Impact of hypofractionated radiotherapy after surgery for skin cancer in older patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of hypofractionated radiotherapy (RT) as an adjuvant treatment following surgery for non-melanoma skin cancer in patients aged 70 and older. It aims to identify which elderly patients with high-risk features benefit from this treatment while considering their quality of life. The study compares outcomes between patients receiving moderate hypofractionation, extreme hypofractionation, and those undergoing surgery alone. By focusing on geriatric patients, it seeks to fill a gap in current treatment protocols and provide tailored recommendations.

Why it matters

Who can join: the full rules

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

Where it's running

• Henri Mondor
  Créteil, France Recruiting

Study contacts

• Study coordinator: YAZID BELKACEMI, MD, PhD
• Email: yazid.belkacemi@aphp.fr
• Phone: 1 49 81 45 22

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.