NCT01871363Unknown2 期
Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Pathological complete remission rate (pCR)
研究概览
简要总结
Pathological complete response, (pCR) correlates with a favourable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative IMRT combined with bevacizumab and capecitabine. primary endpoint is pathological complete remission rate.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with histologically proven adenocarcinoma of the rectum ,T3/4 or any node positive disease (clinical stage according the TNM classification system)
- •No evidence of metastatic disease.
- •Age 18 - 65 years
- •Kps 80-100
- •No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer
- •Normal hematological, hepatic and renal function, Ability to swallow tablets
- •Signed informed consent
- •Patients must be willing and able to comply with the protocol for duration of the study
排除标准
- •Malignancy of the rectum other than adenocarcinoma
- •Other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
- •Significant heart disease (uncontrolled hypertension despite of medication (> 150/100 mmHg), NYHA class III or IV heart disease,unstable angina or myocardial infarction within the past 1 year prior the study entry, history of significant ventricular arrhythmia requiring treatment)
- •Evidence of active peptic ulcer or upper GI bleeding
- •Evidence of bleeding diathesis or coagulopathy
- •Patients receiving a concomitant treatment with drugs interacting with capecitabine such as flucitosine, phenytoin, or warfarin
- •Known hypersensitivity to biological drugs
- •Treatment with any investigational drug within 30 days before beginning treatment with the study drug
- •Pregnant or lactating patient
结局指标
主要结局
Pathological complete remission rate (pCR)
时间窗: after pathological examination of surgical speciments (6-8 weeks after chemoradiation)
A TME surgery will be done 6-8 weeks after concurrent chemoradiation, pathological examination of surgical speciments will be show Pathological complete remission rate (pCR)
次要结局
- Acute and late toxicity(Toxicity/safety:during preoperative treatment, early and late postoperative follow up)
研究者
Hua Ren
Attending Radiation oncologist
Chinese Academy of Medical Sciences
研究点 (2)
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