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OpenTrials
Completed

NCT Number: NCT00195585

Study Evaluating Isovorin in Colon Cancer

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tokyo, 104-0031, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isovorin

Drug

UFT

Drug

Primary outcomes

  1. Relapse-free survival time

Secondary outcomes

  1. Disease-free survival time, survival time, safety

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Aug 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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