Randomized Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Colon Carcinoma Dukes C

March 31, 2006 updated by: Austrian Breast & Colorectal Cancer Study Group

A Prospectively Randomized Phase III Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Patients With Operated Colon Carcinoma Dukes C (Stage III; T1-4, N1-30, M0).

This clinical investigation examined the effectivity 5-fluorouracil, of adding levamisol or interferon to 5-fluorouracil, and of a 5-fluorouracil/levamisol/interferon triple combination, in terms of recurrence-free and overall survival in curatively operable colon carcinoma Stage III.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

598

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Paracelsus Medical University Salzburg - Oncology
      • Vienna, Austria, 1090
        • Medical University Vienna, General Hospital
      • Vienna, Austria, 1160
        • Wilheminenspital, Internal Medicin I
    • Burgenland
      • Guessing, Burgenland, Austria, 7540
        • Hospital Guessing
      • Oberpullendorf, Burgenland, Austria, 7350
        • Hospital Oberpullendorf
    • Carinthia
      • St. Veit a. d. Glan, Carinthia, Austria, 9330
        • Hospital BHB St. Veit/Glan, Surgery
      • Wolfsberg, Carinthia, Austria, 9400
        • State Hospital Wolfsberg
    • Styria
      • Graz, Styria, Austria, 8036
        • Medical University of Graz, Oncology
      • Leoben, Styria, Austria, 8700
        • State Hospital Leoben, Surgery
    • Tyrol
      • Zams, Tyrol, Austria, 6511
        • Hospital St. Vinzenz
    • Upper Austria
      • Kirchdorf, Upper Austria, Austria, 4560
        • State Hospital Kirchdorf
      • Linz, Upper Austria, Austria, 4020
        • General Hospital Linz
      • Linz, Upper Austria, Austria, 4020
        • Hospital BHB Linz
      • Voecklabruck, Upper Austria, Austria, 4840
        • State Hospital Voecklabruck, Internal Medicine
      • Wels, Upper Austria, Austria, 4600
        • Hospital Kreuzschwestern Wels
    • Vorarlberg
      • Feldkirch, Vorarlberg, Austria, 6807
        • State Hospital Feldkirch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with histologically verified, curatively operated colon carcinoma Stage III (R0, T1-4, N1-3, M0)
  • Age: less than 80 years
  • WHO Performace Status > 2
  • Adequate bone marrow reserve
  • Informed consent

Exclusion Criteria:

  • Rectal cancer
  • R1, R2, carcinosis peritonei
  • Start of chemo- or chemo-immunotherapy > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
  • Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic disease, malignant second carcinoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival
Recurrence-free survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Austrian Breast & Colorectal Cancer Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1990

Study Registration Dates

First Submitted

March 31, 2006

First Submitted That Met QC Criteria

March 31, 2006

First Posted (Estimate)

April 3, 2006

Study Record Updates

Last Update Posted (Estimate)

April 3, 2006

Last Update Submitted That Met QC Criteria

March 31, 2006

Last Verified

April 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABCSG 90

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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