Informations générales (source: ClinicalTrials.gov)
Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients IMPACTE-01
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
octobre 2023
mars 2028
13 septembre 2025
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.
Etablissements
Critères
Tous
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
- 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
- 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