Preoperative Chemoradiation With Capecitabine and Cetuximab

December 29, 2011 updated by: Austrian Breast & Colorectal Cancer Study Group

Preoperative Chemoradiation With Capecitabine and Cetuximab Within a Multidisciplinary Therapeutic Approach in Patients With Operable T3-T4 Rectal Cancer: a Phase II Study

  • feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma
  • collection of response rate (T-downstaging, pathological complete remission), correlation of responsiveness with EGFR-status

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

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 of Vienna, Radiotherapy
    • Carinthia
      • St. Veit a. d. Glan, Carinthia, Austria, 9330
        • Hospital BHB St. Veit/Glan, Surgery
    • Lower Austria
      • 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
      • Innsbruck, Tyrol, Austria, 6020
        • Medical University of Innsbruck, Surgery
    • Upper Austria
      • Linz, Upper Austria, Austria, 4010
        • Hospital BHS Linz, Radiooncology
      • Wels, Upper Austria, Austria, 4600
        • Klinikum Wels-Grieskirchen
    • 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:

  • Age: 18-80
  • bioptical confirmed adenocarcinoma of the rectum in operable T3-T4NxM0 status. In spite of infiltration of the neighbouring organs the tumor has to be basically surgically complete resectable
  • no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of a rectum carcinoma
  • WHO performance status 0-2
  • adequate bone marrow reserve (granulocytes - not more than 1.500/µl; thrombocytes - not more than 100.000/µl)
  • adequate hepatic function ( bilirubin - not more than 1.5 x ULN; GOT and GPT - not more than 3.5 x ULN)
  • adequate renal function (creatinin - not more than 1.5 mg/dl)
  • women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test)
  • willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (e.g. birth-control pill, loop, condom) during and at least 3 month after conclusion of the study
  • life expectancy of at least 3 month
  • signed Informed Consent before recruitment
  • exclusion of distant metastases at the time of recruitment

Exclusion Criteria:

  • former radiotherapy of pelvis or abdomen
  • former chemotherapy
  • any other kind of malign tumor (except adequate treated skin basalioma or in situ cervical carcinoma) in the last 5 years
  • general contraindication or known hypersensitivity against Cetuximab and/or Capecitabine
  • Non malign disease, if there is a contraindication with radiotherapy or chemotherapy with Cetuximab and Capecitabine or a resection of the rectum: high-graded cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic disease, significant neurological or psychiatric disorders
  • florid, serious infections at the time of recruitment
  • legally limited contractual capability or evidence of neurological or psychiatric disease, if it will constrict the patients compliance in the opinion of the investigator
  • evidence of lacking cooperation of the patient
  • pregnant or breast feeding women

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Drug: Capecitabine
825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
Other Names:
  • Xeloda
Drug: Cetuximab
400mg/m2 week 1, 250mg/m2 week 2-4
Other Names:
  • Erbitux

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma
Time Frame: descriptive evaluation
descriptive evaluation

Secondary Outcome Measures

Outcome Measure
Time Frame
collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status
Time Frame: description evaluation
description evaluation

Collaborators and Investigators

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

Sponsor

Austrian Breast & Colorectal Cancer Study Group

Collaborators

Hoffmann-La Roche
Merck Gesellschaft mbH, Austria

Investigators

  • Principal Investigator: Josef Thaler, MD, Austrian Breast & Colorectal Cancer Study Group
  • Principal Investigator: Joerg Tschmelitsch, MD, 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, 2005

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

February 27, 2006

First Submitted That Met QC Criteria

February 27, 2006

First Posted (Estimate)

February 28, 2006

Study Record Updates

Last Update Posted (Estimate)

December 30, 2011

Last Update Submitted That Met QC Criteria

December 29, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABCSG R03 (96) / TAKO 06

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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