BLEOMYCIN for Vulvar intraepithelial neoplasia (VIN) grade 2-3 | Microinvasive vulvar carcinoma in situ | Vulvar Paget's disease (non-invasive)

Inclusion criteria

• {"criterion_text":"- Histological diagnosis of de novo or recurrent squamous disease of vulvar VIN 2-3, microinvasive carcinoma in situ of the vulva, and noninvasive vulvar Paget's disease\n- Positivity for cervical and/or vaginal HR HPV\n- Age > 18 years\n- Karnofsky performance status >70%\n- Informed consent to participate in the study\n- Absence of indication for surgical treatment due to extension of the disease, due to patient refusal, for anaesthesiological or reconstructive reasons\n- Negative Beta-hCG levels in urine (Pregnancy test or urinary beta-HCG) or blood (plasma beta-hCG)"}

Exclusion criteria

• {"criterion_text":"- Patients with histological diagnosis of adenocarcinoma\n- Patients with concomitant and/or previous tumours\n- Pregnancy in progress and breast feeding\n- Chronic renal failure\n- Chronic renal dysfunction\n- Patients with cardiac pacemakers\n- Epilepsy\n- Pulmonary pathologies with medium/severe respiratory insufficiency\n- Poor or abnormal lung function\n- Significant coagulation disorders\n- Coagulation disorders (platelets < 70,000/mm3 and INR>1.5)\n- HPV vaccination in progress\n- Patients with immunosuppressive diseases or treatments (HIV positive)\n- Bleomycin and/or Cisplatin allergy\n- Cumulative doses of 250mg/sqm of Bleomycin received"}

Primary endpoints

• {"endpoint_text":"- Evaluation of histological pathological response of vulvar lesions and non-invasive Paget's disease on surgical specimens 30 days after electrochemotherapy according to RECIST criteria","definition_or_measurement_approach":"Histological pathological response assessed on surgical specimens 30 days after electrochemotherapy using RECIST criteria."}

Secondary endpoints

• {"endpoint_text":"- Safety of the method evaluated using the CTCAE criteria v. 5.0\n- Assessment of HPV persistence by HPV test at the 6-month visit\n- Duration of disease control in follow-up\n- Symptomatology assessment using specific questionnaires (VAS, EQ-5D, FSFI) filled in by patients before treatment and one, three, six and twelve months after treatment","definition_or_measurement_approach":"Safety assessed by CTCAE v5.0; HPV persistence assessed by HPV test at 6 months; duration of disease control measured during follow-up; symptomatology assessed via VAS, EQ-5D and FSFI questionnaires at baseline and 1, 3, 6 and 12 months after treatment."}

Italy

Earliest CTIS Part Ii Submission Date

07-10-2024

Latest Decision Or Authorization Date

25-11-2024

Processing Time Days

49

Number Of Sites

1

Number Of Participants

18

Primary sponsor

Full Name

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy