Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille

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

Qualifiers

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

Treatments tested in this trial

  • Radiotherapy
  • Observation
  • Vismodegib

Treatment groups

82 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Lille

Lead sponsor

Sun Pharmaceutical Industries Limited

Collaborator