A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters for the Treatment of Vulva Cancer

Inclusion Criteria: * Newly diagnosed or recurrent (local) vulva cancer with or without distant metastases * Histopathological confirmation of squamous cell carcinoma * Macroscopic tumour in situ (i.e. tumour not excised) * Age 18 years and over * ECOG performance status 0-2 * Life expectancy more than 6 months * Willing and able to give written informed consent to participate * Measurable target according to RECIST v1.1 * Tumour size ≤ 7 centimetres in the longest diameter * Target is technically amenable for full coverage by the DaRT seeds Exclusion Criteria: * Non-squamous histology * Concomitant illnesses which may increase risk of radiation toxicity e.g. autoimmune diseases, vasculitis, etc. * Concomitant immunosuppressive and/or long-term corticosteroid treatment * Involvement in other studies that may affect evaluation of response or toxicity of DaRT in the past 30 days or 5 half-lives of the investigational product, whichever is longer * Pregnancy or breastfeeding * Women of child-bearing potential unwilling to use adequate contraception for the duration of the study and 6 months after completion (further details in CIP section 13) * Nodal recurrence without local recurrence * Previous diagnosis of other malignancy \< 3 years of enrolment (excluding non-melanomatous skin cancer) * No concurrent chemotherapy * Patients who have received prior chemotherapy or targeted therapy require a 1-month washout before DaRT insertion * Requirement to start chemotherapy within 6…