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 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT05794035
Eligibility Criteria:
Inclusion Criteria:
* Patients aged ≥ 70 years
* OMS 0-3
* Pathology confirmation of invasive SCC or BCC
* At least one of high-risk factors for recurrence (R0 but close margins, location/size, microscopic perineural invasion, recurrent primary disease, immunosuppression, thickness including Breslow and Clark level, poorly-moderately differentiated)
* No indication of regional nodal RT
* No prior RT to the treated site
* Written consent from patient or his/her legal representative, trustworthy person or family member if the person is physically unable to give his or her written consent
* Life expectancy ≥ 6 months, as clinically estimated by the investigator in charge of enrolment
* No contraindication for surgery and RT after multidisciplinary board meeting evaluation
* Affiliated to a social security scheme
Exclusion Criteria:
* Macroscopic incomplete resection of the primary tumor (≥ R1)
* Patient with severe dementia not allowing follow-up
* Any psychological, familial, sociological, geographical or logistical reasons that would prevent participation to surveillance during treatment and follow-up
* Other active cancers in treatment
* Participation in another interventional study (therapeutic trial interfering with the study's endpoints)
* Patient on AME (state medical aid)
* Persons deprived of their liberty by a judicial or administrative decision
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT05794035
Study Brief:
Protocol Section:
NCT05794035