Trial record 1 of 1 for: NCT00195585

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Study Evaluating Isovorin in Colon Cancer

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ClinicalTrials.gov Identifier: NCT00195585

Recruitment Status : Completed

First Posted : September 19, 2005

Last Update Posted : August 13, 2009

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

First Submitted Date ^ICMJE

September 12, 2005

First Posted Date ^ICMJE

September 19, 2005

Last Update Posted Date

August 13, 2009

Study Start Date ^ICMJE

October 2002

Actual Primary Completion Date

February 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Relapse-free survival time

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Disease-free survival time, survival time, safety

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study Evaluating Isovorin in Colon Cancer

Official Title ^ICMJE

Post-Approved Phase III Study of 1-LV/5FU Therapy

Brief Summary

The purpose of the study is to verify superiority of 1-LV/5FU therapy to UFT Therapy of relapse-free survival time in patients with Dukes C and Cure A colon cancer. Secondary endpoints include disease-free survival time, survival time, and safety.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Colon Cancer

Intervention ^ICMJE

Drug: Isovorin
Drug: UFT

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

650

Original Enrollment ^ICMJE

Same as current

Actual Study Completion Date ^ICMJE

February 2006

Actual Primary Completion Date

February 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Dukes C, Cure A colon cancer diagnosed histologically or cytologically
Normal organ function of bone marrow, heart, liver and kidney
Age 20-75

Other inclusion applies

Exclusion Criteria:

Serious bone marrow suppression, infection, heart disease or complication
Familial adenomatous polyposis or hereditary nonpolyposis
Pregnant or breastfeeding women

Other exclusion applies

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

20 Years to 75 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Japan

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00195585

Other Study ID Numbers ^ICMJE

ISO/5FU-11

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

PRS Account

Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

August 2009

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

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