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:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-25 @ 2:25 AM
NCT ID:
NCT05591534
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven rectal adenocarcinoma
* Tumor cT2T3Tumor N0 or N1, M0
* Size \< 6cm and \< 50% of circumference at initial workup, location ≤ 10 cm from anal margin
* Partial response assessed on MRI 3-8 weeks after completion of external beam radiation therapy
* Resolved rectal toxicity from external radiotherapy (grade ≤ 1) at the time of inclusion
* ECOG performance index ≤ 2
* Patient ≥ 18 years of age
* Patient likely to receive radiation therapy
* Effective contraception for patients of childbearing potential: male patients and women of childbearing potential must agree to use two medically validated methods of contraception (one for the patient and one for the partner) during treatment and at least until 6 months after the last treatment
* Informing the patient and obtaining free, informed and written consent, signed by the patient and the investigator
* Subject affiliated or beneficiary of a social security system of a member state of the European Community (article L1121-11 of the Public Health Code)
Exclusion Criteria:
* T1 or T4 tumor
* Tumor size \> 6 cm or \> 50% of circumference at initial workup
* Invaded external sphincter or levator ani
* N2 tumor (\> 3 positive nodes)
* Upper rectal tumor (\> 10 cm from anal margin)
* Metastatic disease
* Contraindication to radiotherapy
* Unusual and unresolved rectal toxicity from external radiation therapy (\> grade 1) at the time of inclusion
* Pregnant, potentially pregnant, or breastfeeding women
* Persons deprived of liberty or under guardianship or unable to give consent
* Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05591534
Study Brief:
Protocol Section:
NCT05591534