Basal Cell Carcinoma, Radiotherapy; Complications
Conditions
Keywords
Locally advanced basal cell carcinoma, Sonic Hedgehog inhibitors, Consideration radiotherapy
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.
Interventions
RADIATIONRadiotherapy
Irradiation of the tumoral bed.
OTHERObservation
Patients will be followed up in consultation every 3 months.
DRUGVismodegib
Sonic Hedgehog inhibitors (SHHi) = Vismodegib et Sonidegib,
Sponsors
Sun Pharmaceutical Industries Limited
University Hospital, Lille
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of a local relapse at 2 years in both groups. | At 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of local relapse at 1 and 3 years. | at 1 year and at 3 years |
| Occurrence of adverse effects in the radiotherapy group. | at 1 year, at 2 years and at 3 years |
Countries
France
Contacts
Primary ContactLaurent Mortier, MD,PhD
Outcome results
None listed