Combination Chemotherapy for 3 Months or 6 Months in Treating Patients With Stage III Colon Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Drug: FOLFOX regimenDrug: CAPOX
- Registration Number
- NCT00958737
- Lead Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II FOLFOX regimen Patients receive modified FOLFOX 6 or CAPOX as in arm I. Treatment repeats every 14 days for 12 courses (6 months)or regarding CAPOX every 21 days for 8 courses (6 month). Arm I FOLFOX regimen Patients receive modified FOLFOX 6 comprising oxaliplatin IV 85 mg/m² 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). Patients receive CAPOX comprising oxaliplatin IV 130 mg/m² over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which will be administered orally at a dose of 1000 mg/m2 twice-daily (equivalent to a total daily dose of 2000 mg/m2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) Arm I CAPOX Patients receive modified FOLFOX 6 comprising oxaliplatin IV 85 mg/m² 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). Patients receive CAPOX comprising oxaliplatin IV 130 mg/m² over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which will be administered orally at a dose of 1000 mg/m2 twice-daily (equivalent to a total daily dose of 2000 mg/m2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) Arm II CAPOX Patients receive modified FOLFOX 6 or CAPOX as in arm I. Treatment repeats every 14 days for 12 courses (6 months)or regarding CAPOX every 21 days for 8 courses (6 month).
- Primary Outcome Measures
Name Time Method Disease-free survival (DFS) 3 years after randomisation DFS, defined as the time from random assignment to relapse or death, whichever occurred first. Secondary colorectal cancers were regarded as DFS events, whereas noncolorectal cancers were disregarded in the analysis.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Death from randomization; up to 7 years after randomization The time from the date of randomization to the date of death from any cause
Safety profile Assessed up to 6 months after randomisation All grade and severe toxicities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Treatment compliance Until 3 months or 6 months (according randomization arm) duration, dose intensity, and dose in mg/m2
Trial Locations
- Locations (1)
GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie
🇫🇷Paris, France