270
Participants
Start Date
December 10, 2024
Primary Completion Date
March 31, 2031
Study Completion Date
March 31, 2031
Tumor response monitoring program
three steps of tumor response evaluation (STEP 1 at 2 months, STEP 2 at 4 months, STEP 3 at 6 months after completion of neoadjuvant treatment): STEP 1: digital rectal examination, pelvic MRI, rectoscopy, TAP scan STEP 2: DRE, pelvic MRI, rectoscopy STEP 3: DRE, pelvic MRI, rectoscopy, TAP or PET scan
Standard evaluation of tumor response
Assessment at 2 months (+/- 7 days) after neoadjuvant treatment: digital rectal exam, pelvic MRI, rectoscopy, TAP scan
Shared decision-making
At each stage of the monitoring program and depending on the clinical and oncological results, the decision to preserve the rectum will be discussed with the patient according to a shared-decision program.
Decision-making according to national recommendations
The decision to preserve the rectum is based on assessment at 2 months after completion of neoadjuvant treatment (standard of care since the GRECCAR2 trial).
Follow-up
Every 3 months for 2 years, then every 6 months for the third year
RECRUITING
CHU Dijon Bourgogne, Dijon
Centre Hospitalier Universitaire Dijon
OTHER