A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
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.
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
- Enrollment
- 1,987 participants
Conditions and interventions
Conditions
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
- Nov 1998 (Type not available)
- Primary completion
- Apr 2004 (Actual)
- Completion
- Apr 2004 (Actual)
- Last update posted
- Jun 22, 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 22, 2016 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00009737 live on ClinicalTrials.gov.