What is electrochemotherapy studying for recurrent vulvar cancer?

Electrochemotherapy is being studied as a neoadjuvant treatment for women with local recurrence of vulvar cancer. Researchers aim to assess tumor response and reduce the need for extensive surgery, improving quality of life. The study is sponsored by the Institute of Oncology Ljubljana and follows strict procedures to evaluate safety and effectiveness.

Who may be eligible for this vulvar cancer clinical trial?

Women aged 18 years or older with local recurrence of vulvar cancer may be eligible. Participants should have a life expectancy greater than three months, be fit for anesthesia, and able to understand and consent to the procedure. Please review eligibility criteria for more details.

Is there any cost to participate in this vulvar cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly based on their individual circumstances.

Actively Recruiting

Phase 2

Age: 18Years +

FEMALE

ID07443475

Use of Electrochemotherapy in Women With Vulvar Cancer

Led by Institute of Oncology Ljubljana · Updated on 2026-03-02

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating electrochemotherapy ECT as a neoadjuvant treatment for women with local recurrence of vulvar cancer in this phase III interventional study. ECT combines intravenous bleomycin with electric pulses to increase drug uptake into tumor cells. The study aims to assess tumor response, reduce the need for disfiguring surgery, and improve quality of life. Treatment outcomes will be assessed using RECIST criteria while adverse events will be recorded with CTCAE version 5.0. Participants receive ECT following ESOPE standard operating procedures, involving intravenous bleomycin administration followed by electric pulses delivered to the tumor area and surrounding safety margin. The study compares outcomes of ECT-treated patients with a matched control group previously treated surgically. The planned duration of the study is five years, enrolling about 20 women aged 18 or older. During the study, participants will be monitored for tumor response, adverse events, pain levels using a visual analog scale diary, and quality of life via the EQ-5D questionnaire. Follow-up visits will continue up to five years to collect data on these measures, including length of hospital stay. Safety and treatment effects will be carefully tracked from treatment until 30 days after ECT, with ongoing quality of life assessments during the follow-up period.

CONDITIONS

Brief Title

Electrochemotherapy for Recurrent Vulvar Cancer

Who Can Participate

Age: 18Years +

FEMALE

Eligibility Criteria

You may qualify if you...

Local recurrence of vulvar cancer
Age 18 years or older
Expected life expectancy greater than 3 months
Karnofsky performance status of 70 or higher or WHO performance status of 2 or less
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 will not qualify if you...

Life-threatening infection or severe cardiac, hepatic, or other systemic disease
Significantly reduced lung function requiring DLCO testing
Age under 18 years
Major coagulation disorders not responding to standard therapy
Prior cumulative bleomycin dose of 400 mg/m² or more
Chronic renal impairment with creatinine over 150 µmol/L
Epilepsy
Pregnancy
Inability to understand the study or refusal to participate

Research Team

Sebastjan Merlo, MD

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