Study Evaluating Isovorin in Colon Cancer
August 12, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
Post-Approved Phase III Study of 1-LV/5FU Therapy
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.
Study Overview
Study Type
Interventional
Enrollment
650
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan, 104-0031
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Relapse-free survival time
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Secondary Outcome Measures
Outcome Measure |
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Disease-free survival time, survival time, safety
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2002
Primary Completion (ACTUAL)
February 1, 2006
Study Completion (ACTUAL)
February 1, 2006
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 15, 2005
First Posted (ESTIMATE)
September 19, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
August 13, 2009
Last Update Submitted That Met QC Criteria
August 12, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Colonic Neoplasms
- Physiological Effects of Drugs
- Protective Agents
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Leucovorin
- Levoleucovorin
Other Study ID Numbers
- ISO/5FU-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.