A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

September 15, 2003

Last Updated Date

October 15, 2009

Start Date ^ICMJE

April 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Superiority in disease-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Efficacy: Superiority in disease-free survival

Change History

Complete list of historical versions of study NCT00069121 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Efficacy: Overall survival Safety: Adverse events, laboratory tests

Descriptive Information

Brief Title ^ICMJE

A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer

Official Title ^ICMJE

A Randomized, Open-label Study of the Effect of Intermittent Xeloda in Combination With Eloxatin, Versus Fluorouracil/Leucovorin, on Disease-free Survival in Patients Who Have Undergone Surgery for Colon Cancer.2

Brief Summary

This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression 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: Oxaliplatin
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

Active, not recruiting

Estimated Enrollment ^ICMJE

1886

Estimated Completion Date

December 2011

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

adult patients >=18 years of age;
colon cancer;
complete tumor resection.

Exclusion Criteria:

prior treatment with cytotoxic chemotherapy, radiotherapy, or immunotherapy for the currently treated colon cancer.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Belgium, Brazil, Canada, China, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Republic of, Mexico, New Zealand, Panama, Poland, Portugal, Russian Federation, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00069121

Responsible Party

Disclosures Group, Hoffmann-La Roche

Study ID Numbers ^ICMJE

NO16968

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

October 2009

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