Radiation after Sonic Hedgehog inhibitor response for locally advanced 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
This trial tests whether giving radiotherapy after a complete response to Sonic Hedgehog inhibitors (vismodegib or sonidegib) helps people with locally advanced basal cell carcinoma stay cancer-free.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Lille) |
| Trial ID | NCT05561634 on ClinicalTrials.gov |
What this trial studies
This is a prospective multicenter Phase 2 study enrolling adults with locally advanced, non-recurrent basal cell carcinoma who achieved a histologically confirmed complete response after a first course of Sonic Hedgehog inhibitors. Eligible participants have pre-treatment photographs or CT scans to allow delineation of the original tumor and no prior overlapping radiotherapy to the region. Enrolled patients receive consolidation radiotherapy after SHHi-induced complete response and are followed with clinical exams and imaging to monitor for relapse and treatment-related toxicity. Outcomes will focus on relapse rates after treatment discontinuation and the safety/tolerability of adding radiotherapy in this setting.
Who should consider this trial
Good fit: Adults (≥18) with locally advanced, non-recurrent BCC who achieved a histologically confirmed complete response after a first course of a Sonic Hedgehog inhibitor and who have pre-treatment photos or CT for tumor delineation are ideal candidates.
Not a fit: Patients with distant metastases, Gorlin's syndrome, prior overlapping radiotherapy to the region, pregnant women, those with life expectancy under one year, or those unable/unwilling to consent or participate are not eligible and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, consolidation radiotherapy could lower the high relapse rate seen after stopping Sonic Hedgehog inhibitors and reduce the need to restart systemic therapy.
How similar studies have performed: A few case reports have suggested combining vismodegib with radiotherapy can improve response, but there are no prior prospective studies specifically testing consolidation radiotherapy after complete response, so evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lille
- CHU Lille — Lille, France (Recruiting)
Study contacts
- Principal investigator: Laurent Mortier, MD,PhD — University Hospital, Lille
- Study coordinator: Laurent Mortier, MD,PhD
- Email: laurent.mortier@chru-lille.fr
- Phone: 0320445962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.