Electrochemotherapy for Recurrent Vulvar Cancer

NCT07443475 | Recruiting Phase 2

• 2 other identifiers: OI-EKT-VULVA-2021ERID-KSOPR-0026/2023
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vulvar Cancer; Recurrent Vulvar Cancer

Keywords

Electrochemotherapy; Bleomycin; Vulvar carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of Adverse Events (CTCAE v5.0)

  From treatment until 30 days after electrochemotherapy

• Quality of Life (EQ-5D Questionnaire)

  Baseline and during follow-up visits up to 5 years

• Pain Intensity (VAS Diary)

  From treatment through follow-up visits up to 30 days

• Length of Hospital Stay

  During hospital stay

Study Arms (1)

Electrochemotherapy (ECT) Treatment Arm

EXPERIMENTAL

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)

Interventions

Electrochemotherapy (ECT) PROCEDURE

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.

Also known as: ECT, Bleomycin-based electrochemotherapy, ESOPE electrochemotherapy

Electrochemotherapy (ECT) Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Vulvar Neoplasms

Interventions

Electrochemotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Electroporation Therapies; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Central Study Contacts

Sebastjan Merlo, MD

CONTACT

+38615879490; smerlo@onko-i.si

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm study of electrochemotherapy (bleomycin + electric pulses) with comparison to matched historical controls treated surgically.

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: March 2, 2026
• Study Start: September 1, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)