Adjuvant Treatment of Fully Resected Stage III Colon Cancer With FOLFOX-4 Versus FOLFOX-4 Plus Cetuximab
- Compare the disease-free survival rates in patients with completely resected stage III
colon cancer treated with adjuvant oxaliplatin, leucovorin calcium, and fluorouracil
with vs without cetuximab.
- Compare the 3-year disease-free survival rate and 5-year overall survival rate in
patients treated with these regimens.
- Compare the overall survival of patients treated with these regimens.
- Compare the treatment compliance of patients treated with these regimens.
- Determine the prognostic factors and markers predictive for relapse and/or treatment
efficacy in patients treated with these regimens.
- Compare the safety of these regimens in these patients.
OUTLINE: This is an open-label, randomized, controlled, multicenter study. Patients are
stratified according to obstruction/perforation status (no obstruction and no perforation vs
obstruction and/or perforation), N stage (N1 vs N2), and T stage (T1-3 vs T4). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV
over 2 hours and fluorouracil IV continuously over 22 hours on days 1 and 2.
- Arm II: Patients receive chemotherapy as in arm I plus cetuximab IV over 1-2 hours on
days 1 and 8.
In both arms, treatment repeats every 14 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for approximately 5
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Julien Taieb, MD
Austria: Agency for Health and Food Safety