5-Fluorouracil-Leucovorin With or Without Carboplatin as Adjuvant Treatment for Primary Dukes B2-C Colon Cancer; Chronomodulated Versus Standard Administration. A Multicenter Randomized Phase III Trial of the GRECCR-Belgium (Study 03).
- Compare the disease-free survival of patients with completely resected stage IIB or III
colon cancer treated with adjuvant chronomodulated vs standard schedule fluorouracil
and leucovorin calcium with or without carboplatin.
- Compare the overall survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Determine the dose intensities of fluorouracil and carboplatin in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center and disease stage (IIB vs III). Patients are randomized to 1 of 4
- Arm I (standard schedule): Patients receive fluorouracil (5-FU) IV continuously and
leucovorin calcium (CF) IV on days 1 and 2.
- Arm II (standard + carboplatin schedule): Patients receive 5-FU and CF as in arm I plus
carboplatin IV on day 1.
- Arm III (chronomodulated schedule): Patients receive 5-FU IV continuously and CF IV
continuously on days 1-4.
- Arm IV (chronomodulated + carboplatin schedule): Patients receive 5-FU and CF as in arm
III plus carboplatin IV continuously on days 1-4.
Quality of life is assessed.
Treatment in all arms repeats every 14 days for up to 9 courses in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 660-800 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Christian N.J. Focan, MD, PhD
United States: Federal Government