RADIOSONIC: Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma

• Sponsor: University Hospital, Lille (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05561634
• Collaborator: Sun Pharmaceutical Industries Limited (Industry)
• Enrollment: 82
• Arms: 2
• Anticipated Duration (Months): 60

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Basal Cell Carcinoma; Radiotherapy; Complications	Radiation: Radiotherapy; Other: Observation; Drug: Vismodegib	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 82 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2028
• Anticipated Study Completion Date: Jul 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: SHHI then follow-up	Radiation: Radiotherapy; Irradiation of the tumoral bed.; Other: Observation; Patients will be followed up in consultation every 3 months.
Experimental: SHHI then radiotherapy	Radiation: Radiotherapy; Irradiation of the tumoral bed.; Drug: Vismodegib; Sonic Hedgehog inhibitors (SHHi) = Vismodegib et Sonidegib,

Outcome Measures

Primary Outcome Measures

1. Occurrence of a local relapse at 2 years in both groups. [At 2 years]

Secondary Outcome Measures

1. Occurrence of local relapse at 1 and 3 years. [at 1 year and at 3 years]

2. Occurrence of adverse effects in the radiotherapy group. [at 1 year, at 2 years and at 3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospital, Lille
• Sun Pharmaceutical Industries Limited

Investigators

• Principal Investigator: Laurent Mortier, MD,PhD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT05561634
• Other Study ID Numbers: 2021_0710; 2022-A01424-39
• First Posted: Sep 30, 2022
• Last Update Posted: Oct 3, 2022
• Last Verified: Sep 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Lille: Locally advanced basal cell carcinoma; Sonic Hedgehog inhibitors; Consideration radiotherapy
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Basal Cell

Study Results

No Results Posted as of Oct 3, 2022