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Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma

Study acronym: RADIOSONIC
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jul 2028 to Jun 20, 2029
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2023 to Jun 20, 2023
    v3
  2. Study title shortened, about 9 wordsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05561634
Lead Sponsor University Hospital, Lille
Collaborators: Sun Pharmaceutical Industries Limited
Conditions
(from sponsor)		 Basal Cell Carcinoma, Radiotherapy; Complications
Related terms Basal Cell Carcinoma
Enrollment 82 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov