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RECRUITING
NCT05561634
PHASE2

Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

Summary

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.

Official title: Evaluation of Radiotherapy After Complete Response to Sonic Hedgehog Pathway Inhibitors in Patients With Locally Advanced Basal Cell Carcinoma: a Prospective Multicenter Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2023-06-20

Completion Date

2029-06-20

Last Updated

2025-09-30

Healthy Volunteers

No

Interventions

RADIATION

Radiotherapy

Irradiation of the tumoral bed.

OTHER

Observation

Patients will be followed up in consultation every 3 months.

DRUG

Vismodegib

Sonic Hedgehog inhibitors (SHHi) = Vismodegib et Sonidegib,

Locations (1)

CHU Lille

Lille, France