A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer, Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | November 1998 |
| End Date: | March 2008 |
A Randomized, Open-label Study Comparing Adjuvant Chemotherapy With Xeloda, or 5-fluorouracil Plus Leucovorin, on Disease-free and Overall Survival in Patients Who Have Had Surgery for Colon Cancer
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-FU 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.
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-FU 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.
Inclusion Criteria:
- adult patients 18-75 years of age;
- histologically confirmed colon cancer with potentially curative resection of the
tumor within 8 weeks before study initiation.
Exclusion Criteria:
- previous chemotherapy
We found this trial at
18
sites
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