Randomized Phase III Adjuvant Study for Stage III Colorectal Cancer

NCT00209742 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2010-05-26

No results posted yet for this study

Summary

A randomized controlled study is conducted on patients with histological stage III colorectal cancer assigned to postoperative adjuvant therapy of uracil-tegafur plus leucovorin (UFT+LV), UFT+LV / UFT, or UFT+LV+PSK / UFT+PSK. The usefulness of the three regimens was evaluated by comparing the disease-free survival rate, overall survival rate, incidence and severity of adverse event, and quality of life.

Conditions

Interventions

DRUG

UFT

P.O. everyday

DRUG

USEL/Leucovorin

P.O. everyday

DRUG

Krestin

P.O. everyday

Sponsors & Collaborators

  • Hokkaido University Hospital

    collaborator OTHER
  • Hokkaido Gastrointestinal Cancer Study Group

    lead OTHER

Principal Investigators

  • Masahiro Asaka, MD, PhD · Hokkaido Gastrointestinal Cancer Study Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Japan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00209742 on ClinicalTrials.gov