A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva.
Histologically confirmed newly diagnosed or recurrent (local) vulva SCC with or without distant metastases within 12 months
Tumor size ≤ 7 centimeters in the longest diameter.
Targeted lesion must be technically amenable for complete coverage (including margins) by the Alpha DaRT sources.
Measurable target according to RECIST v1.1
Concomitant chemotherapy or immunotherapy within the past 4 weeks
Fit for surgical exploration unless the patient refuses surgery
Known hypersensitivity to any of the components of the treatment.
Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
Single group
DaRT seeds
DeviceAn intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms
Feasibility - DaRT seed placement
Feasibility will be determined according to the rate of successful placement of Alpha DaRT
Safety - Adverse events
Safety will be determined according to the overall incidence of device related AEs and SAE's graded according to CTCAE v5.0 criteria.
Efficacy -Alpha DaRT seeds
The study's secondary objective will be to evaluate efficacy, as determined by local control evaluation according to RECIST v1.1
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