NCT00297128已完成2 期
Preoperative Chemoradiation With Capecitabine and Cetuximab Within a Multidisciplinary Therapeutic Approach in Patients With Operable T3-T4 Rectal Cancer: a Phase II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 10
- 主要终点
- feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma
研究概览
简要总结
- feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma
- collection of response rate (T-downstaging, pathological complete remission), correlation of responsiveness with EGFR-status
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 operable T3-T4NxM0 status. In spite of infiltration of the neighbouring organs the tumor has to be basically surgically complete resectable
- •no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of a rectum carcinoma
- •WHO performance status 0-2
- •adequate bone marrow reserve (granulocytes - not more than 1.500/µl; thrombocytes - not more than 100.000/µl)
- •adequate hepatic function ( bilirubin - not more than 1.5 x ULN; GOT and GPT - not more than 3.5 x ULN)
- •adequate renal function (creatinin - not more than 1.5 mg/dl)
- •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
- •signed Informed Consent before recruitment
- •exclusion of distant metastases at the time of recruitment
排除标准
- •former radiotherapy of pelvis or abdomen
- •former chemotherapy
- •any other kind of malign tumor (except adequate treated skin basalioma or in situ cervical carcinoma) in the last 5 years
- •general contraindication or known hypersensitivity against Cetuximab and/or Capecitabine
- •Non malign disease, if there is a contraindication with radiotherapy or chemotherapy with Cetuximab and Capecitabine or a resection of the rectum: high-graded cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic disease, significant neurological 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
- •pregnant or breast feeding women
研究组 & 干预措施
1
Active Comparator
干预措施: Capecitabine (Drug)
1
Active Comparator
干预措施: Cetuximab (Drug)
结局指标
主要结局
feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma
时间窗: descriptive evaluation
次要结局
- collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status(description evaluation)
研究者
研究点 (10)
Loading locations...
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