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- 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
- Serious bone marrow suppression, infection, heart disease or complication
- Familial adenomatous polyposis or hereditary nonpolyposis
- Pregnant or breastfeeding women
Other exclusion applies
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Descriptive Information | ||||
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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 |
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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:
Other inclusion applies Exclusion Criteria:
Other exclusion applies | |||
Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
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 |
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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 |