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Clinical Trials/NCT05534841
NCT05534841
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Nīmes1 site in 1 country99 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rectal Neoplasms
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
99
Locations
1
Primary Endpoint
Complete response MRI criterion
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
August 12, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Complete response MRI criterion

Time Frame: Day 0: immediately after the procedure

We selected several objective MRI criterion among literature and compared them between the two groups.

Secondary Outcomes

  • MRI accuracy(Day 0: immediately after the procedure)

Study Sites (1)

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