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

ClinicalTrials.gov ID: NCT00009737

Public ClinicalTrials.gov record NCT00009737. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 11, 2026, 12:14 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT00009737
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 1,987 participants

Conditions and interventions

Conditions

Colorectal Cancer

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 31, 1998
Primary completion: Mar 31, 2004
Completion: Mar 31, 2004
Last update posted: Jun 21, 2016

1998 – 2004

United States locations

U.S. sites: 17
U.S. states: 13
U.S. cities: 17

Facility	City	State	ZIP	Site status
Not listed	Birmingham	Alabama	35294	—
Not listed	Phoenix	Arizona	85012	—
Not listed	Fountain Valley	California	92708	—
Not listed	Los Angeles	California	90089	—
Not listed	Hartford	Connecticut	06102-5037	—
Not listed	Miami	Florida	33176	—
Not listed	Decatur	Georgia	30033	—
Not listed	Columbia	Missouri	65203	—
Not listed	St Louis	Missouri	63141	—
Not listed	Albany	New York	12208	—
Not listed	Buffalo	New York	14263	—
Not listed	Cleveland	Ohio	44195	—
Not listed	Philadelphia	Pennsylvania	19104	—
Not listed	Nashville	Tennessee	37203-1632	—
Not listed	Austin	Texas	78705	—
Not listed	Tyler	Texas	75701	—
Not listed	Seattle	Washington	98195	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 116 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00009737, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 21, 2016 · Synced Sep 11, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00009737 live on ClinicalTrials.gov.

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