Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-24 @ 7:06 PM
NCT ID:
NCT06740357
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Patients with a history of chemotherapy or pelvic irradiation (excluding neoadjuvant treatment)
* Contraindication to pelvic MRI
* Patients with MSI status undergoing immunotherapy
* 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
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06740357
Study Brief:
Protocol Section:
NCT06740357