Carcinoma of the Vulva Clinical Trial
Official title:
A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva
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.
This is an prospective Open label, single arm, multi center, interventional study treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva .The study objectives are to collect data on the Feasibility and Safety of DaRT among patients who do not fit the entry of existing investigational trials. The primary endpoint of the study is to evaluate the feasibility and safety of the Alpha DaRT sources for the treatment of vulva SCC. Feasibility will be determined according to the rate of successful placement of Alpha DaRT . Safety will be determined according to the overall incidence of device related AEs and SAE's graded according to CTCAE v5.0 criteria. The Secondary endpoint of the study will be to evaluate efficacy, as determined by local control evaluation according to RECIST v1.1 ;
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