At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 1,987 enrolled

Drug / intervention

5-Fluorouracil +2 moredrug

Likely dose

Capecitabine 1250 mg/m² orally twice daily on days 1-14 every 21 days OR 5-Fluorouracil 425 mg/m² IV daily days 1-5 with Leucovorin 20 mg/m² IV daily days 1-5 every 28 daysAI-extracted

Key inclusion· 3

✓Age 18-75 years
✓Histologically confirmed colon cancer
✓Curative resection of the tumor within 8 weeks before study initiation

Key exclusion· 1

✕Prior chemotherapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00009737

NCT00009737Phase 3Completed

Compare CT.gov

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

Hoffmann-La Roche·interventional·Posted Mar 17, 2004·Updated Jun 22, 2016

In Brief

A Phase 3 clinical trial evaluating 5-Fluorouracil, Leucovorin, and 1 other intervention for Colorectal Cancer. Completed, enrolled 1,987 participants across 133 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsColorectal Cancer

CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Germany, Israel, Italy, Portugal, Spain, Switzerland, United Kingdom, United States

Collaborators--

Timeline

Phase 3CompletedFinished

19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartNov 1998

First PostedMar 2004

Primary CompletionApr 2004

TodayJul 2026

First PostedMar 17, 2004

Enrollment StartNov 1, 1998

Primary CompletionApr 1, 2004

TodayJul 2, 2026

Enrollment to primary: 5.4 yearsPosted 22.3 years ago

Interventions

5-Fluorouracildrug

425mg/m2 iv daily from day 1 to day 5 every 28 days.

Leucovorindrug

20mg/m2 iv daily from day 1 to day 5 every 28 days.

Capecitabine [Xeloda]drug

1250mg/m2 po bid on days 1-14 every 21 days.