NCT06740357Recruiting
Implementation of a Tumor Response Assessment Program Integrating the Shared Medical Decision Into the Organ Preservation Strategy for Rectal Cancer Patients
Implementation of a Tumor Response Assessment Program Integrating Shared Medical Decision Making Into the Organ Preservation Strategy for Rectal Cancer Patients: Phase III Randomized - Multicenter
Source: ClinicalTrials.gov · Last updated 9 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- First submitted
- 13 Dec 2024
- Start date
- 10 Dec 2024
- Primary completion date
- Mar 2031
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Diseases
- Colorectal cancer
- NCT number
- NCT06740357
What you commit to
- Study type: Interventional
- Planned participants: 270
- From 10 Dec 2024 to the primary completion date, Mar 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with MSI status undergoing immunotherapy
Other illness
- Patients with a history of chemotherapy or pelvic irradiation (excluding neoadjuvant treatment)
- Other concomitant cancer or history of cancer within 5 years, with the exception of carcinoma in situ of the cervix or basal cell or squamous cell skin carcinoma or any other carcinoma in situ, considered cured
Other
- Contraindication to pelvic MRI
- Women who are pregnant, likely to become pregnant, or who are breast-feeding;
- Person under guardianship, curatorship or safeguard of justice, or person deprived of liberty.
- Unable to undergo medical follow-up for geographical, social or psychological reasons.
Who the study is looking for
- Patient aged 18 to 80
- Histologically proven lieberkuhnian adenocarcinoma with MSS status ;
- Patient who has or is due to receive neoadjuvant treatment (4 to 6 courses of (m)FOLFIRINOX or FOLFOX chemotherapy + CAP 50 radiochemotherapy or CAP 50 radiochemotherapy alone);
- BEFORE any neoadjuvant treatment:
- Tumor classified T2T3 (on MRI)
- N0-N1 (≤ 3 positive lymph nodes \* or size ≤ 8 mm) (on MRI)
- \* positive node = node size \> 5 mm minor axis and/or morphologically suspicious appearance Tumor size ≤4 cm (ON MRI)
- No distant metastasis (M0)\_ TAP scan or PET scan
- ≤ 8 cm from anal margin (On MRI) (Clinical examination\*)
- \*if the clinical examination is not possible, then the source data is that of the MRI.
- No invasion of the anal canal and/or sphincters (internal and external) (On MRI)
- Operable patient
- Ability to comply with the protocol and follow-up appointments (repeated assessment consultations and close follow-up if randomized to the Experimental Group);
- Person affiliated with or benefiting from a social security scheme;
- Free and informed consent signed by the patient.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Dijon Bourgogne Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.