Preoperative combined RadioChemo-MolecularTargetedTherapie (RC-MTTx) of the locally advanced rectal carcinoma (cT3NxM0) – a phase II pilot study with preoperative application of capecitabine (Xeloda), bevacizumab (Avastin) and radiotherapy (RTx)

Austrian Breast & Colorectal Cancer Study Group (ABCSG)0 sites25 target enrollmentJanuary 2, 2008

Overview

No summary available.

Registry

who.int

Start Date

January 2, 2008

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Austrian Breast & Colorectal Cancer Study Group (ABCSG)

•\- age: 18 – 80
•\- bioptical confirmed adenocarcinoma of the rektum in T3NxM0 status. The tumor has to be basically surgically complete resectable (\-\>R0\).
•\- no former chemotherapy, no radiotherapy of pelvis or abdomen and/or tumor resection of rectum carcinoma
•\- WHO performance status 0\-2
•\- adequatic bone marrow reserve (granulocytes \> 3\.000/µl, absolute rate of neutrophile \> 1,5x109/l, thrombocytes: \> 100\.000/µl, haemoglobin \> 10 g/l)
•\- adequate hepatic function (Bilirubin: \< 1\.5 x ULN, GOT und GPT \< 2\.5 x ULN)
•\- adequate renal function (creatinin: \< 1\.25 mg/dl, Kreatinin\-Clearance: \> 50 ml/min (Cockroft and Gault Formel), proteinuria: dipstick \< 2\+. In case of dipstick \> 2\+ protein has to be meassured in 24h urine and does not exceed more than 1g /24h)
•\- ability of intake of pills
•\- women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test)
•\- willigness 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

•\- former radiothrapy of pelvis or abdomen
•\- former chemotherapy
•\- any other kind of malign tumor in the last 5 years
•\- any other kind of tumour in the last 5 years with exceptence of basal cell carcinoma of skin and cervixcarcinoma in situ
•\- general contraindiction or known hypersensitivity against Bevacizumab and/or Capecitabine
•\- non malign disease, if there is a contraindiction with radiotherapy, or chemotherapy with Bevacizumab and Capecitabine, or a resection of rectum: uncontrolled hypertension (systolic \> 150 mmHG and/or diastolic \>100 mmHG) or clinical significant (e.g. active) cardiovascular disease: CVA (kardiovascular accident)/ cerbral apoplexia (\< 6 moths before recruitment), myocardial infarct (\< 6 months before recruitment), instabil angina pectoris, CHF with NYHA status II or higher, or treated serious arrhythmia, hepatic disease, significant neurologic 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
•\- major intervention within 28 days before recruitment, open wounds