Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During During Neoadjuvant Chemoradiation With Capecitabine and Irinotecan
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Adverse Events
研究概览
简要总结
This project first retrospectively analyzes the intestinal dose indicators related to the concurrent radiotherapy and chemotherapy of rectal cancer and gastrointestinal toxicity, and the pelvic dose indicators related to hematological toxicity, and then prospectively conducts radiotherapy based on the dose indicators most closely related to toxicity. The dose is limited when the plan is made to reduce the gastrointestinal and hematological toxicity of rectal cancer with concurrent radiotherapy and chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients with rectal adenocarcinoma
- •Clinical staged T3/4 or any node-positive disease
- •Age of 18-75 years
- •Karnofsky Performance Status > 80
- •Adequate bone marrow reserve, renal and hepatic functions
- •Without previous antitumoural chemotherapy
- •No evidence of metastatic disease
- •Written informed consent before randomization
- •UGT1A1's genotype of 6/6 or 6/7
排除标准
- •Clinical staged I or IV
- •Age of <18 or >75 years
- •Karnofsky Performance Status < 80
- •Previous pelvis radiotherapy
- •Previous antitumoural chemotherapy
- •Clinically significant internal disease
- •Refuse to write informed consent before randomization
- •UGT1A1's genotype of 7/7
研究组 & 干预措施
experimental arm
peritoneal space V15<850cc，pelvic bone V10<80% and normal dosimetric limitation
干预措施: dosimetric limitation of pelvic bone and peritoneal space during radiotherapy (Radiation)
control arm
normal dosimetric limitation
结局指标
主要结局
Number of Participants Experiencing Adverse Events
时间窗: up to 3 years
次要结局
- Number of Participants in Who Experienced Tumor Down-staging(up to 3 years)