Actively Recruiting
Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2023-11-30
303
Participants Needed
1
Research Sites
228 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 70 years or older
- Performance status OMS 0-3
- Pathology confirmed invasive squamous cell carcinoma or basal cell carcinoma
- At least one high-risk factor for recurrence (close margins, tumor location/size, microscopic perineural invasion, recurrent primary disease, immunosuppression, tumor thickness, or poor/moderate differentiation)
- No need for regional nodal radiotherapy
- No prior radiotherapy to the treated site
- Written consent provided by patient or legal representative
- Life expectancy of at least 6 months as estimated by investigator
- No contraindications for surgery and radiotherapy after multidisciplinary evaluation
- Affiliated to a social security scheme
You will not qualify if you...
- Macroscopic incomplete tumor resection (R1 or greater)
- Severe dementia preventing follow-up
- Psychological, familial, sociological, geographical, or logistical reasons preventing participation in treatment and follow-up
- Presence of other active cancers under treatment
- Participation in another therapeutic interventional study interfering with endpoints
- Patient receiving state medical aid (AME)
- Persons deprived of liberty by judicial or administrative decision
AI-Screening
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Trial Site Locations
Total: 1 location
1
Henri Mondor
Créteil, France, 94000
Actively Recruiting
Research Team
Y
YAZID BELKACEMI, MD, PhD
CONTACT
F
France GUYOT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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