Status:
COMPLETED
Preoperative Chemoradiation With Capecitabine and Cetuximab
Lead Sponsor:
Austrian Breast & Colorectal Cancer Study Group
Collaborating Sponsors:
Hoffmann-La Roche
Merck Gesellschaft mbH, Austria
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
* feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma * collection of respon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00297128
Start Date
October 1 2005
End Date
November 1 2011
Last Update
December 30 2011
Active Locations (10)
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1
Hospital BHB St. Veit/Glan, Surgery
Saint Veit A. D. Glan, Carinthia, Austria, 9330
2
Hospital Wiener Neustadt, Surgery
Wiener Neustadt, Lower Austria, Austria, 2700
3
Paracelsus Medical University Salzburg - Oncology
Salzburg, Salzburg, Austria, 5020
4
Medical University of Graz, Oncology
Graz, Styria, Austria, 8036