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)

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) - GinOnc-ECT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2023-000128-12-IT

Enrollment

Registered

2023-02-06

Start date

2023-04-20

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 20.0 Level: LLT Classification code 10051963 Term: Vulvar carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10033369 Term: Paget's disease of the vulva System Organ Class: 10029104 - Neoplasms benign, malignant an

Interventions

Product Name: cisplatino Product Code: NA Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: cisplatino Current Sponsor code: NA Concentration unit: mg/ml millig

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 1.5) • HPV vaccination in progress • Patients with immunosuppressive diseases or treatments (HIV positive)

Design outcomes

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Primary

Measure	Time frame
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 • Evaluation of the control of the presence of HPV • Follow-up evaluation of vulvar VIN 2-3 and non-invasive Paget's disease • 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	—

Measure

Time frame

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 • Evaluation of the control of the presence of HPV • Follow-up evaluation of vulvar VIN 2-3 and non-invasive Paget's disease • 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

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Countries

Italy

Contacts

Public ContactDirezione Scientifica

Fondazione Policlinico Universitario A. Gemelli IRCCS

direzione.scientifica@policlinicogemelli.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026