Conditions: Colorectal Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1987
Healthy volunteers: no

Brief summary:
This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-fluorouracil 425mg/m2 iv daily from day 1 to day 5 every 28 days. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Detailed description:

Arms:
arm 1: Participants received capecitabine 1250 milligram per square meter (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks). arm 2: Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).

Interventions: intervention 1: 5-Fluorouracil intervention 2: Leucovorin intervention 3: Capecitabine [Xeloda]
Intervention descriptions: intervention 1: 425mg/m2 iv daily from day 1 to day 5 every 28 days. intervention 2: 20mg/m2 iv daily from day 1 to day 5 every 28 days. intervention 3: 1250mg/m2 po bid on days 1-14 every 21 days.

Protocol document: