Back to resultsSurgery 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 (SCRM-01)
Primary Purpose
Circumferential Resection Margin, Intraoperative Perforation of Rectum, Local Recurrence of Malignant Tumor of Rectum
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
neoadjuvant chemoradiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Circumferential Resection Margin
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
Sites / Locations
- Beijing Chaoyang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
surgery without neoadjuvant chemoradiotherapy
surgery with neoadjuvant chemoradiotherapy
Arm Description
For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery without neoadjuvant chemoradiotherapy.
For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery following neoadjuvant chemoradiotherapy.
Outcomes
Primary Outcome Measures
circumferential resection margin
introperative perforation
Secondary Outcome Measures
local recurrece
overal survival
disease-free survival
complications
Full Information
NCT ID
NCT03504449
First Posted
April 12, 2018
Last Updated
February 4, 2021
Sponsor
Beijing Chao Yang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03504449
Brief Title
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
Acronym
SCRM-01
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circumferential Resection Margin, Intraoperative Perforation of Rectum, Local Recurrence of Malignant Tumor of Rectum, Disease-free Survival, Overal Survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
surgery without neoadjuvant chemoradiotherapy
Arm Type
Experimental
Arm Description
For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery without neoadjuvant chemoradiotherapy.
Arm Title
surgery with neoadjuvant chemoradiotherapy
Arm Type
Experimental
Arm Description
For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery following neoadjuvant chemoradiotherapy.
Intervention Type
Other
Intervention Name(s)
neoadjuvant chemoradiotherapy
Primary Outcome Measure Information:
Title
circumferential resection margin
Time Frame
one week after operation
Title
introperative perforation
Time Frame
During the operation
Secondary Outcome Measure Information:
Title
local recurrece
Time Frame
3 years after operation
Title
overal survival
Time Frame
3 years after operation
Title
disease-free survival
Time Frame
3 years after operation
Title
complications
Time Frame
30 days after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiagang Han, MD
Phone
+861085231604
Email
wzhj611@163.com
Facility Information:
Facility Name
Beijing Chaoyang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiagang Han, Professor
Phone
8613522867841
Email
hjg211@163.com
First Name & Middle Initial & Last Name & Degree
Jiagang Han, Professor
First Name & Middle Initial & Last Name & Degree
Zhenjun Wang, professor
First Name & Middle Initial & Last Name & Degree
Guanghui WEI, Professor
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs