Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer

Inclusion Criteria:

• Age ≥ 18 years old
• Recurrent VC confirmed by histological examination
• Patient who underwent multiple treatments (surgery and radiation therapy orchemoradiation, radiation therapy or chemoradiation and chemotherapy).
• Patient not eligible for standard therapies (surgery, radiation therapy and systemicchemotherapy in case of metastatic disease) due to the performance status (ECOGPerformance Status ≥ 3 )
• Life expectancy more than three months
• Measurable disease according to RECIST 1.1
• Adequate bone marrow, liver, and kidney function (creatinine <1.5 mg/dl), andcoagulation parameters as follows:
• Bone marrow (Hemoglobin ≥ 8.0 g/dL with or without transfusion support, Plateletcount ≥ 75 × 109/L?) o INR >1.5;
• Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT),alanine aminotransferase (ALT)/serum glutamic-pyruvate transaminase (SGPT) ≤3.0 ×upper limit of normal (ULN)
• Total bilirubin ≤2.0 × ULN or ≤3 × ULN except for subjects with Gilbert'ssyndrome
• Serum creatinine <1.5 mg/dl and creatinine clearance > 30 ml/min All bloodassessments must be performed within 15 days from ECT treatment.
• For females of childbearing potential, a negative serum pregnancy human chorionicgonadotropin (hCG) pregnancy test within 72 hours of study Day 1.
• Signed informed consent obtained prior to initiation of any study-specific proceduresand treatment as confirmation of the patient's awareness and willingness to comply thestudy requirements.

Exclusion Criteria:

• History of other malignancies in the previous five years, except basal cell carcinomaof the skin.
• History of psychological, familial, sociological, or geographical conditionpotentially preventing compliance with the study protocol and follow-up schedule.
• Allergic reactions to the two chemotherapy drugs (BLM and AUC2-CARBOPLATIN) and/ortheir excipients.
• Evidence of pulmonary fibrosis.