS). Patients with wild type KRAS, APC or TP53 are ineligible..\nProgression or unwanted toxicities on atleast 2 prior lines of treatment including 5-Flourouracil, oxaliplatin and irinotecan based regimen\nStudy participants must have measurable disease by RECIST 1.1 criteria by CT or MRI.\nECOG Performance Status ≤ 2.\nStudy participants with treated and/or stable brain metastases are allowed\nStudy participants must have anticipated life expectancy > 3 months\nAdequate organ function as defined as:\n\nHematologic:\n\nAbsolute neutrophil count (ANC) ≥ ≥1000/µL\nPlatelet count ≥ 100,000/mm3\nHemoglobin ≥ 9 g/dL\nHepatic:\n\nSerum Bilirubin ≤ 2 x ULN or ≤ 3 x ULN for subjects with Gilbert's syndrome\nAspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases)\nRenal:\n\nSerum creatinine ≤1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed)\nFor female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\nWomen < 50 years of age:\n\nAmenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\nLuteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\nUnderwent surgical sterilization (bilateral oophorectomy or hysterectomy).\nWomen ≥ 50 years of age:\n\nAmenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\nHad radiation-induced menopause with last menses >1 year ago; or\nHad chemotherapy-induced menopause with last menses >1 year ago; or\nUnderwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\nFemale subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception throughout the study and for atleast 12 months after last study treatment administration.\nMale subjects must agree to use a condom during intercourse for the duration of study therapy and for atleast 12 months after last study treatment administration.\nRecovery to baseline or ≤ Grade 1 CTCAE v5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator.\nAble to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines."}
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{'Arm - Disease - Stage of Cancer': 'Metastatic '}
| 0
|
Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05987358
|
{'Official Title': 'A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of TQB3454 Tablets in the Treatment of Advanced Biliary Tract Cancer With Isocitrate Dehydrogenase 1 (IDH1) Mutation.\n', 'Brief Summary': 'This study used a randomized, controlled, double-blind, multicenter Phase III clinical design with overall survival (OS) as the primary endpoint. About 165 patients with advanced biliary carcinoma were enrolled and randomly assigned to the experimental group and the control group in a 2:1 ratio to receive TQB3454 tablets or the placebo, respectively, to evaluate the efficacy and safety of TQB3454 tablets in the treatment of advanced biliary carcinoma.\n', 'Condition': 'Biliary Carcinoma\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nage ≥18 years old, ≤75 years old (calculated on the date of signing the informed consent); Eastern Cooperative oncology Group (ECOG) score 0 ~ 2.\nTumor tissue samples must be provided for genetic testing (10 puncture paraffin sections or 5 surgical paraffin sections).\nPatients with viral hepatitis: Patients should be treated symptomatically until the virus is stable before enrollment, and treatment should be maintained during the experimental period.\nThe main organs have good functions.\nMeet the criteria for advanced biliary carcinoma:\n\ncholangiocarcinoma histologically or cytologically confirmed\nLocally advanced, relapsing, and/or metastatic disease that is not operable and has at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors V1.1 (RECIST 1.1) criteria.\nPrevious gemcitabine and fluorouracil (and/or platinum-based) drug therapy failed.\nWomen of reproductive age should agree that they must use effective contraception during the study period and for 6 months after the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for six months after the end of the study period.\nThe subjects voluntarily joined the study, signed the informed consent, and the compliance was good.'}
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{'Arm - Disease - Stage of Cancer': 'Locally Advanced, Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05987358
|
{'Official Title': 'A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of TQB3454 Tablets in the Treatment of Advanced Biliary Tract Cancer With Isocitrate Dehydrogenase 1 (IDH1) Mutation.\n', 'Brief Summary': 'This study used a randomized, controlled, double-blind, multicenter Phase III clinical design with overall survival (OS) as the primary endpoint. About 165 patients with advanced biliary carcinoma were enrolled and randomly assigned to the experimental group and the control group in a 2:1 ratio to receive TQB3454 tablets or the placebo, respectively, to evaluate the efficacy and safety of TQB3454 tablets in the treatment of advanced biliary carcinoma.\n', 'Condition': 'Biliary Carcinoma\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nage ≥18 years old, ≤75 years old (calculated on the date of signing the informed consent); Eastern Cooperative oncology Group (ECOG) score 0 ~ 2.\nTumor tissue samples must be provided for genetic testing (10 puncture paraffin sections or 5 surgical paraffin sections).\nPatients with viral hepatitis: Patients should be treated symptomatically until the virus is stable before enrollment, and treatment should be maintained during the experimental period.\nThe main organs have good functions.\nMeet the criteria for advanced biliary carcinoma:\n\ncholangiocarcinoma histologically or cytologically confirmed\nLocally advanced, relapsing, and/or metastatic disease that is not operable and has at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors V1.1 (RECIST 1.1) criteria.\nPrevious gemcitabine and fluorouracil (and/or platinum-based) drug therapy failed.\nWomen of reproductive age should agree that they must use effective contraception during the study period and for 6 months after the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for six months after the end of the study period.\nThe subjects voluntarily joined the study, signed the informed consent, and the compliance was good.'}
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{'Arm - Disease - Stage of Cancer': 'Locally Advanced, Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT02773524
|
{'Official Title': 'A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)\n', 'Brief Summary': 'A randomised phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo)\n', 'Condition': 'Gastro-Oesophageal Cancer\n', 'Detailed Description': 'Purpose:\n\nThe purpose of this Phase III study is to determine if regorafenib improves overall survival in patients with Advanced Gastro-Oesophageal Carcinoma.\n\nWho is it for:\n\nYou may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) Gastro-Oesophageal Carcinoma which has not responded to a minimum of 2 lines of prior anti-cancer therapy.\n\nTrial Details:\n\nParticipants will be randomly (by chance) allocated to one of two groups: regorafenib or placebo in 2:1 ratio respectively and will not be aware of their group allocation. Regorafenib or matching placebo will be self-administered by participants orally once daily on days 1-21 of each 28 days cycle. Treatment will continue until disease progression or prohibitive toxicity. Participants will be followed up every 2-4 weeks in order to evaluate their progress on the study.', 'Inclusion Criteria': 'Inclusion Criteria\n\nAdults (18 years or over) with metastatic or locally recurrent gastro-oesophageal cancer which:\n\nhas arisen in any primary gastro-oesophageal site (oesophago-gastric junction (GOJ) or stomach); and\nis of adenocarcinoma or undifferentiated carcinoma histology , and\nis evaluable according to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) by computed tomography (CT) scan performed within 21 days prior to randomisation. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrolment; and\nhas failed or been intolerant to a minimum of 2 lines of prior anti-cancer therapy for recurrent/metastatic disease which must have included at least one platinum agent and one fluoropyrimidine analogue.\n\nNote: Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy will be considered as first line treatment where people have relapsed or progressed within 6 months of completing treatment; Radiosensitising chemotherapy given solely for this purpose concurrent with palliative radiation will not be considered as a line of treatment. Ramucirumab monotherapy, or immunotherapy with a checkpoint inhibitor, will be considered a line of treatment.\n\nHER2-positive participants must have received trastuzumab.\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\nAbility to swallow oral medication.\nAdequate bone marrow function (Platelets ≥100x109/L; Absolute Neutrophil Count (ANC) ≥1.5x109/L and Haemoglobin ≥ 9.0g/dL).\nAdequate renal function (Creatinine clearance >50 ml/min) based on either the Cockcroft-Gault formula (Appendix 2), 24-hour urine or Glomerular Filtration Rate (GFR) scan; and serum creatinine ≤1.5 x Upper Limit of Normal (ULN).\nAdequate liver function (Serum total bilirubin ≤1.5 x ULN, and INR ≤ 1.5 x ULN, and Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) ≤2.5 x ULN (≤ 5 x ULN for participants with liver metastases)). Participants being treated with an anti-coagulant, such as warfarin or heparin, will be allowed to participate provided that no prior evidence of an underlying abnormality in these parameters exists.\nAdequate cardiac function (Left Ventricular Ejection Fraction (LVEF) ≥ 50% or above the lower limit of normal (LLN) for the Institution (whichever is lower). Cardiac function should be assessed within 3 months prior to randomisation, but after completion of any anthracycline-containing chemotherapy.\nWilling and able to comply with all study requirements, including treatment, timing, and/or nature of required assessments and follow-up.\nStudy treatment both planned and able to start within 7 days after randomisation (note: subjects randomised on a Friday should commence treatment no earlier than the following Monday).\nSigned, written informed consent.'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic/Locally Recurrent'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT02773524
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{'Official Title': 'A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)\n', 'Brief Summary': 'A randomised phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo)\n', 'Condition': 'Gastro-Oesophageal Cancer\n', 'Detailed Description': 'Purpose:\n\nThe purpose of this Phase III study is to determine if regorafenib improves overall survival in patients with Advanced Gastro-Oesophageal Carcinoma.\n\nWho is it for:\n\nYou may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) Gastro-Oesophageal Carcinoma which has not responded to a minimum of 2 lines of prior anti-cancer therapy.\n\nTrial Details:\n\nParticipants will be randomly (by chance) allocated to one of two groups: regorafenib or placebo in 2:1 ratio respectively and will not be aware of their group allocation. Regorafenib or matching placebo will be self-administered by participants orally once daily on days 1-21 of each 28 days cycle. Treatment will continue until disease progression or prohibitive toxicity. Participants will be followed up every 2-4 weeks in order to evaluate their progress on the study.', 'Inclusion Criteria': 'Inclusion Criteria\n\nAdults (18 years or over) with metastatic or locally recurrent gastro-oesophageal cancer which:\n\nhas arisen in any primary gastro-oesophageal site (oesophago-gastric junction (GOJ) or stomach); and\nis of adenocarcinoma or undifferentiated carcinoma histology , and\nis evaluable according to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) by computed tomography (CT) scan performed within 21 days prior to randomisation. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrolment; and\nhas failed or been intolerant to a minimum of 2 lines of prior anti-cancer therapy for recurrent/metastatic disease which must have included at least one platinum agent and one fluoropyrimidine analogue.\n\nNote: Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy will be considered as first line treatment where people have relapsed or progressed within 6 months of completing treatment; Radiosensitising chemotherapy given solely for this purpose concurrent with palliative radiation will not be considered as a line of treatment. Ramucirumab monotherapy, or immunotherapy with a checkpoint inhibitor, will be considered a line of treatment.\n\nHER2-positive participants must have received trastuzumab.\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\nAbility to swallow oral medication.\nAdequate bone marrow function (Platelets ≥100x109/L; Absolute Neutrophil Count (ANC) ≥1.5x109/L and Haemoglobin ≥ 9.0g/dL).\nAdequate renal function (Creatinine clearance >50 ml/min) based on either the Cockcroft-Gault formula (Appendix 2), 24-hour urine or Glomerular Filtration Rate (GFR) scan; and serum creatinine ≤1.5 x Upper Limit of Normal (ULN).\nAdequate liver function (Serum total bilirubin ≤1.5 x ULN, and INR ≤ 1.5 x ULN, and Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) ≤2.5 x ULN (≤ 5 x ULN for participants with liver metastases)). Participants being treated with an anti-coagulant, such as warfarin or heparin, will be allowed to participate provided that no prior evidence of an underlying abnormality in these parameters exists.\nAdequate cardiac function (Left Ventricular Ejection Fraction (LVEF) ≥ 50% or above the lower limit of normal (LLN) for the Institution (whichever is lower). Cardiac function should be assessed within 3 months prior to randomisation, but after completion of any anthracycline-containing chemotherapy.\nWilling and able to comply with all study requirements, including treatment, timing, and/or nature of required assessments and follow-up.\nStudy treatment both planned and able to start within 7 days after randomisation (note: subjects randomised on a Friday should commence treatment no earlier than the following Monday).\nSigned, written informed consent.'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic/Locally Recurrent'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05270044
|
{'Official Title': 'Adjuvant Encorafenib & Binimetinib vs. Placebo in Fully Resected Stage IIB/C BRAF V600E/K Mutated Melanoma: a Randomized Triple-blind Phase III Study in Collaboration With the EORTC Melanoma Group', 'Brief Summary': 'The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).', 'Condition': 'Melanoma', 'Detailed Description': 'This is a randomized triple-blind placebo-controlled international multicenter phase III superiority clinical trial.\r\n\r\nParticipants with completely resected cutaneous melanoma and documented BRAF V600E/K status by central assay will be randomized 1 to 1 to receive either treatment with encorafenib and binimetinib or their two placebos for 12 months. Patients will be stratified according to the stage of the disease according to AJCC version 8 between:\r\n\r\nstage IIB (i.e., pT3b or pT4a)\r\nstage IIC (i.e., pT4b).\r\nThe long-term evaluation of all endpoints (including information about the occurrence of new treatment-related adverse events, if any) will take place 10 years from the randomization of the last patient.', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nPre-Screening\r\n\r\nMale or female ≥ 18 years of age;\r\nSurgically resected, with tumour free margins, and histologically/pathologically confirmed new diagnosis of stage II (pT3b-pT4bN0) cutaneous melanomaa;\r\nSentinel node (SN) biopsy within 14 weeks from initial diagnosis of melanoma.\r\nSentinel node (SN) staged node negative (pN0);\r\nAvailable tumour sample for central determination of the BRAF V600E/K mutation.\r\nScreening\r\n\r\nMelanoma confirmed centrally to be BRAF V600E/K mutation-positive;\r\nParticipant still free of disease as evidenced by the required baseline imaging and physical/dermatological assessments performed respectively within 6 weeks and 2 weeks before randomization (Day 1);\r\nNo more than 12 weeks elapsed between full surgical resection (including SLNB) and randomization;\r\nRecovered from definitive surgery (e.g., complete wound healing, no uncontrolled wound infections or indwelling drains);\r\nECOG performance status of 0 or 1;\r\nAdequate haematological function as defined as Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L and Hemoglobin\r\n\r\n≥ 9.0 g/dL;\r\n\r\nAdequate renal function as defined as Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min;\r\nAdequate electrolytes, defined as serum potassium and magnesium levels within institutional normal limits;\r\nAdequate hepatic function as defined as Serum total bilirubin ≤ 1.5 x ULN and < 2 mg/dL, Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 2.5 x ULN;\r\nAdequate cardiac function as defined as LVEF ≥ 50% as determined by MUGA scan or echocardiogram and Mean triplicate QTcF value ≤ 480 msec and no history of QT syndrome;\r\nAdequate coagulation function, defined as INR ≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range;\r\nNegative serum β-HCG test (female patient of childbearing potential only) performed within 3 days prior to Day 1;\r\nFemale patients of child-bearing potential and male patients must agree to follow the protocol's contraception guidance during the treatment period and for ≥30 days after last administration."}
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{'Arm - Disease - Stage of Cancer': 'Stage IIB/C '}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05270044
|
{'Official Title': 'Adjuvant Encorafenib & Binimetinib vs. Placebo in Fully Resected Stage IIB/C BRAF V600E/K Mutated Melanoma: a Randomized Triple-blind Phase III Study in Collaboration With the EORTC Melanoma Group', 'Brief Summary': 'The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).', 'Condition': 'Melanoma', 'Detailed Description': 'This is a randomized triple-blind placebo-controlled international multicenter phase III superiority clinical trial.\r\n\r\nParticipants with completely resected cutaneous melanoma and documented BRAF V600E/K status by central assay will be randomized 1 to 1 to receive either treatment with encorafenib and binimetinib or their two placebos for 12 months. Patients will be stratified according to the stage of the disease according to AJCC version 8 between:\r\n\r\nstage IIB (i.e., pT3b or pT4a)\r\nstage IIC (i.e., pT4b).\r\nThe long-term evaluation of all endpoints (including information about the occurrence of new treatment-related adverse events, if any) will take place 10 years from the randomization of the last patient.', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nPre-Screening\r\n\r\nMale or female ≥ 18 years of age;\r\nSurgically resected, with tumour free margins, and histologically/pathologically confirmed new diagnosis of stage II (pT3b-pT4bN0) cutaneous melanomaa;\r\nSentinel node (SN) biopsy within 14 weeks from initial diagnosis of melanoma.\r\nSentinel node (SN) staged node negative (pN0);\r\nAvailable tumour sample for central determination of the BRAF V600E/K mutation.\r\nScreening\r\n\r\nMelanoma confirmed centrally to be BRAF V600E/K mutation-positive;\r\nParticipant still free of disease as evidenced by the required baseline imaging and physical/dermatological assessments performed respectively within 6 weeks and 2 weeks before randomization (Day 1);\r\nNo more than 12 weeks elapsed between full surgical resection (including SLNB) and randomization;\r\nRecovered from definitive surgery (e.g., complete wound healing, no uncontrolled wound infections or indwelling drains);\r\nECOG performance status of 0 or 1;\r\nAdequate haematological function as defined as Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L and Hemoglobin\r\n\r\n≥ 9.0 g/dL;\r\n\r\nAdequate renal function as defined as Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min;\r\nAdequate electrolytes, defined as serum potassium and magnesium levels within institutional normal limits;\r\nAdequate hepatic function as defined as Serum total bilirubin ≤ 1.5 x ULN and < 2 mg/dL, Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 2.5 x ULN;\r\nAdequate cardiac function as defined as LVEF ≥ 50% as determined by MUGA scan or echocardiogram and Mean triplicate QTcF value ≤ 480 msec and no history of QT syndrome;\r\nAdequate coagulation function, defined as INR ≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range;\r\nNegative serum β-HCG test (female patient of childbearing potential only) performed within 3 days prior to Day 1;\r\nFemale patients of child-bearing potential and male patients must agree to follow the protocol's contraception guidance during the treatment period and for ≥30 days after last administration."}
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{'Arm - Disease - Stage of Cancer': 'Stage IIB/C '}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT03981614
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{'Official Title': 'Combination of MEK Inhibitor Binimetinib and CDK4/6 Inhibitor Palbociclib in KRAS and NRAS Mutant Metastatic Colorectal Cancers\n', 'Brief Summary': 'This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Binimetinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving binimetinib and palbociclib may work better compared to TAS-102 alone in treating patients with colorectal cancer.\n', 'Condition': 'Metastatic Colorectal Carcinoma\nStage IV Colorectal Cancer AJCC v8\nStage IVA Colorectal Cancer AJCC v8\nStage IVB Colorectal Cancer AJCC v8\nStage IVC Colorectal Cancer AJCC v8\nUnresectable Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. The primary objective is to compare the progression-free survival (PFS) between those randomized to palbociclib/binimetinib and those randomized to trifluridine and tipiracil hydrochloride (TAS-102) in patients with refractory KRAS- or NRAS-mutant metastatic colorectal cancer (CRC).\n\nSECONDARY OBJECTIVES:\n\nI. To compare the overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria between those randomized to palbociclib/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nII. To compare the overall survival (OS) between those randomized to palbociclib/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nIII. To determine the safety and tolerability of the recommended phase II dose of palbociclib in combination with binimetinib in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nCORRELATIVE RESEARCH OBJECTIVES:\n\nI. To determine the tumor mutational profiles that characterize groups of patients that predict for response or resistance to combination of palbociclib/binimetinib.\n\nII. To determine the correlation between circulating tumor deoxyribonucleic acid (DNA) and tumor response or resistance to therapy with palbociclib/binimetinib or TAS-102.\n\nIII. To determine the association between Consensus Molecular Subtype based on gene expression profiling and response or resistance to combination of palbociclib/binimetinib.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM A: Patients receive binimetinib orally (PO) twice daily (BID) on days 1-28 and palbociclib PO once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.\n\nARM B: Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A.\n\nAfter completion of study treatment, patients are followed up within 30-37 days and then every 12 weeks for up to 24 months.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistological confirmation of colorectal cancer that is metastatic and/or unresectable\nDocumented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory\nMeasurable disease\nEastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\nPreviously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy\nAbsolute neutrophil count (ANC) >= 1.5 x 10^9/L (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nPlatelet count >= 75 x 10^9/L without transfusions (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nHemoglobin (Hgb) >= 9 g/dL (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nTotal bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nAspartate transaminase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nNegative serum beta-human chorionic gonadotropin (B-HCG) pregnancy test done =< 7 days prior to registration/randomization for women of childbearing potential only\nAble to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications\nAble and willing to provide informed written consent and able to comply with protocol requirement\nAble and willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nNOTE: During the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up\nWilling to provide blood and tissue samples for mandatory correlative research purposes\nPatient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)\nCROSSOVER INCLUSION CRITERIA: Histological confirmation of colorectal cancer that is metastatic and/or unresectable\nCROSSOVER INCLUSION CRITERIA: Documented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a CLIA-certified laboratory\nCROSSOVER INCLUSION CRITERIA: Measurable disease\nCROSSOVER INCLUSION CRITERIA: ECOG performance status (PS) of 0 or 1\nCROSSOVER INCLUSION CRITERIA: Previously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy\nCROSSOVER INCLUSION CRITERIA: ANC >= 1.5 x 10^9/L (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Platelet count >= 75 x 10^9/L without transfusion (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Hgb >= 9 g/dL (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Total bilirubin =< 1.5 x ULN (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: AST and ALT =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Negative serum beta-HCG pregnancy test done =< 7 days prior to re-registration for women of childbearing potential only\nCROSSOVER INCLUSION CRITERIA: Able to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications\nCROSSOVER INCLUSION CRITERIA: Able and willing to provide informed written consent and able to comply with protocol requirements\nCROSSOVER INCLUSION CRITERIA: Able and willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nNOTE: During the Active Monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up\nCROSSOVER INCLUSION CRITERIA: Willing to provide blood samples for mandatory correlative research purposes\nCROSSOVER INCLUSION CRITERIA: Patient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT03981614
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{'Official Title': 'Combination of MEK Inhibitor Binimetinib and CDK4/6 Inhibitor Palbociclib in KRAS and NRAS Mutant Metastatic Colorectal Cancers\n', 'Brief Summary': 'This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Binimetinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving binimetinib and palbociclib may work better compared to TAS-102 alone in treating patients with colorectal cancer.\n', 'Condition': 'Metastatic Colorectal Carcinoma\nStage IV Colorectal Cancer AJCC v8\nStage IVA Colorectal Cancer AJCC v8\nStage IVB Colorectal Cancer AJCC v8\nStage IVC Colorectal Cancer AJCC v8\nUnresectable Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. The primary objective is to compare the progression-free survival (PFS) between those randomized to palbociclib/binimetinib and those randomized to trifluridine and tipiracil hydrochloride (TAS-102) in patients with refractory KRAS- or NRAS-mutant metastatic colorectal cancer (CRC).\n\nSECONDARY OBJECTIVES:\n\nI. To compare the overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria between those randomized to palbociclib/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nII. To compare the overall survival (OS) between those randomized to palbociclib/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nIII. To determine the safety and tolerability of the recommended phase II dose of palbociclib in combination with binimetinib in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nCORRELATIVE RESEARCH OBJECTIVES:\n\nI. To determine the tumor mutational profiles that characterize groups of patients that predict for response or resistance to combination of palbociclib/binimetinib.\n\nII. To determine the correlation between circulating tumor deoxyribonucleic acid (DNA) and tumor response or resistance to therapy with palbociclib/binimetinib or TAS-102.\n\nIII. To determine the association between Consensus Molecular Subtype based on gene expression profiling and response or resistance to combination of palbociclib/binimetinib.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM A: Patients receive binimetinib orally (PO) twice daily (BID) on days 1-28 and palbociclib PO once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.\n\nARM B: Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A.\n\nAfter completion of study treatment, patients are followed up within 30-37 days and then every 12 weeks for up to 24 months.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistological confirmation of colorectal cancer that is metastatic and/or unresectable\nDocumented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory\nMeasurable disease\nEastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\nPreviously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy\nAbsolute neutrophil count (ANC) >= 1.5 x 10^9/L (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nPlatelet count >= 75 x 10^9/L without transfusions (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nHemoglobin (Hgb) >= 9 g/dL (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nTotal bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nAspartate transaminase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nNegative serum beta-human chorionic gonadotropin (B-HCG) pregnancy test done =< 7 days prior to registration/randomization for women of childbearing potential only\nAble to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications\nAble and willing to provide informed written consent and able to comply with protocol requirement\nAble and willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nNOTE: During the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up\nWilling to provide blood and tissue samples for mandatory correlative research purposes\nPatient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)\nCROSSOVER INCLUSION CRITERIA: Histological confirmation of colorectal cancer that is metastatic and/or unresectable\nCROSSOVER INCLUSION CRITERIA: Documented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a CLIA-certified laboratory\nCROSSOVER INCLUSION CRITERIA: Measurable disease\nCROSSOVER INCLUSION CRITERIA: ECOG performance status (PS) of 0 or 1\nCROSSOVER INCLUSION CRITERIA: Previously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy\nCROSSOVER INCLUSION CRITERIA: ANC >= 1.5 x 10^9/L (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Platelet count >= 75 x 10^9/L without transfusion (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Hgb >= 9 g/dL (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Total bilirubin =< 1.5 x ULN (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: AST and ALT =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Negative serum beta-HCG pregnancy test done =< 7 days prior to re-registration for women of childbearing potential only\nCROSSOVER INCLUSION CRITERIA: Able to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications\nCROSSOVER INCLUSION CRITERIA: Able and willing to provide informed written consent and able to comply with protocol requirements\nCROSSOVER INCLUSION CRITERIA: Able and willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nNOTE: During the Active Monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up\nCROSSOVER INCLUSION CRITERIA: Willing to provide blood samples for mandatory correlative research purposes\nCROSSOVER INCLUSION CRITERIA: Patient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)'}
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{'Arm - Disease - Stage of Cancer': 'Metastatic'}
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT05920356
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{'Official Title': 'A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)', 'Brief Summary': 'The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.', 'Condition': 'Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing\r\nNo history of systemic anticancer therapy in metastatic/non-curable settings\r\nEastern Cooperative Oncology Group (ECOG) ≤ 1'}
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{'Arm - Disease - Stage of Cancer': 'Stage IV, Advanced Stage IIIB, Stage IIIIC'}
| 0
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
|
NCT05920356
|
{'Official Title': 'A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)', 'Brief Summary': 'The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.', 'Condition': 'Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing\r\nNo history of systemic anticancer therapy in metastatic/non-curable settings\r\nEastern Cooperative Oncology Group (ECOG) ≤ 1'}
|
{'Arm - Disease - Stage of Cancer': 'Stage IV, Advanced Stage IIIB, Stage IIIIC'}
| 0
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Stage of Cancer Extraction Guideline
1. Review the “arms data” and identify the stage of cancer from the clinical trial arm.
2. Rely only on "arms data" to identify the stage of cancer. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned.
3. Make sure to extract only the stage of cancer information.
4. Avoid any other additional context.
5. Return just the stage of cancer. Do not write a para.
6. Refer to these examples for formatting: Return Stage of Cancer - Advanced, Stage IV
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NCT02642042
|
{'Official Title': 'A Phase II Trial of Trametinib With Docetaxel in Patients With KRAS Mutation Positive Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease Following One or Two Prior Systemic Therapies', 'Brief Summary': 'This phase II trial studies how well trametinib and docetaxel work in treating patients with stage IV KRAS mutation positive non-small cell lung cancer or cancer that has come back. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trametinib with docetaxel may work better in treating non-small cell lung cancer.', 'Condition': 'Recurrent Lung Non-Small Cell Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVES:\r\n\r\nI. To evaluate the response rate (confirmed and unconfirmed) to trametinib plus docetaxel in the entire study population of Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive non-small cell lung cancer (NSCLC) patients following one or two prior systemic therapies.\r\n\r\nSECONDARY OBJECTIVES:\r\n\r\nI. To evaluate if trametinib plus docetaxel is consistent with promise of activity measured by the response rate in G12C KRAS mutation positive NSCLC patients following one or two prior systemic therapies.\r\n\r\nII. To assess the response rate of this combination in non-G12C KRAS mutation positive NSCLC patients.\r\n\r\nIII. To assess progression-free survival within the G12C and non-G12C KRAS positive subgroups and the entire study population.\r\n\r\nIV. To evaluate the toxicity of the regimen. V. To assess overall survival within G12C positive patients, non-G12C positive patients, and the entire study population.\r\n\r\nTRANSLATIONAL MEDICINE OBJECTIVES:\r\n\r\nI. To evaluate the response rates in the presence of comutations p53 and LKB1. II. To bank specimens for future research.\r\n\r\nOUTLINE:\r\n\r\nPatients receive trametinib orally (PO) on days 1-21. Patients also receive docetaxel intravenously (IV) on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\r\n\r\nAfter completion of study treatment, patients are followed up every 6 months for 3 years.\r\n\r', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nDISEASE RELATED CRITERIA: Patients must have pathologically confirmed KRAS mutation (at codon 12, 13 and 61) positive non-small cell lung cancer (NSCLC) that is stage IV or recurrent; the specific subtype of KRAS mutation must be known; KRAS mutation testing must have been performed in a Clinical Laboratory Improvement Act (CLIA) certified laboratory; CLIA certified commercially available tests are acceptable\r\nDISEASE RELATED CRITERIA: Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI) within 28 days prior to registration; the CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality; non-measurable disease must be assessed within 42 days prior to registration; all known sites of disease must be assessed and documented on the baseline tumor assessment form (Response Evaluation Criteria in Solid Tumors [RECIST 1.1])\r\nDISEASE RELATED CRITERIA: Patients must not have known brain metastases, leptomeningeal carcinomatosis or spinal cord compression unless: (1) metastases have been locally treated (including stereotactic body radiation therapy [SBRT], whole brain radiotherapy [WBRT], and surgical resection) and have remained clinically controlled and asymptomatic for at least 14 days following treatment and prior to registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 2 days prior to registration\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients must have documented progressive cancer following at least one but no more than two prior regimens of systemic therapy for lung cancer, one of which must have been platinum based combination chemotherapy; treatment with an immune therapy or targeted therapy for advanced disease will be considered a separate regimen and will count toward the prior regimens; maintenance therapy will not be counted as a separate regimen; adjuvant chemotherapy or chemotherapy administered as part of concurrent chemotherapy and radiation therapy for the treatment of lung cancer will not count as a prior regimen of systemic therapy as long as recurrence of patient\'s lung cancer occurred more than 12 months after the last day of chemotherapy\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have received any chemotherapy, biologic agent, or any investigational agent within 14 days prior to registration. Patients must have recovered from any adverse events to Common Terminology Criteria for Adverse Events (CTCAE) grade 0-1 prior to registration\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Prior treatment with an anti-PD-1 or anti-PDL1 is not required\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have received prior docetaxel; patients must not have received therapy with a drug known to be either a mitogen-activated protein kinase (MEK) inhibitor or a phosphatidylinositol 3 kinase (PI3K)/v-akt murine thymoma viral oncogene homolog 1 (AKT)/mammalian target of rapamycin (mTOR) pathway inhibitor\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients must have recovered from any adverse effects from prior therapy (except alopecia) to =< CTCAE grade 1 prior to registration\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients may have had prior radiation therapy as long as it has not affected greater than 25% of the bone marrow and at least one measurable lesion is outside the area of prior radiation; at least 7 days must have elapsed since last radiation treatment; patients must have recovered from any adverse events from prior radiation therapy to =< CTCAE grade 1\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have had a major surgery within 28 days prior to registration; patients must have recovered from any adverse effects of prior surgery to the satisfaction of the treating physician; biopsies and central IV access placement are not considered major surgery\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Because the composition, pharmacokinetics (PK), and metabolism of many herbal supplements are unknown, the concurrent use of all herbal supplements is prohibited during the study (including but not limited to St. John\'s wort, kava, ephedra [ma huang], ginko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)\r\nCLINICAL/LABORATORY CRITERIA: Patients must have Zubrod performance status of 0-2\r\nCLINICAL/LABORATORY CRITERIA: Absolute neutrophil count (ANC) >= 1500/mcL; these results must be obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Platelet count >= 100,000/mcL; these results must be obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Hemoglobin >= 9 grams/dl; these results must be obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN); these results must be obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (or =< 5 x IULN for patients with known liver metastases); these results must be obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Serum creatinine =< 1.5 x IULN OR measured or calculated creatinine clearance >= 40 mL/min; this result must have been obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Patients must be able to swallow oral medications and must not have a gastro-intestinal disorder with diarrhea as a major symptom or that may alter absorption such as malabsorption syndromes or gastric resection\r\nCLINICAL/LABORATORY CRITERIA: Patient must not have prior history of interstitial lung disease or pneumonitis\r\nCLINICAL/LABORATORY CRITERIA: Patients must not have history of significant co-morbid illness inclusive of but not restricted to New York Heart Association class II, congestive cardiac failure, uncontrolled hypertension, history of myocardial infarction, unstable angina, coronary angioplasty, stenting or cerebrovascular accident within 6 months prior to registration or any other illness that in the assessment of the treating physician would compromise the ability of the patient to participate in this study\r\nCLINICAL/LABORATORY CRITERIA: Patients must have corrected QT (QTc) interval =< 480 msec (using the Bazett\'s formula) on electrocardiogram (ECG) performed within 42 days prior to registration; history or evidence of current clinically significant uncontrolled arrhythmias are not eligible; however, patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible; patients must not have atrial fibrillation > grade 2 on the screening ECG; patients with CTCAE grade 1-2 atrial fibrillation on their screening ECG must have a second ECG performed prior to registration and more than 30 days from the screening ECG (either before or after) with the most recent ECG showing stable or improving grade of atrial fibrillation\r\nCLINICAL/LABORATORY CRITERIA: Patients must have a left ventricular ejection fraction (LVEF) >= institutional lower limit of normal (ILLN) by echocardiography (ECHO) or multi-gated acquisition scan (MUGA) within 42 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Patients must not have untreated or unresolved retinopathy or have a history (or current evidence) of retinal vein occlusion determined by an ophthalmology exam within 42 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Patients must not have an immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients, or to dimethyl sulfoxide (DMSO) or other agents used in the study\r\nCLINICAL/LABORATORY CRITERIA: Patients must not have a known history of active hepatitis B or C infection (defined as presence of hepatitis [Hep] B surface antigen [sAg] and/or Hep B deoxyribonucleic acid [DNA] and/or Hep C ribonucleic acid [RNA]); patients must not have a known history of human immunodeficiency virus (HIV) seropositivity\r\nCLINICAL/LABORATORY CRITERIA: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years; patients with localized prostate cancer who are being followed by an active surveillance program are also eligible\r\nCLINICAL/LABORATORY CRITERIA: Patients must not be pregnant or nursing due to the risk of fetal or nursing infant harm; women/men of reproductive potential must have agreed to use an effective contraceptive method (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation and for 4 months after the last dose of the drug; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures\r\nSPECIMEN SUBMISSION CRITERIA: Patients must be offered optional participation in banking of specimens for future research\r\nREGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines\r\nREGULATORY CRITERIA: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system'}
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{'Arm - Disease - Stage of Cancer': ' Stage IV'}
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