Genetic Profile on Predicting Sensibility of Preoperative Chemoradiotherapy on Locally Advanced Rectal Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- gene expression in different response groups
研究概览
简要总结
The aim of this study is to find some genetic factors in predicting the sensibility of preoperative chemoradiotherapy for locally advanced rectal carcinoma.
详细描述
For locally advanced rectal carcinoma,preoperative chemoradiotherapy(CRT) achieved similar overall survival and better local control compared with postoperative therapy,so it was considered to be one of the standard therapy of these patients.But,not every one will be cured,the possible reason is the difference gene expression and mutation status among patients.So,we performed this trial to study the relationship between genetic factors and response of preoperative CRT for locally advanced rectal cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed rectal adenocarcinoma, preoperative stage II / III (T3-4N0 or T1-4N + M0).
- •Distance from the lower bound of tumor to the anal verge is less than 12 cm.
- •KPS score not less than 70
- •Can be tolerated chemotherapy and radiotherapy.
- •No history of radiation therapy to the pelvis.
- •Non-allergic history of fluorouracil or platinum-based chemotherapy drugs.
- •Full understanding of the study, the ability to complete all of the treatment plan, follow up the conditions and sign the informed consent. -
排除标准
- •Other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous).
- •Pregnant or lactating patients.
- •Fertility but did not use contraceptive measures.
- •Existing active infection.
- •Merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension.
- •Concurrent treatment with other anticancer drugs.
- •Can not complete treatment or follow-up
结局指标
主要结局
gene expression in different response groups
时间窗: 6 months after radical surgery
次要结局
- overall survival, disease free survival and local-regional free survival(3 years after pre-operative chemoradiotherapy)
研究者
Jing Jin, M.D.
Vice Director of Abdomen Division, Radiation Oncology Department
Chinese Academy of Medical Sciences