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)
- Conditions
- locally advanced rectal carcinoma (cT3NxM0)
- Registration Number
- EUCTR2007-006750-26-AT
- Lead Sponsor
- Austrian Breast & Colorectal Cancer Study Group (ABCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 25
- 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
- life expectancy of at least 3 month
- INR and aPTT < 1.5 ULN
- signed Informed Consent before recruitment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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
- serious injuries, unhealed wounds or fractures
- patients with spinal compressons or metastases in central nervous system
- evidence of bleeding diathesis or coagulation dysfunction
- actual intake of anticoagulant or thrombolytic agents, Aspirin > 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+. If the dipstick protein is > +2 protein has to be measured in the urine of 24h. The maximum value of protein can be 1g/24h
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method