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An Open-Label Randomized Phase III Study Comparing Xeloda (Capecitabine) With IV Bolus 5-Fluorouracil in Combination With Low-Dose Leucovorin as Adjuvant Chemotherapy in Patients Who Underwent Surgery for Dukes C 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-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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Fountain Valley, California, United States
Los Angeles, California, United States
Hartford, Connecticut, United States
Miami, Florida, United States
Decatur, Georgia, United States
Columbia, Missouri, United States
St Louis, Missouri, United States
Albany, New York, United States
Start Date
November 1, 1998
Primary Completion Date
April 1, 2004
Completion Date
April 1, 2004
Last Updated
June 22, 2016
1,987
ACTUAL participants
5-Fluorouracil
DRUG
Leucovorin
DRUG
Capecitabine [Xeloda]
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT06696768
NCT04704661
Data Source & Attribution
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