Clinical trial · Interventional
Radiotherapy by Sonic Hedgehog Pathway Inhibitors in 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Radiotherapy; Complications | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation | Other | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Vismodegib | Drug | Vismodegib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- SHAM_COMPARATOR
- label
- SHHI then follow-up
- interventionNames
- Radiation: Radiotherapy
- Other: Observation
- type
- EXPERIMENTAL
- label
- SHHI then radiotherapy
- interventionNames
- Radiation: Radiotherapy
- Drug: Vismodegib
Primary outcomes (1)
- measure
- Occurrence of a local relapse at 2 years in both groups.
- timeFrame
- At 2 years
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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