Back to resultsStudy Evaluating Isovorin in Colon Cancer
Primary Purpose
Colon Cancer
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Isovorin
UFT
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer focused on measuring Colon Cancer
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Relapse-free survival time
Secondary Outcome Measures
Disease-free survival time, survival time, safety
Full Information
NCT ID
NCT00195585
First Posted
September 12, 2005
Last Updated
August 12, 2009
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00195585
Brief Title
Study Evaluating Isovorin in Colon Cancer
Official Title
Post-Approved Phase III Study of 1-LV/5FU Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Colon Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
650 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Isovorin
Intervention Type
Drug
Intervention Name(s)
UFT
Primary Outcome Measure Information:
Title
Relapse-free survival time
Secondary Outcome Measure Information:
Title
Disease-free survival time, survival time, safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Isovorin in Colon Cancer
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