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

NCT ID: NCT05534841

Last Updated: 2022-09-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 99 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-08-12

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.

Conditions

Rectal Neoplasms

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Pathological complete response

Patients with a complete response to the neoadjuvant therapy on the definitive anatomopathology study.

No interventions assigned to this group

Non pathological complete response

Patients without complete response to the neoadjuvant therapy on the definitive anatomopathology study.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu de Nîmes

Nîmes, GARD, France

Countries

France

Other Identifiers

22.03.05

Identifier Type: -

Identifier Source: org_study_id