Single-center phase II study on the use of electrochemotherapy in the treatment of Paget's disease and high-grade or initially invasive precancerous squamous lesions of the vulva (GinOnc-ECT study)

Phase 1

• Conditions: patients with newly diagnosed or recurrent high-grade or initially invasive precancerous squamous lesions of the vulva and non-invasive vulvar Paget's disease; MedDRA version: 20.0Level: LLTClassification code 10051963Term: Vulvar carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10033369Term: Paget's disease of the vulvaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2023-000128-12-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-06
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

• 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
• Positivity for cervical and/or vaginal HR HPV
• Age > 18 years
• Karnofsky performance status >70%
• Informed consent to participate in the study
• Absence of indication for surgical treatment due to extension of the disease, due to patient refusal, for anaesthesiological or reconstructive reasons.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion Criteria

• Patients with histological diagnosis of adenocarcinoma
• Patients with concomitant and/or previous tumours
• Pregnancy in progress
• Chronic renal failure
• Patients with cardiac pacemakers
• Epilepsy
• Pulmonary pathologies with medium/severe respiratory insufficiency
• Coagulation disorders (platelets < 70,000/mm3 and INR>1.5)
• HPV vaccination in progress
• Patients with immunosuppressive diseases or treatments (HIV positive)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the activity of electrochemotherapy in the treatment of vulvar lesions and non-invasive Paget's disease;Secondary Objective: • Evaluation of the safety of electrochemotherapy<br>• Evaluation of the control of the presence of HPV<br>• Follow-up evaluation of vulvar VIN 2-3 and non-invasive Paget's disease<br>• Evaluation of the symptoms reported by the patient;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: 30 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety of the method evaluated using the CTCAE criteria v. 5.0; Assessment of HPV persistence by HPV test at the 6-month visit; Duration of disease control in follow-up; Symptomatology assessment using specific questionnaires (VAS, EQ-5D, FSFI) filled in by patients before treatment and one, three, six and twelve months after treatment;Timepoint(s) of evaluation of this end point: 30 days; 6 months; 2 anni; 12 months