Assessment of Complete Response MRI Criterion After Neoadjuvant Therapy in Locally Advanced Rectal Cancer

Completed

• Conditions: Rectal Neoplasms

• Registration Number: NCT05534841
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

Standard care for locally advanced rectal cancer consists in a neoadjuvant therapy followed by surgery. Morbidity and mortality remain high after rectal surgery, and often linked with quality of life impairment. 10 to 30% present a pathological complete response after neoadjuvant therapy. Some surgical teams propose "watch and wait" approach for patients selected with clinical complete responses criterion. The problem is to be sur the response is complete. MRI seems to be accurate to select complete responders. We will try to find MRI criterion of complete responses.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2022-08-12
• Study Completion: 2022-08-12
• Status Verified: 2022-09
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-08
• Last Update Submitted: 2022-09-08
• Study First Posted: 2022-09-10
• Last Update Posted: 2022-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Rectal adenocarcinoma
• Locally advanced
• Neoadjuvant therapy
• MRI restaging
• Rectal surgery
• Definitive anatomopathology study

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete response MRI criterion	Day 0: immediately after the procedure	We selected several objective MRI criterion among literature and compared them between the two groups.

Secondary Outcome Measures

Name	Time	Method
MRI accuracy	Day 0: immediately after the procedure	Calculated Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value.

Trial Locations

Locations (1)

Chu de Nîmes; 🇫🇷 Nîmes, Gard, France