Study Evaluating Isovorin in Colon Cancer

NCT ID: NCT00195585

Last Updated: 2009-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2006-02-28

Brief Summary

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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

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Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Isovorin

Intervention Type DRUG

UFT

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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ISO/5FU-11

Identifier Type: -

Identifier Source: org_study_id

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