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NCT00195585 Clinical Trial

Study Evaluating Isovorin in Colon Cancer

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00195585
Other study ID # ISO/5FU-11
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated August 12, 2009
Start date October 2002
Est. completion date February 2006

Study information
Verified date August 2009
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 650
Est. completion date February 2006
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Isovorin

• UFT

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Relapse-free survival time
Secondary Disease-free survival time, survival time, safety
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