Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Federation Francophone de Cancerologie Digestive
OBJECTIVES: Primary * 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. Secondary * 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 years. PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
Age
18–74
Sex
ALL
Healthy volunteers
Not accepted
