Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma

Phase 2

Not yet recruiting

• Conditions: Basal Cell Carcinoma; Radiotherapy; Complications
• Interventions: Radiation: Radiotherapy; Other: Observation; Drug: Vismodegib

• Registration Number: NCT05561634
• Lead Sponsor: University Hospital, Lille

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-29
• Study First Posted: 2022-09-30
• Last Update Submitted: 2022-09-30
• Last Update Posted: 2022-10-03
• Study Start: 2023-07
• Primary Completion: 2028-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHHI then follow-up	Radiotherapy	-
SHHI then follow-up	Observation	-
SHHI then radiotherapy	Radiotherapy	-
SHHI then radiotherapy	Vismodegib	-

Primary Outcome Measures

Name	Time	Method
Occurrence of a local relapse at 2 years in both groups.	At 2 years

Secondary Outcome Measures

Name	Time	Method
Occurrence of local relapse at 1 and 3 years.	at 1 year and at 3 years
Occurrence of adverse effects in the radiotherapy group.	at 1 year, at 2 years and at 3 years