Radiation after Sonic Hedgehog inhibitor response for locally advanced basal cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.