Actively Recruiting
Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma
Led by University Hospital, Lille · Updated on 2025-09-30
82
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
S
Sun Pharmaceutical Industries Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years
- Locally advanced non-recurrent basal cell carcinoma in complete response after first course of Sonic Hedgehog inhibitors
- Complete response confirmed by biopsy
- Available photography or CT scan before treatment to outline the initial tumor
You will not qualify if you...
- Distant metastasis
- Gorlin's syndrome
- Prior radiotherapy to the region causing overlap of radiation fields
- Pregnant women
- Life expectancy less than 1 year
- Unable to give informed consent
- Unable to participate in entire study
- Lack of social security coverage
- Refusal to sign consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHU Lille
Lille, France
Actively Recruiting
Research Team
L
Laurent Mortier, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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