Study Evaluating Isovorin in Colon Cancer

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00195585

Enrollment

650

Registered

2005-09-19

Start date

2002-10-31

Completion date

2006-02-28

Last updated

2009-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

Colon Cancer

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.

Interventions

DRUGIsovorin

DRUGUFT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Relapse-free survival time	—

Secondary

Measure	Time frame
Disease-free survival time, survival time, safety	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026