A UKCCCR Study of Adjuvant Chemotherapy for Colorectal Cancer
- Compare all-cause mortality in patients with resected colorectal cancer treated with
adjuvant chemotherapy with L-leucovorin and fluorouracil vs observation.
- Compare the recurrence rates in patients treated with this regimen vs observation.
- Compare the effectiveness of a monthly 5-day schedule vs a once weekly schedule of
L-leucovorin and fluorouracil in this patient population.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to
receive adjuvant chemotherapy (arm I) or undergo observation only (arm II).
- Arm I: Within 12 weeks of surgery, patients receive L-leucovorin IV followed by
fluorouracil IV on days 1-5 every 4 weeks for 6 courses. Alternatively, patients may
receive L-leucovorin IV followed by fluorouracil IV on day 1 weekly for 30 weeks.
- Arm II: Patients undergo observation. Patients are followed annually.
PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per arm) will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Norman Williams, MD
Royal London Hospital
United States: Federal Government