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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05374044
• Other study ID #: SF2020-1-2151
• Status: Active, not recruiting
• Start date: May 18, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Peking University Cancer Hospital & Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 385
• Est. completion date: December 31, 2025
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking University Shougang Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute	Capital's Funds for Health Improvement and Research (2020-1- 2151).

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Death	all cause death	3 years from the data of surgery
Secondary	local recurrence		3 years from the data of surgery