Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-20

Study Completion Date

2029-06-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Basal Cell Carcinoma Radiotherapy; Complications

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHHI then follow-up

Group Type SHAM_COMPARATOR

Radiotherapy

Intervention Type RADIATION

Irradiation of the tumoral bed.

Observation

Intervention Type OTHER

Patients will be followed up in consultation every 3 months.

SHHI then radiotherapy

Group Type EXPERIMENTAL

Radiotherapy

Intervention Type RADIATION

Irradiation of the tumoral bed.

Vismodegib

Intervention Type DRUG

Sonic Hedgehog inhibitors (SHHi) = Vismodegib et Sonidegib,

Interventions

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Radiotherapy

Irradiation of the tumoral bed.

Intervention Type RADIATION

Observation

Patients will be followed up in consultation every 3 months.

Intervention Type OTHER

Vismodegib

Sonic Hedgehog inhibitors (SHHi) = Vismodegib et Sonidegib,

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient over 18 years
* Locally advanced non-recurrent BCC in complete response after first course of SHHi
* Complete response has to be confirmed histologically
* Available photography or CT scan before SHHi treatment allowing delineation of the initial tumor

Exclusion Criteria

* Patients with distant metastasis
* Patients with Gorlin's syndrome
* Prior radiotherapy to the region of the studied cancer that would result in overlap of radiation therapy fields
* Pregnant women
* Life expectancy less than 1 year
* Inability to receive informed consent
* Inability to participate in the entire study
* Lack of social security coverage
* Refusal to sign consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No