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临床试验/NCT03504449
NCT03504449Unknown不适用

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

Beijing Chao Yang Hospital1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2016年12月1日最近更新:
适应症

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

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

发起方
Beijing Chao Yang Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhen Jun Wang

Chairman of General Surgery

Beijing Chao Yang Hospital

研究点 (1)

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