NCT00671645终止2 期
Preoperative Combined RadioChemo-MolecularTargetTherapy of the Locally Advanced Rectum Carcinoma (cT3NxM0) - a Phase II Pilot Study With Preoperative Application of Capecitabine, Bevacizumab and Radiotherapy (RTx)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 10
- 主要终点
- feasibility and tolerance of preoperative therapy with Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally operable rectal carcinoma
研究概览
简要总结
- feasibility and tolerance of preoperative therapy with Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally operable rectal carcinoma
- collection of response rate (T- and M-downstaging, pathological complete remission)
详细描述
Combined RadioChemotherapy:
Therapy start: within 28 days after bioptical diagnosis
Radiotherapy: 5 x 5 days 1.8 Gy radiotherapy; cummulative dose 45 Gy
Chemotherapy: Capecitabin 825mg/m² bid, on each radiation day during the first 4 weeks RCTx
Molecular Targeted Therapy: Bevacizumab 5 mg/kg body weight; day 1, 15, 29 Operation due to TME adherence to a break of min. 42 to max. 56 days after the last application of bevacizumab
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 18 - 80
- •bioptical confirmed adenocarcinoma of the rectum in T3NxM0 status. The tumor has to be basically surgically complete resectable (->R0).
- •no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of rectum carcinoma
- •WHO performance status 0-2
- •adequate bone marrow reserve (granulocytes >= 3.000/µl, absolute neutrophil >= 0 1,5 x 10 9/l thrombocytes: >= 100.000/µl, haemoglobin >= 10g/dl)
- •adequate hepatic function (Bilirubin: <= 1.5 x ULN, GOT und GPT <= 2.5 x ULN)
- •adequate renal function (creatinin: <= 1.25 mg/dl, creatinin-clearance: > 50 ml/min (Cockcroft and Gault formula)), proteinuria: dipstick < 2+. In case of dipstick > 2+ protein has to be measured 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)
- •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
- •INR and aPTT < 1.5 ULN
- •signed Informed Consent before recruitment
排除标准
- •failure of one inclusion criteria
- •former radiotherapy 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 exception of basal cell carcinoma of skin and cervix carcinoma in situ
- •general contraindication or known hypersensitivity against Bevacizumab and/or Capecitabine
- •non malign disease, if there is a contraindication 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 (cardiovascular accident)/ cerebral apoplexy (< 6 months before recruitment), myocardial infarct (< 6 months before recruitment), instable 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
- •peripheral neuropathy (NCI CTC >= Grade 1)
- •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 compressions 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 hemorrhagic events within the last 6 months before recruitment
- •previous abdominal fistulas, GI perforation 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
研究组 & 干预措施
1
Experimental
干预措施: capecitabine, bevacizumab (Drug)
结局指标
主要结局
feasibility and tolerance of preoperative therapy with Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally operable rectal carcinoma
时间窗: descriptive evaluation
次要结局
- collection of response rate (T- and M-downstaging, pathological complete remission)(descriptive evaluation)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
2 期
Preoperative Chemoradiation With Capecitabine and CetuximabRectal CancerNCT00297128Austrian Breast & Colorectal Cancer Study Group31
Unknown
2 期
Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical CancerLocally Advanced Cervical CancerNCT01938105People's Hospital of Guangxi40
已完成
2 期
Bevacizumab, Radiation Therapy, and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Nonmetastatic Rectal CancerRectal AdenocarcinomaStage II Rectal Cancer AJCC v7Stage III Rectal Cancer AJCC v7NCT00321685National Cancer Institute (NCI)57
终止
2 期
Combination Chemotherapy and Bevacizumab Before Surgery and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal CancerLiver MetastasesRecurrent Colon CancerRecurrent Rectal CancerStage IVA Colon CancerStage IVA Rectal CancerStage IVB Colon CancerStage IVB Rectal CancerNCT01320683City of Hope Medical Center1
已完成
2 期
Preoperative Combined Induction Chemotherapy With Capecitabine, Oxaliplatin, Bevacizumab and RadiotherapyRectal CancerNCT01434147Austrian Breast & Colorectal Cancer Study Group25