Study of Safety and Feasibility of the Intersphincteric Resection With or Without Intraoperative Radiation in Low Rectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 3-year disease free survival
研究概览
简要总结
The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.
详细描述
Inter-sphincteric resection (ISR) has become an increasingly popular optional surgical tool for the treatment of very low rectal cancer. Nowadays, preoperative criteria for Lap ISR were the patients whose diagnosed with clinical stages T1-2 and N0_1, which only a few patients with early stages can benefit from it. However, intra-operative radiotherapy with low energy X ray applied by Intrabeam is becoming an accepted radiotherapy technique for treatment of cancers. The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Patients will be assigned to two different groups and receive intraoperative radiation randomly. The care provider and investigator also don't know the concrete situation of the patients.
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
- •those whom were preoperatively assessed to be in clinical stageT3 or has lymphatic metastasis by MRI or ultrasonic endoscopy;
- •the lower edge of the tumor is away from the anal edge by less than 5 cm, or away from the dentate line by less than 3cm;
- •in intra-operative separation, the lower edge of the tumor is below the plane of the levator ani muscle or the tumor is hard to separate;
- •those in T4 stage and could be radically resected by intra-operative surgeon assessment;
- •adequate preoperative sphincter function and continence; (vi)local spread restricted to the rectal wall or the IAS.
- •absence of distant metastases.
排除标准
- •clinical T4 tumors based on the Union for International Cancer Control UICC TNM classification (7th edition):
- •infiltrating gross appearance of the tumors;
- •poorly differentiated adenocarcinoma by biopsy specimens;
- •a degree of preoperative incontinence.
研究组 & 干预措施
A group
Patients who receive interphincteric resection (ISR) in this group will be given extra intraoperative radiation by INTRBEAM using low energy X-ray.
干预措施: Interoperative radiation by INTRABEAM using low energy X-ray (Radiation)
B group
Patients who only receive interphincteric resection (ISR) in this group without intraoperative radiation.
结局指标
主要结局
3-year disease free survival
时间窗: 3 years
Compare 3-year disease free survival in patients with resectable rectal cancer treated with or without radiation.
次要结局
- R0 resection rate(1 years)
- sphincter muscle function(1 years)
- local recurrence rate(1 years)
- anorectal manometry(1 years)
- predictive biomarkers(3 years)
- sexual function(1 years)