Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma

Basal Cell Carcinoma Clinical Trial

— RADIOSONIC  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05561634
• Other study ID #: 2021_0710
• Secondary ID: 2022-A01424-39
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2023
• Est. completion date: July 2028

Study information

• Verified date: September 2022
• Source: University Hospital, Lille
• Contact: Laurent Mortier, MD,PhD
• Phone: 0320445962
• Email: laurent.mortier[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: July 2028
• Est. primary completion date: July 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Radiotherapy; Complications

Intervention

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

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Sun Pharmaceutical Industries Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of a local relapse at 2 years in both groups.		At 2 years
Secondary	Occurrence of local relapse at 1 and 3 years.		at 1 year and at 3 years
Secondary	Occurrence of adverse effects in the radiotherapy group.		at 1 year, at 2 years and at 3 years