NCT05794035 Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients
| NCT ID | NCT05794035 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Skin Cancer, Non-Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 303 participants |
| Start Date | 2023-10-17 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 303 participants in total. It began in 2023-10-17 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 of ART, multiple fractionation schedules are available, ranging from standard fractionation (45-60Gy in 5-6 weeks) to the extreme hypofractionation (HF) delivering 16-18Gy in one fraction. In routine practice, HF is mainly preferred in elderly patients for more convenience by reducing the number of transports and increase health related quality of life (HRQoL). However, there is no data on the fragility profiles of these patients, nor validating any HF schedule in terms of efficacy, acute toxicity, cosmetic results, and impact on HRQoL. the main ain objective is to evaluate the comparative efficacy of two modalities of Radiotherapy over surgery alone on local tumor control in older patients with Non Melanoma Skin Cancer (NMSC) In current practice, adjuvant radiotherapy is discussed regarding the risk of local recurrence as determined by the existence (or not) of unfavorable prognostic factors. The proposed study will include R0-high risk of CBC and CEC of the skin in elderly patients. There is no risk regarding the design of the trial as the last will respond to two important unknown questions regarding the utility of RT and its fractionation in this population. Moreover, it is an excellent opportunity to collect prospectively geriatric evaluation and HRQoL data that are lacking in the literature for skin cancers. No constraints are seen neither in the design, nor in the potential recruitments.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05794035 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Skin Cancer, Non-Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05794035 currently recruiting?
Yes, NCT05794035 is actively recruiting participants. Contact the research team at yazid.belkacemi@aphp.fr for enrollment information.
Where is the NCT05794035 trial being conducted?
This trial is being conducted at Créteil, France.
Who is sponsoring the NCT05794035 clinical trial?
NCT05794035 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 303 participants.
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