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

NCT06740357 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2025-04-09

No results posted yet for this study

Summary

The adoption of total mesorectal excision (TME) has standardized rectal cancer surgery and improved oncological outcomes. In locally advanced rectal cancer, neoadjuvant radio chemotherapy (NACRT) has further improved oncological benefit. Although these strategies result in good 5-year disease-free survival rates, they are associated with significant morbidity, in particular permanent long-term bowel, urinary and sexual dysfunction. In rectal cancer management, the main objective of organ preservation is to avoid or reduce morbidity and impact on quality of life after rectal resection, without compromising oncological outcomes.

The aim of this project is to evaluate the efficacy of a defined response monitoring program, including a shared decision process, as a strategy for assessing tumor response in locally advanced rectal cancer after neoadjuvant therapy.

This is a national, phase III, randomized, open-label, multicenter clinical trial comparing the tumor response monitoring program with shared decision-making, versus standard tumor response assessment in organ preservation strategies in rectal cancer.

Conditions

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2031-03-31
Completion
2031-03-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06740357 on ClinicalTrials.gov