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Study Evaluating Isovorin in Colon Cancer

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: September 12, 2005
Last updated: August 12, 2009
Last verified: August 2009
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.

Condition Intervention Phase
Colon Cancer
Drug: Isovorin
Drug: UFT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-Approved Phase III Study of 1-LV/5FU Therapy

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Relapse-free survival time

Secondary Outcome Measures:
  • Disease-free survival time, survival time, safety

Estimated Enrollment: 650
Study Start Date: October 2002
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00195585

Tokyo, Japan, 104-0031
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information Identifier: NCT00195585     History of Changes
Other Study ID Numbers: ISO/5FU-11
Study First Received: September 12, 2005
Last Updated: August 12, 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Colon Cancer

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Protective Agents
Physiological Effects of Drugs processed this record on May 22, 2017