prompt
stringclasses 1
value | id
stringlengths 11
11
| instruction
stringlengths 710
15.1k
| output
stringlengths 47
105
| Train
int64 0
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
|
NCT03874884
|
{'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."}
|
{'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
|
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'}
|
{'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
|
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'}
|
{'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.'}
|
{'Arm - Disease - Stage of Cancer': 'Newly Diagnosed, Stage III, Stage IV, 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
|
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.'}
|
{'Arm - Disease - Stage of Cancer': 'Newly Diagnosed, Stage III, Stage IV, 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
|
NCT03936270
|
{'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)."}
|
{'Arm - Disease - Stage of Cancer': 'High-Grade, Metastatic, Locoregional, Locally 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
|
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.'}
|
{'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
|
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.'}
|
{'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
|
NCT04590599
|
{'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)."}
|
{'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
|
NCT04590599
|
{'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)."}
|
{'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
|
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.'}
|
{'Arm - Disease - Stage of Cancer': 'Locally Advanced, 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
|
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.'}
|
{'Arm - Disease - Stage of Cancer': 'Locally Advanced, 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
|
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.'}
|
{'Arm - Disease - Stage of Cancer': 'Locally Advanced, 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
|
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)."}
|
{'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
|
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)."}
|
{'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
|
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'}
|
{'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
|
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.'}
|
{'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
|
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.'}
|
{'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
|
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.'}
|
{'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
|
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"}
|
{'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
|
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"}
|
{'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.'}
|
{'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.'}
|
{'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)'}
|
{'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
|
NCT04634877
|
{'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."}
|
{'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
|
NCT04634877
|
{'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."}
|
{'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
|
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'}
|
{'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
|
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'}
|
{'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
|
NCT01068249
|
{'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.'}
|
{'Arm - Disease - Stage of Cancer': 'Advanced'}
| 0
|
End of preview. Expand
in Data Studio
No dataset card yet
- Downloads last month
- 9