Phase II Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and adverse events of intensity modulated radiation therapy (IMRT) concurrent with chemotherapy for anal squamous carcinoma. All enrolled anal squamous carcinoma patients are intented to receive IMRT concurrent with Capecitabine + mitomycin ± cetuximab targeted therapy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CT/MRI diagnosed stage cT1-4N0-3;
- •Histologically confirmed anal squamous carcinoma;
- •KPS >= 70
- •Adequate organ function;
- •No previous radiotherapy or chemotherapy;
- •No surgery.
排除标准
- •Previous malignant cancer history;
- •Allegic to 5-fu or MMC
研究组 & 干预措施
Chemo-radiotherapy with IMRT technique
Radiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy
干预措施: Chemo-radiotherapy with IMRT technique (Radiation)
Chemo-radiotherapy with IMRT technique
Radiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy
干预措施: Capecitabine (Drug)
Chemo-radiotherapy with IMRT technique
Radiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy
干预措施: Mitomycin C (Drug)
结局指标
主要结局
Response rate
时间窗: 8 weeks after IMRT
To evaluate response rate of IMRT with chemotherapy
次要结局
- Adverse events(from start of IMRT to 8 weeks after IMRT)
研究者
LI Ning
Principal Investigator
Chinese Academy of Medical Sciences