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
- 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.
- 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
- To evaluate the safety profiles of the treatment groups
- 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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival (defined as local, regional, or distant relapse; second primary colorectal cancer; or death from any cause)
3 years after randomisation
Thierry Andre, MD
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
France: Agence Nationale de Sécurité du Médicament et des produits de santé