Surgery Without Neoadjuvant Chemoradiotherapy Compared With Neoadjuvant Chemoradiotherapy for Rectal Cancer With Negative Circumferential Resection Margin Based on MRI Assessment, a Perspective Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- circumferential resection margin
研究概览
简要总结
For now, neoadjuvant chemoradiotherapy is routinely performed for T3N1-2M0 rectal cancer. However, there are lots of complications following neoadjuvant chemoradiotherapy, such as Wound-related complications, anastomotic leakage, anastomotic stenosis, sexual dysfunction, testicular or ovary failure. Patients undergoing resection for rectal cancer had low rates of local recurrence and long disease-free survival regardless of whether an APR, CAA or low AR was performed. The main purpose of preoperative radiotherapy is to lower the local recurrence. For the T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, we suppose might not necessary to receive neoadjuvant chemoradiotherapy, for operation can achieve the negative circumferential resection margin.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tumor within 12 cm of the anal verge
- •T3N1-2 as determined by preoperative MRI examination
- •negative circumferential resection margin determined by preoperative MRI examination
- •Absence of distant metastases
- •Absence of intestinal obstruction
排除标准
- •With distant metastases
- •With intestinal obstruction
- •Pregnancy or lactation
- •With operation contraindication
- •With mental disorder
结局指标
主要结局
circumferential resection margin
时间窗: one week after operation
introperative perforation
时间窗: During the operation
次要结局
- local recurrece(3 years after operation)
- overal survival(3 years after operation)
- disease-free survival(3 years after operation)
- complications(30 days after operation)
研究者
Zhen Jun Wang
Chairman of General Surgery
Beijing Chao Yang Hospital
