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Preoperative Chemoradiation With Capecitabine and Cetuximab

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00297128
First Posted: February 28, 2006
Last Update Posted: December 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hoffmann-La Roche
Merck Gesellschaft mbH, Austria
Information provided by (Responsible Party):
Austrian Breast & Colorectal Cancer Study Group
  Purpose
  • 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

Condition Intervention Phase
Rectal Cancer Drug: Capecitabine Drug: Cetuximab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Chemoradiation With Capecitabine and Cetuximab Within a Multidisciplinary Therapeutic Approach in Patients With Operable T3-T4 Rectal Cancer: a Phase II Study

Resource links provided by NLM:


Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status [ Time Frame: description evaluation ]

Enrollment: 31
Study Start Date: October 2005
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Capecitabine
825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
Other Name: Xeloda
Drug: Cetuximab
400mg/m2 week 1, 250mg/m2 week 2-4
Other Name: Erbitux

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00297128


Locations
Austria
Hospital BHB St. Veit/Glan, Surgery
St. Veit a. d. Glan, Carinthia, Austria, 9330
Hospital Wiener Neustadt, Surgery
Wiener Neustadt, Lower Austria, Austria, 2700
Medical University of Graz, Oncology
Graz, Styria, Austria, 8036
State Hospital Leoben
Leoben, Styria, Austria, 8700
Medical University of Innsbruck, Surgery
Innsbruck, Tyrol, Austria, 6020
Hospital BHS Linz, Radiooncology
Linz, Upper Austria, Austria, 4010
Klinikum Wels-Grieskirchen
Wels, Upper Austria, Austria, 4600
State Hospital Feldkirch
Feldkirch, Vorarlberg, Austria, 6807
Paracelsus Medical University Salzburg - Oncology
Salzburg, Austria, 5020
Medical University of Vienna, Radiotherapy
Vienna, Austria, 1090
Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
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
Principal Investigator: Alexander de Vries, MD Austrian Breast & Colorectal Cancer Study Group
  More Information

Additional Information:
Responsible Party: Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier: NCT00297128     History of Changes
Other Study ID Numbers: ABCSG R03 (96) / TAKO 06
First Submitted: February 27, 2006
First Posted: February 28, 2006
Last Update Posted: December 30, 2011
Last Verified: December 2011

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
pilot study
rectal
cancer
phase II
preoperative
chemoradiation
capecitabine
cetuximab
operable
T4
ABCSG
TAKO
R03
96
06

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents