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Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma

NCT05561634 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-09-30

No results posted yet for this study

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.

Conditions

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,

Sponsors & Collaborators

  • Sun Pharmaceutical Industries Limited

    collaborator INDUSTRY

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Laurent Mortier, MD,PhD · University Hospital, Lille

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-20
Primary Completion
2029-06-20
Completion
2029-06-20

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05561634 on ClinicalTrials.gov