Electrochemotherapy for Recurrent Vulvar Cancer

Use of Electrochemotherapy in Women With Vulvar Cancer

This phase I/II interventional study evaluates the effectiveness and safety of electrochemotherapy (ECT) as neoadjuvant treatment for local recurrence of vulvar cancer. Electrochemotherapy combines intravenous administration of bleomycin with delivery of electric pulses to the tumor area, increasing drug uptake into cancer cells. The main goal is to assess tumor response and reduce the need for mutilating surgical procedures, thereby improving quality of life in women with recurrent vulvar cancer. Participants will be followed prospectively and treatment outcomes will be evaluated using RECIST criteria and adverse events using CTCAE v5.0.

Study Overview

• Status: Recruiting
• Conditions: Vulvar Cancer; Recurrent Vulvar Cancer
• Intervention / Treatment: Procedure: Electrochemotherapy (ECT)

Detailed Description

This is a prospective phase I/II institutional interventional clinical study conducted at the Institute of Oncology Ljubljana. The study investigates electrochemotherapy (ECT) as neoadjuvant treatment for women with local recurrence of vulvar cancer. ECT is performed according to ESOPE standard operating procedures, using systemic administration of bleomycin followed by delivery of electric pulses to the tumor and surrounding safety margin. Tumor response will be assessed clinically according to RECIST criteria, and adverse events will be recorded according to CTCAE version 5.0. Quality of life will be evaluated using EQ-5D questionnaire, pain VAS diary, and patient willingness to undergo ECT again. The ECT-treated group will be compared with a matched control group of patients previously treated surgically for recurrent vulvar cancer at the same institution. The planned study duration is 5 years (September 2021-August 2026), with planned enrollment of 20 patients aged 18 years or older.

• Study Type: Interventional
• Enrollment (Estimated): 13
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sebastjan Merlo, MD; Phone Number: +38615879490; Email: smerlo@onko-i.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • Institute of Oncology Ljubljana
    • Contact: Klavdija Korošec; Phone Number: +386 31630065; Email: kkorosec@onko-i.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Local recurrence of vulvar cancer
• Age ≥ 18 years
• Expected life expectancy > 3 months
• Karnofsky performance status ≥ 70 or WHO performance status ≤ 2
• At least 2 weeks since last treatment
• Ability to understand the procedure and possible adverse effects
• Ability to provide written informed consent
• Patient discussed at multidisciplinary tumor board before enrollment
• Fit for anesthesia

Exclusion Criteria:

• Life-threatening infection and/or severe cardiac, hepatic, or other systemic disease
• Significantly reduced lung function requiring DLCO testing (patients with abnormal DLCO are excluded)
• Age < 18 years
• Major coagulation disorders not responding to standard therapy
• Prior cumulative bleomycin dose ≥ 400 mg/m²
• Chronic renal impairment (creatinine > 150 µmol/L)
• Epilepsy
• Pregnancy
• Inability to understand the study or refusal to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Electrochemotherapy (ECT) Treatment Arm; Women with recurrent vulvar cancer receive electrochemotherapy using intravenous bleomycin followed by electric pulse delivery to tumor lesions according to ESOPE standard operating procedures. Tumor response is assessed using RECIST criteria and safety is monitored using CTCAE v5.0.

Procedure: Electrochemotherapy (ECT); Electrochemotherapy consists of intravenous bleomycin administration followed by delivery of electric pulses to the tumor area using appropriate electrodes, in accordance with ESOPE standard operating procedures. Electric pulses increase cell membrane permeability and enhance bleomycin uptake in tumor tissue.; Other Names: ECT; Bleomycin-based electrochemotherapy; ESOPE electrochemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Tumor Response Rate (RECIST)	Tumor response is assessed clinically using RECIST criteria and categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).	Up to 30 days after electrochemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (CTCAE v5.0)	Adverse events related to electrochemotherapy are recorded and graded according to CTCAE version 5.0. Serious adverse events are reported as required.	From treatment until 30 days after electrochemotherapy
Quality of Life (EQ-5D Questionnaire)	Quality of life is evaluated using EQ-5D questionnaire before treatment and during follow-up visits after electrochemotherapy. EQ-5D measures health-related quality of life (HRQoL) across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It calculates utility scores (where 1=perfect health, 0=death).	Baseline and during follow-up visits up to 5 years
Pain Intensity (VAS Diary)	Pain is assessed using a Visual Analogue Scale (VAS) diary during hospitalization and at follow-up visits.	From treatment through follow-up visits up to 30 days
Length of Hospital Stay	Length of hospitalization after electrochemotherapy is recorded.	During hospital stay

Collaborators and Investigators

• Sponsor: Institute of Oncology Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Electrochemotherapy; Bleomycin; Vulvar carcinoma
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Genital Neoplasms, Female; Vulvar Diseases; Vulvar Neoplasms; Investigative Techniques; Therapeutics; Clinical Laboratory Techniques; Drug Therapy; Cytological Techniques; Electrochemical Techniques; Electroporation Therapies; Electroporation; Electrochemotherapy
• Other Study ID Numbers: OI-EKT-VULVA-2021; ERID-KSOPR-0026/2023 (Other Identifier: Institute of Oncology Ljubljana (KSOPR))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No