Randomized Study on Neoadjuvant Radio-Chemotherapy in Rectal Carcinoma Dukes B and C

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

A Prospectively Randomized Study on Neoadjuvant Radio-Chemotherapy in Patients With Operated Rectal Carcinoma Dukes B and C (pT2, pN1-3; pT3-4, pN0-3; M0.

This clinical investigation examined the influence of preoperative radiotherapy in combination with postoperative 5-fluorouracil + leucovorin chemotherapy vs. 5-fluorouracil + leucovorin + MAb 17-1A chemo-immunotherapy on patients' local recurrence rate and overall survival time following surgery for rectal carcinoma Dukes B or C (T2-4, N0-3, M0).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

700

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
      • Vienna, Austria, 1090
        • Medical University of Vienna, General Hospital
    • Burgenland
      • Oberpullendorf, Burgenland, Austria, 7350
        • Hospital Oberpullendorf
    • Lower Austria
      • Baden bei Wien, Lower Austria, Austria, 2500
        • Hospital Baden
      • Hainburg, Lower Austria, Austria, 2410
        • Hospital Hainburg
      • Wiener Neustadt, Lower Austria, Austria, 2700
        • Hospital Wiener Neustadt, Surgery
    • Styria
      • Graz, Styria, Austria, 8036
        • Medical University of Graz, Oncology
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • General Hospital Linz
      • Linz, Upper Austria, Austria, 4020
        • Hospital BHB Linz

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 rectal cancer Dukes B and C (Stage II, T2-4, N0-3, M0), R0
  • Age: 18-80 years
  • Karnofsky Performance Status > 80
  • Adequate bone marrow reserve (leukocytes > 4,000, thrombocytes > 105/mm3, Hb > 10g %), renal and hepatic functions (total bilirubin and creatinine < 1.25 x ULN)

Exclusion Criteria:

  • Colon cancer
  • R1, R2; carcinosis peritonei
  • Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
  • Previous application of a murine or chimeric monoclonal antibody or antibody fragment
  • Medical therapy with steroids, cyclosporin or antithymocyte globulin within 3 months pre-study
  • Known hypersensitivity to animal protein
  • Serious concomitant disease: HIV, chronically inflammatory intestine, diabetes mell. gravis, cerebral seizure disorder, et al.
  • Pregnancy or lactation

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 Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival
Local 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

July 1, 1997

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

October 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABSCG 92

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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