Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence
- Compare the effect of leucovorin calcium and fluorouracil with or without irinotecan on
the 3 year survival rate and overall survival of patients with resected node positive
colon cancer at high risk of recurrence.
- Compare toxicities of these regimens in these patients.
- Compare quality of life of these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, disease type (occlusion vs perforation vs N2 only), delay between surgery and
chemotherapy (28 days or less vs over 28 days), and age (under 65 vs 65 and over). Patients
are randomized to one of two treatment arms.
- Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22
hours on days 1 and 2.
- Arm II: Patients receive irinotecan IV over 90 minutes on day 1 followed by leucovorin
calcium and fluorouracil as in arm I.
Treatment repeats every 14 days for up to 12 courses in the absence of disease progression
or unacceptable toxicity.
Quality of life is assessed before treatment, after 6 and 12 courses, and then at 1 year.
Patients are followed every 3 months for 2 years, then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study
within 3 years.
Allocation: Randomized, Primary Purpose: Treatment
Marc Ychou, MD, PhD
Centre Val d'Aurelle - Paul Lamarque
United States: Federal Government