RecruitingPhase 2NCT05561634

Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma

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


Sponsor

University Hospital, Lille

Enrollment

82 participants

Start Date

Jun 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether radiation therapy can help prevent basal cell carcinoma (BCC) — a common type of skin cancer — from coming back after patients achieved a complete response to a type of targeted drug therapy (called Sonic Hedgehog pathway inhibitors, or SHHi). The goal is to see if radiation after drug treatment offers a lasting cure. **You may be eligible if...** - You are over 18 years old - You have locally advanced BCC (not a recurrent case) that responded completely to the first course of SHHi treatment - The complete response was confirmed by a biopsy - Photos or scans taken before your drug treatment are available so doctors can plan your radiation **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body - You have Gorlin syndrome (a rare genetic condition linked to multiple BCCs) - You previously had radiation in the same area of the body - You are pregnant - Your life expectancy is less than 1 year - You are unable to complete the full study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiotherapy

Irradiation of the tumoral bed.

OTHERObservation

Patients will be followed up in consultation every 3 months.

DRUGVismodegib

Sonic Hedgehog inhibitors (SHHi) = Vismodegib et Sonidegib,


Locations(1)

CHU Lille

Lille, France

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NCT05561634


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