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

Establishment of a Quantified Imaging Method for Evaluating Tumor Response Grade in Rectal Cancer Patient With Neoadjuvant Therapy: a Multi-center Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Diagnostic test: pelvic MRI for establishing new mrTRG method

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 Type: Observational
• Enrollment (Actual): 385

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100039
      • Chinese PLA General Hospital
    • Beijing, Beijing, China, 100142
      • Peking University Shougang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

biopsy-proved primary locally advanced rectal adenocarcinoma(cT3 and/or cN+)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
rectal cancer with NAT; The patients are planned to receive neoadjvant therapy, and then receive radical surgery.	Diagnostic test: pelvic MRI for establishing new mrTRG method; they will received two pelvic MR examinations before and after neoadjvant therapy. The MRI before neoadjvant therapy is considered as baseline MRI, which is usually taken within 3 weeks before NAT. The MRI after neoadjvant therapy is considered as preoperative MRI, which is usually taken within 3-8 weeks before NAT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pathological tumor regression grade(pTRG)	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.	within 2 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
distant metastasis	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	3 years from the data of surgery
Death	all cause death	3 years from the data of surgery
local recurrence		3 years from the data of surgery

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Collaborators: Capital's Funds for Health Improvement and Research (2020-1- 2151).
• Investigators: Principal Investigator: Ying-Shi Sun, MD, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2020
• Primary Completion (Actual): April 30, 2023
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: rectal cancer; neoadjuvant therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: SF2020-1-2151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No