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Clinical Trials/NCT03504449
NCT03504449
Unknown
Not Applicable

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 site in 1 country350 target enrollmentDecember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Circumferential Resection Margin
Sponsor
Beijing Chao Yang Hospital
Enrollment
350
Locations
1
Primary Endpoint
circumferential resection margin
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2016
End Date
December 1, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Beijing Chao Yang Hospital
Responsible Party
Principal Investigator
Principal Investigator

Zhen Jun Wang

Chairman of General Surgery

Beijing Chao Yang Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • With distant metastases
  • With intestinal obstruction
  • Pregnancy or lactation
  • With operation contraindication
  • With mental disorder

Outcomes

Primary Outcomes

circumferential resection margin

Time Frame: one week after operation

introperative perforation

Time Frame: During the operation

Secondary Outcomes

  • local recurrece(3 years after operation)
  • overal survival(3 years after operation)
  • disease-free survival(3 years after operation)
  • complications(30 days after operation)

Study Sites (1)

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