Actively Recruiting
Implementation of a Tumor Response Assessment Program Integrating the Shared Medical Decision Into the Organ Preservation Strategy for Rectal Cancer Patients
Led by Centre Hospitalier Universitaire Dijon · Updated on 2025-04-09
270
Participants Needed
1
Research Sites
324 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Implementation of a Tumor Response Assessment Program Integrating the Shared Medical Decision Into the Organ Preservation Strategy for Rectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 to 80
- Histologically confirmed lieberkuhnian adenocarcinoma with MSS status
- Has received or is scheduled to receive neoadjuvant treatment (4 to 6 courses of (m)FOLFIRINOX or FOLFOX chemotherapy plus CAP 50 radiochemotherapy or CAP 50 radiochemotherapy alone)
- Tumor classified as T2 or T3 on MRI before neoadjuvant treatment
- N0-N1 status with no more than 3 positive lymph nodes or node size no larger than 8 mm on MRI
- Positive node defined as size greater than 5 mm minor axis and/or suspicious morphology
- Tumor size 4 cm or less on MRI
- No distant metastasis (M0) confirmed by TAP scan or PET scan
- Tumor located 8 cm or less from the anal margin on MRI or clinical examination
- No invasion of the anal canal or sphincters on MRI
- Operable patient
- Ability to comply with the study protocol and follow-up appointments
- Affiliated with or benefiting from a social security scheme
- Signed free and informed consent
You will not qualify if you...
- History of chemotherapy or pelvic irradiation except for current neoadjuvant treatment
- Contraindication to pelvic MRI
- MSI status with immunotherapy treatment
- Other current cancer or cancer history within 5 years except cured carcinoma in situ of cervix or certain skin carcinomas
- Women who are pregnant, likely to become pregnant, or breastfeeding
- Under guardianship, curatorship, or legal protection, or deprived of liberty
- Unable to undergo medical follow-up due to geographic, social, or psychological reasons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHU Dijon Bourgogne
Dijon, France, 21000
Actively Recruiting
Research Team
Q
Quentin DENOST
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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