Locally advanced basal cell carcinoma (BCC) are large BCCs or BCCs located in areas subject to functional and aesthetic risk following surgery or radiotherapy. In these particular situations, surgery and radiotherapy are sometimes not appropriate, and Sonic Hedgehog inhibitors (SHHi) (Vismodegib and Sonidegib) can be proposed. SHHi are effective treatments in laBCC but most CR patients discontinue treatment because of tolerability. Approximately 65% of the population experience a relapse after discontinuation. A few cases of patients treated concomitantly by radiotherapy and vismodegib have been reported in the literature, suggesting that combining vismodegib and concomitant radiotherapy results in an improved overall response compared to a single modality treatment. There is no study evaluating a "consolidation radiotherapy" after complete response to SHHi. We carry out a prospective multicenter study in order to evaluate consolidation radiotherapy in patients with laBCC after achieving complete response with SHHi, with the hypothesis of reducing recurrence after discontinuation of SHHi.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Irradiation of the tumoral bed.
Patients will be followed up in consultation every 3 months.
Sonic Hedgehog inhibitors (SHHi) = Vismodegib et Sonidegib,
CHU Lille
Lille, France
RECRUITINGOccurrence of a local relapse at 2 years in both groups.
Time frame: At 2 years
Occurrence of local relapse at 1 and 3 years.
Time frame: at 1 year and at 3 years
Occurrence of adverse effects in the radiotherapy group.
Time frame: at 1 year, at 2 years and at 3 years
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