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Fluorouracil, Semustine, and Vincristine Compared With BCG in Treating Patients With Dukes' B or Dukes' C Colon Cancer That Has Been Removed By Surgery

NCT00427570 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2013-06-24

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as vincristine, fluorouracil, and semustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as BCG, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether combination chemotherapy is more effective than BCG in treating colon cancer that has been removed by surgery.

PURPOSE: This randomized phase III clinical trial is studying giving fluorouracil together with semustine and vincristine to see how well they work compared with giving BCG in treating patients with Dukes' B or Dukes' C colon cancer that has been removed by surgery.

Conditions

Interventions

BIOLOGICAL

BCG vaccine

BIOLOGICAL

biological therapy

DRUG

fluorouracil

DRUG

semustine

DRUG

vincristine sulfate

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NSABP Foundation Inc

    lead NETWORK

Principal Investigators

  • Norman Wolmark, MD · Allegheny Cancer Center at Allegheny General Hospital

Study Design

Purpose
TREATMENT

Eligibility

Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1977-09-30
Completion
2006-05-31

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Entities

Drugs
Diseases

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 NCT00427570 on ClinicalTrials.gov