Implementation of a Tumor Response Assessment Program Integrating the Shared Medical Decision Into the Organ Preservation Strategy for Rectal Cancer Patients

NARecruitingINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

December 10, 2024

Primary Completion Date

March 31, 2031

Study Completion Date

March 31, 2031

Conditions
Rectal Cancer
Interventions
OTHER

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

OTHER

Standard evaluation of tumor response

Assessment at 2 months (+/- 7 days) after neoadjuvant treatment: digital rectal exam, pelvic MRI, rectoscopy, TAP scan

OTHER

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.

OTHER

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).

OTHER

Follow-up

Every 3 months for 2 years, then every 6 months for the third year

Trial Locations (1)

21000

RECRUITING

CHU Dijon Bourgogne, Dijon

All Listed Sponsors
lead

Centre Hospitalier Universitaire Dijon

OTHER