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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT06692556
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥ 18 years of age at the time of signing informed consent to participate;
* Patient with histologically confirmed, localized skin squamous cell carcinoma; Note bene: patients with carcinoma of the external auditory canal may be included in the study;
* Patient treated with complete excision surgery (R0), regardless of margin (inframillimetric or supramillimetric);
* High risk disease defined by: presence of a microscopic PNI without/with another risk factor (among those mentioned below) OR presence of 2-3 risk factors other than microscopic PNI; Note Bene: The risk factors selected are immunosuppression (only haematopathy with or without treatment) , a tumor diameter \>20mm, specific location (lip/ear/temple), deep invasion (thickness \>6mm or invasion beyond subcutaneous fat), low differentiation or desmoplasia;
* Patient informed and having signed consent to participate in the study;
* Patient affiliated with a health insurance plan (or beneficiary of such a plan).
Exclusion Criteria:
* Patient with in situ or mixed SCC;
* History of SCC at high risk of relapse in the same territory (head and neck, trunk or limb) in the 2 years preceding the date of randomization;
* History of SCC having received systemic treatment;
* Patient with SCC located in the endonasal, intra-oral, anogenital or vulvar mucosa;
* Patient with recurrent SCC or SCC at very high risk of relapse defined by one of the following criteria:
* PNI with \> 2 other risk factors,
* \> 3 risk factors,
* bone invasion,
* immunosuppression by immunosuppressive treatments (whatever the reason).
* Patient with SCC with a single risk factor other than PNI;
* Patient with SCC with lymph node or distant metastasis;
* Patient with a history of solid cancer undergoing chemotherapy;
* Patient with a contraindication to radiotherapy;
* Patient with a history of radiotherapy in the area of the lesion;
* Participation in another clinical trial that may interfere with the assessment of the primary endpoint;
* Patient under guardianship or curatorship or deprived of liberty;
* Pregnant or breastfeeding woman.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06692556
Study Brief:
Protocol Section:
NCT06692556