NCT05561634 Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma
| NCT ID | NCT05561634 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Lille |
| Condition | Basal Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2023-06-20 |
| Primary Completion | 2029-06-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 82 participants in total. It began in 2023-06-20 with a primary completion date of 2029-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Laurent Mortier, MD,PhD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT05561634 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Basal Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05561634 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05561634 currently recruiting?
Yes, NCT05561634 is actively recruiting participants. Contact the research team at laurent.mortier@chru-lille.fr for enrollment information.
Where is the NCT05561634 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT05561634 clinical trial?
NCT05561634 is sponsored by University Hospital, Lille. The principal investigator is Laurent Mortier, MD,PhD at University Hospital, Lille. The trial plans to enroll 82 participants.