Impact of hypofractionated radiotherapy after surgery for skin cancer in older patients
Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients IMPACTE-01
This study is testing if a special type of radiation therapy after surgery can help older patients with skin cancer feel better and live healthier lives compared to just having surgery alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 303 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Créteil) |
| Trial ID | NCT05794035 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 70 and older with confirmed invasive squamous cell carcinoma or basal cell carcinoma and at least one high-risk factor for recurrence.
Not a fit: Patients with macroscopic incomplete resection of the primary tumor or severe dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and quality of life for elderly patients with high-risk non-melanoma skin cancer.
How similar studies have performed: While there is limited high-level evidence regarding hypofractionated radiotherapy in this specific population, similar approaches have shown promise in other studies focusing on older patients with cancer.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Créteil
- Henri Mondor — Créteil, France (Recruiting)
Study contacts
- Study coordinator: YAZID BELKACEMI, MD, PhD
- Email: yazid.belkacemi@aphp.fr
- Phone: 1 49 81 45 22
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.