Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiotherapy, Observation, Vismodegib.
- Who it may be relevant to
- Registry conditions: Basal Cell Carcinoma, Radiotherapy; Complications. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Radiation Radiotherapy
Irradiation of the tumoral bed. - Other Observation
Patients will be followed up in consultation every 3 months. - Drug Vismodegib
Sonic Hedgehog inhibitors (SHHi) = Vismodegib et Sonidegib,
Primary outcome measures
- Occurrence of a local relapse at 2 years in both groups. [Time frame: At 2 years]
Secondary outcome measures (2)
- Occurrence of local relapse at 1 and 3 years. [Time frame: at 1 year and at 3 years]
- Occurrence of adverse effects in the radiotherapy group. [Time frame: at 1 year, at 2 years and at 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU Lille — Lille
Identifiers
NCT: NCT05561634 · 2021_0710 · 2022-A01424-39