Combination Chemotherapy for 3 Months or 6 Months in Treating Patients With Stage III Colon Cancer
This trial is active, not recruiting.
|Treatments||folfox regimen, fluorouracil, leucovorin calcium, oxaliplatin, xelox regimen, capecitabine|
|Sponsor||Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)|
|Start date||April 2009|
|End date||May 2016|
|Trial size||2000 participants|
|Trial identifier||NCT00958737, CDR0000647466, EU-20957, EUDRACT-2009-010384-16, FRE-GERCOR-C09-1-IDEA|
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving more than one drug (combination chemotherapy) is more effective when given for 3 months or 6 months in treating patients with colon cancer.
PURPOSE: This randomized phase III trial is studying giving combination chemotherapy for 3 months to see how well it works compared with giving combination chemotherapy for 6 months in treating patients with stage III colon cancer.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Disease-free survival (defined as local, regional, or distant relapse; second primary colorectal cancer; or death from any cause)
time frame: 3 years after randomisation
time frame: death from randomization
Toxicity according to NCI CTCAE version 3.0
time frame: each cycle
Total cumulative dose received vs planned dose
time frame: at the end of treatment
Incidence and timing of dose reductions and/or modifications of time
time frame: at the end of treatment
Male or female participants from 18 years up to 120 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed colon cancer - Tumor location > 12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery (high rectum) - AJCC/UICC stage III disease - Adenocarcinoma - No evidence of metastatic disease (including presence of tumor cells in ascites or peritoneal carcinomatosis resected "en bloc") - Undergone curative surgery for colon cancer within the past 8 weeks - No gross, macroscopic, or microscopic evidence of residual disease (R1 or R2 resections) after surgery - Carcinoembryonic antigen ≤ 10 ng/mL (2 times normal) PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and up to 1 month after completion of study treatment - Willing and able to comply with study requirements - No clinically relevant cardiovascular disease (ischemic myocardial infarction in the past year and/or unstable ischemic cardiopathy) - No other malignancies within the past 5 years except for curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix - No history or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ CTCAE v.3.0 grade 1 - No known hypersensitivity reaction to any of the components of study treatments - Registered in a national health care system (CMU included) PRIOR CONCURRENT THERAPY: - See Disease Characteristics - More than 28 days since prior treatment, no concurrent treatment, and no treatment while the patient is disease-free during study follow-up with another investigational drug - No concurrent treatment or treatment while the patient is disease-free during study follow-up with other cytotoxic agents, or active or passive immunotherapy for colon cancer
|Official title||A Phase III Randomized Trial Investigating the Duration of Adjuvant Therapy(3 Versus 6 Months) With the Modified FOLFOX 6 or XELOX Regimens for Patients With Stage III Colon Cancer|
|Principal investigator||Thierry Andre, MD|
|Description||OBJECTIVES: Primary Objective - To assess whether a 3-month modified FOLFOX 6 or XELOX treatment is not inferior to a 6-month modified FOLFOX 6 or XELOX treatment in terms of disease free survival (DFS) in patients with radically resected stage III colon cancer. Secondary Objectives - To assess whether 3-month modified FOLFOX 6 (6 cycles) or XELOX (4 cycles) treatment is not inferior to 6-month modified FOLFOX 6 (12 cycles) or XELOX (8 cycles) treatment in terms of overall survival (OS) in patients with radically resected stage III colon cancer - To evaluate the safety profiles of the treatment groups Tertiary Objectives - For patients who signed a specific informed consent, blood and tumour tissue samples will be stored, registered, and centralized in a data bank for translational research projects that will be further determined according to the literature and scientific knowledge at the time of the end of inclusion. (exploratory) - An economic evaluation at the country level will be conducted alongside the clinical evaluation. (exploratory) OUTLINE: This is a multicenter study. Patients are stratified according to center, T stage (1 or 2 vs 3 vs 4), N stage (1 vs 2), performance status (0 vs 1 vs 2), and age (< 70 years vs ≥ 70 years). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive modified FOLFOX 6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. Treatment repeats every 14 days for 6 courses (3 months). - Arm II: Patients receive modified FOLFOX 6 as in arm I. Treatment repeats every 14 days for 12 courses (6 months). Blood and tumor samples may be collected at baseline for pharmacogenetic and other analyses. After completion of study treatment, patients are followed up every 6 months for 8 years.|
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