Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments folfox regimen, fluorouracil, leucovorin calcium, oxaliplatin, xelox regimen, capecitabine
Phase phase 3
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 XELOX 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)
folfox regimen
Given IV
fluorouracil
Given IV
leucovorin calcium
Given IV
oxaliplatin
Given IV
xelox regimen
capecitabine
oral
(Experimental)
Patients receive modified FOLFOX 6 or XELOX as in arm I. Treatment repeats every 14 days for 12 courses (6 months)or regarding XELOX every 21 days for 8 courses (6 month).
folfox regimen
Given IV
fluorouracil
Given IV
leucovorin calcium
Given IV
oxaliplatin
Given IV
xelox regimen
capecitabine
oral

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Overall survival
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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR).