IMPACTE-01

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.

After inclusion of patient aged ≥ 70 years with performance status OMS 0-3 who had completed surgery (R0) for SCC and BCC with at least one unfavorable prognostic factor, all patientsst will have G8 score and a Geriatric Core Data Set (G CODE) evaluation. Performance of a complete oncogeriatric evaluation and its modalities will be left to the discretion of the investigator.

The patients will be randomized in 3 arms with stratification by center, time from surgery to wound healing and perineural invasion.
– Arm A: Surgery alone.
– Arm B: Surgery + Moderate HF 45Gy in 15 fractions, 3 fractions per week over 5 weeks to the operative bed.
– Arm C: Surgery + Extreme HF : 30Gy in 5 fractions of 6Gy, 1 fraction per week, over 5 weeks to the operative bed.

1. Patients aged ≥ 70 years.
2. OMS 0-3.
3. Pathology confirmation of invasive SCC or BCC.
4. 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).
5. No indication of regional nodal RT.
6. No prior RT to the treated site.
7. 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.
8. Life expectancy ≥ 6 months, as clinically estimated by the investigator in charge of enrolment.
9. No contraindication for surgery and RT after multidisciplinary board meeting evaluation.
10. Affiliated to a social security scheme.

1. Macroscopic incomplete resection of the primary tumor (≥ R1).
2. Patient with severe dementia not allowing follow-up.
3. Any psychological, familial, sociological, geographical or logistical reasons that would prevent participation to surveillance during treatment and follow-up.
4. Other active cancers in treatment.
5. Participation in another interventional study (therapeutic trial interfering with the study’s endpoints).
6. Patient on AME (state medical aid).
7. Persons deprived of their liberty by a judicial or administrative decision.

Lancement de l’étude : Octobre 2023
Fin estimée des inclusions : Mars 2028
Nombre de patients à inclure : 303

Pr Yazid BELKACEMI – AP-HP – Hôpital Henri Mondor-Albert Chenevier

AP-HP