EUCTR2007-006750-26-AT进行中（未招募）1 期
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 个研究点目标入组 25 人开始时间: 2008年1月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
排除标准
- •- 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
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