Preoperative Chemoradiation With Capecitabine and Cetuximab
NCT ID: NCT00297128
Last Updated: 2011-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2005-10-31
2011-11-30
Brief Summary
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* collection of response rate (T-downstaging, pathological complete remission), correlation of responsiveness with EGFR-status
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Capecitabine
825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
Cetuximab
400mg/m2 week 1, 250mg/m2 week 2-4
Interventions
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Capecitabine
825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
Cetuximab
400mg/m2 week 1, 250mg/m2 week 2-4
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Merck Gesellschaft mbH, Austria
INDUSTRY
Austrian Breast & Colorectal Cancer Study Group
NETWORK
Responsible Party
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Principal Investigators
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Josef Thaler, MD
Role: PRINCIPAL_INVESTIGATOR
Austrian Breast & Colorectal Cancer Study Group
Joerg Tschmelitsch, MD
Role: PRINCIPAL_INVESTIGATOR
Austrian Breast & Colorectal Cancer Study Group
Alexander de Vries, MD
Role: PRINCIPAL_INVESTIGATOR
Austrian Breast & Colorectal Cancer Study Group
Locations
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Hospital BHB St. Veit/Glan, Surgery
Saint Veit A. D. Glan, Carinthia, Austria
Hospital Wiener Neustadt, Surgery
Wiener Neustadt, Lower Austria, Austria
Paracelsus Medical University Salzburg - Oncology
Salzburg, Salzburg, Austria
Medical University of Graz, Oncology
Graz, Styria, Austria
State Hospital Leoben
Leoben, Styria, Austria
Medical University of Innsbruck, Surgery
Innsbruck, Tyrol, Austria
Hospital BHS Linz, Radiooncology
Linz, Upper Austria, Austria
Klinikum Wels-Grieskirchen
Wels, Upper Austria, Austria
Medical University of Vienna, Radiotherapy
Vienna, Vienna, Austria
State Hospital Feldkirch
Feldkirch, Vorarlberg, Austria
Countries
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Related Links
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Related Info
Other Identifiers
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ABCSG R03 (96) / TAKO 06
Identifier Type: -
Identifier Source: org_study_id