A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer

Completed · Phase 3

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT00009737

Run by

Hoffmann-La Roche

People needed

1987

Starts

1998-11-01

Expected to finish

2004-04-01

Last updated by the study team

2016-06-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients 18-75 years of age;
• histologically confirmed colon cancer with potentially curative resection of the tumor within 8 weeks before study initiation.

You may not qualify if…

• previous chemotherapy

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Fountain Valley, California, United States
• Study site — Los Angeles, California, United States
• Study site — Hartford, Connecticut, United States
• Study site — Miami, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Columbia, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Albany, New York, United States
• Study site — Buffalo, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Tyler, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Adelaide, Australia
• Study site — Bendigo, Australia
• Study site — Brisbane, Australia
• Study site — Fitzroy, Australia
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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