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Trial Title:
Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma
NCT ID:
NCT05561634
Condition:
Basal Cell Carcinoma
Radiotherapy; Complications
Conditions: Official terms:
Carcinoma
Carcinoma, Basal Cell
Conditions: Keywords:
Locally advanced basal cell carcinoma
Sonic Hedgehog inhibitors
Consideration radiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
Irradiation of the tumoral bed.
Arm group label:
SHHI then follow-up
Arm group label:
SHHI then radiotherapy
Intervention type:
Other
Intervention name:
Observation
Description:
Patients will be followed up in consultation every 3 months.
Arm group label:
SHHI then follow-up
Intervention type:
Drug
Intervention name:
Vismodegib
Description:
Sonic Hedgehog inhibitors (SHHi) = Vismodegib et Sonidegib,
Arm group label:
SHHI then radiotherapy
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
July 2023
Completion date:
July 2028
Lead sponsor:
Agency:
University Hospital, Lille
Agency class:
Other
Collaborator:
Agency:
Sun Pharmaceutical Industries Limited
Agency class:
Industry
Source:
University Hospital, Lille
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05561634
