Establishment of MRI Model for pTRG in Rectal Cancer With Establishment of

Active, not recruiting

• Conditions: Rectal Cancer

• Registration Number: NCT05374044
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

This study proposeto integrate a variety of imaging quantitative indicators to establish a new MRI-based tumor response regression(mrTRG) classification method. The accuracy of the established mrTRG classification method according pathology TRG(pTRG) will be tested. The ability of the established mrTRG classification method to predict prognosis will also be tested.

Detailed Description

The study included two part: one is a retrospective single-center cohort for analyzing quantitative MRI factors associated with pTRG, from which a new MRI-based tumor response regression(mrTRG) classification method will be established. The other is a prospective multi-center cohort for testing the accuracy of the established mrTRG classification according to pTRG; and also for validating the established mrTRG classification associated with survival.

Study Timeline

• Study Start: 2020-05-18
• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-13
• Primary Completion: 2023-04-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-19
• Last Update Posted: 2023-06-22
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 385

Inclusion Criteria

• biopsy-proved primary rectal cancer
• baseline MRI confirmed LARC (cT3 and/or cN+)
• scheduled to take neoadjuvant therapy
• receive baseline and preoperative pelvic MRI
• receive TME surgery after NAT
• have routine follow-up after the operation

Exclusion Criteria

• history of malignancy or multiple primary cancers
• receive surgery directly without NAT
• don't receive TME surgery
• don't complete NAT
• simultaneous distant metastasis at the baseline diagnosis
• lack of baseline or preoperative pelvic MRI
• incomplete or unavailable pathological information
• lost to follow-up within three months after surgery (lost since the first follow-up visit)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pathological tumor regression grade(pTRG)	within 2 weeks after surgery	pTRG is evaluated according to the AJCC system. pTRG0-1 is defined as good response, pTRG2 as moderate response, and pTRG3 as poor response. The pTRG is judged by two experienced pathologists working together. If there are any discrepancies, then a third senior pathologist is consulted for arbitration. there were any discrepancies, then a third senior pathologist was consulted. there were any discrepancies, then a third senior pathologist was consulted.

Secondary Outcome Measures

Name	Time	Method
local recurrence	3 years from the data of surgery
distant metastasis	3 years from the data of surgery	Distant metastastic lesion detected by follow-up CT which will be performed every 3 month for the first two year and every 6 month since the third year
Death	3 years from the data of surgery	all cause death

Trial Locations

Locations (3)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Shougang Hospital; 🇨🇳 Beijing, Beijing, China