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

Tracking Information

First Received Date ^ICMJE

February 2, 2001

Last Updated Date

May 13, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Non-inferiority in disease-free survival, overall survival, and relapse-free survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Non-inferiority in disease-free survival, overall survival and relapse-free survival

Change History

Complete list of historical versions of study NCT00009737 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

AEs, laboratory parameters, QoL. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Safety: Adverse events and laboratory measurements.
Quality of life. Medical care required.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Open-Label Study Comparing Adjuvant Chemotherapy With Xeloda, or 5-Fluorouracil Plus Leucovorin, on Disease-Free and Overall Survival in Patients Who Have Had Surgery for Colon Cancer

Brief 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-FU 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Colorectal Cancer

Intervention ^ICMJE

Drug: capecitabine [Xeloda]
Drug: Leucovorin
Drug: 5-FU

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

3348

Completion Date

March 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

previous chemotherapy

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00009737

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Study ID Numbers ^ICMJE

M66001

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP