locally advanced rectal carcinoma (cT3NxM0)
Conditions
Sponsors
Austrian Breast & Colorectal Cancer Study Group (ABCSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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: 50 ml/min (Cockroft and Gault Formel), proteinuria: 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 - life expectancy of at least 3 month - INR and aPTT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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 ( 325 mg/d or within 10 days before study start) - actual or recent (within 10 days before recruitment) therapeutic therapy with fully-dosed anticoagulants. A prophylactic treatment is permitted. - previous thromboembolic or hemorraghic events within the last 6 months before recruitment - previous abdominal fistulas, GI perfoation or intra-abdominal abscess within the last 6 months - treatment with other study medication within 28 days before recruitment - patients with malabsorption syndrome or difficulties swallowing - pregnant or breast feeding women - proteinuria: dipstick +2 protein has to be measured in the urine of 24h. The maximum value of protein can be 1g/24h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: feasibility and tolerance of preoperative therapy with Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally operable rectal carcinoma;Secondary Objective: collection of response rate (T- and M-downstaging, pathological complete remission);Primary end point(s): feasibility and tolerance of preoperative therapy with bevacizumab (Avastin) in combination with capecitabine (Xeloda) and radiotherapy for patients with locally advanced rectal carcinoma | — |
Countries
Austria
Outcome results
None listed