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

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.

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Key information

Conditions

Rectal Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Disease Progression Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Complete Response Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Nîmes

Nîmes, GARD, 30000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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

Time frame: Day 0: immediately after the procedure

Calculated Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Sep 10, 2022
Registry last updated: Sep 10, 2022

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed