About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient over 18 years
Locally advanced non-recurrent BCC in complete response after first course of SHHi
Complete response has to be confirmed histologically
Available photography or CT scan before SHHi treatment allowing delineation of the initial tumor
Disqualifiers
Patients with distant metastasis
Patients with Gorlin's syndrome
Prior radiotherapy to the region of the studied cancer that would result in overlap of radiation therapy fields
Pregnant women
Trial design
Parallel
Treatments tested in this trial
Radiotherapy
RadiationIrradiation of the tumoral bed.
Observation
Other interventionPatients will be followed up in consultation every 3 months.
Vismodegib
DrugSonic Hedgehog inhibitors (SHHi) = Vismodegib et Sonidegib,
Treatment groups
Trial outcomes
Primary outcomes
Occurrence of a local relapse at 2 years in both groups.
Secondary outcomes
Occurrence of local relapse at 1 and 3 years.
Occurrence of adverse effects in the radiotherapy group.
Sponsors and contacts
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University Hospital, Lille
Lead sponsor
Sun Pharmaceutical Industries Limited
Collaborator