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Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients

RecruitingNAAges 70 Years - anyAllAssistance Publique - Hôpitaux de Paris
NCT05794035 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Non-melanoma skin cancer (NMSC) incidence as well as morbidity rates are high in older patients. Surgery is the standard of care. About 5 to 10% of NMSC present high-risk clinico-pathologic features that can increase risk of local recurrence (LR). Adjuvant radiation therapy (ART) is often discussed regarding the risk of local recurrence. Despite the lack of high level evidence, ART is indicated in patients according to unfavorable prognostic factors. ART benefit is generally questioned in regard to the potential degradation of the patient's quality of life (QoL). Currently there is no prospective trial or recommendations that take into account geriatric patients' evaluation and profiles during the management of NMSC. In addition, there is no data that could help to define the subgroup of elderly patients who will benefit from ART in tumors with unfavorable prognostic factors. In terms

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📋 Eligibility rules (as published)
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
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What it tests

  • Surgery with additional moderate hypofractionation RT (15 fractions)
  • Surgery alone, without radiation post surgery
  • Surgery with extreme hypo fractionation treatment (HF)
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Where

1 site
Henri Mondor
Créteil, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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