Actively Recruiting
Use of Electrochemotherapy in Women With Vulvar Cancer
Led by Institute of Oncology Ljubljana · Updated on 2026-03-02
13
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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 I/II 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 30 days after electrochemotherapy
Participants receive electrochemotherapy consisting of intravenous bleomycin followed by delivery of electric pulses to the tumor area according to ESOPE standard operating procedures.
1 hospital stay including treatment and monitoring
Duration - Up to 5 years
Participants are monitored for tumor response, adverse events, quality of life, and pain intensity after treatment.
Follow-up visits for assessments including quality of life questionnaires and pain diaries
Trial Site Locations
Total: 1 location
1
Institute of Oncology Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
Research Team
S
Sebastjan Merlo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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