Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

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

A Prospectively Randomized Study on Adjuvant Chemotherapy in Patients With Operated Colon Carcinoma Dukes B (Stage II; T3-4, N0, M0).

This clinical investigation examined the influence of cytostatic chemotherapy with 5-fluorouracil, modulated by biologically active leucovorin, on patients' survival time following surgery for colon carcinoma Stage II.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

636

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
    • Lower Austria
      • Hainburg, Lower Austria, Austria, 2410
        • Hospital Hainburg
      • Krems, Lower Austria, Austria, 3500
        • Hospital Krems
      • Tulln, Lower Austria, Austria, 3430
        • Hospital Tulln
      • Waidhofen a. d. Thaya, Lower Austria, Austria, 3830
        • Hospital Waidhofen/Thaya
      • Wiener Neustadt, Lower Austria, Austria, 2700
        • Hospital Wiener Neustadt, Surgery
    • Styria
      • Graz, Styria, Austria, 8036
        • Medical University of Graz, Oncology
      • Leoben, Styria, Austria, 8700
        • State Hospital Leoben
    • Tyrol
      • Zams, Tyrol, Austria, 6511
        • Hospital St. Vinzenz
    • Upper Austria
      • Kirchdorf, Upper Austria, Austria, 4560
        • State Hospital Kirchdorf
      • 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, operable colon carcinoma Stage II (RO, T3-4, N0, M0)
  • Age: less than 80 years
  • WHO Performance > 2
  • Adequate bone marrow reserve, renal and hepatic functions
  • Informed consent

Exclusion Criteria:

  • Rectal cancer
  • R1or R2 resection; carcinosis peritonei
  • Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
  • Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic or metabolic 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: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall 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

November 1, 1993

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

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABCSG 91

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.

Subscribe