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SCRM-01: 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

Sponsor
Beijing Chao Yang Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03504449
Collaborator
(none)
350
Enrollment
1
Location
2
Arms
72
Anticipated Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: neoadjuvant chemoradiotherapy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Actual Study Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: surgery without neoadjuvant chemoradiotherapy

For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery without neoadjuvant chemoradiotherapy.

Other: neoadjuvant chemoradiotherapy
Experimental: surgery with neoadjuvant chemoradiotherapy

For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery following neoadjuvant chemoradiotherapy.

Other: neoadjuvant chemoradiotherapy

Outcome Measures

Primary Outcome Measures

  1. circumferential resection margin [one week after operation]

  2. introperative perforation [During the operation]

Secondary Outcome Measures

  1. local recurrece [3 years after operation]

  2. overal survival [3 years after operation]

  3. disease-free survival [3 years after operation]

  4. complications [30 days after operation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Tumor within 12 cm of the anal verge

  2. T3N1-2 as determined by preoperative MRI examination

  3. negative circumferential resection margin determined by preoperative MRI examination

  4. Absence of distant metastases

  5. Absence of intestinal obstruction

Exclusion Criteria:

  1. With distant metastases

  2. With intestinal obstruction

  3. Pregnancy or lactation

  4. With operation contraindication

  5. With mental disorder

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Chaoyang Hospital Beijing Beijing China 100020

Sponsors and Collaborators

  • Beijing Chao Yang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhen Jun Wang, Chairman of General Surgery, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT03504449
Other Study ID Numbers:
  • SCRM-01
First Posted:
Apr 20, 2018
Last Update Posted:
Feb 8, 2021
Last Verified:
Feb 1, 2021
Additional relevant MeSH terms:
Neoplasms
Recurrence

Study Results

No Results Posted as of Feb 8, 2021