RecruitingPhase 2NCT07443475

Electrochemotherapy for Recurrent Vulvar Cancer

Use of Electrochemotherapy in Women With Vulvar Cancer

Sponsor

Institute of Oncology Ljubljana

Enrollment

13 participants

Start Date

Sep 1, 2021

Study Type

INTERVENTIONAL

Conditions

Vulvar Cancer Recurrent Vulvar Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a technique called electrochemotherapy — which combines a chemotherapy drug (bleomycin) with brief, strong electrical pulses to help the drug enter cancer cells more effectively — to treat recurrent vulvar cancer (cancer that has come back in the external female genital area after previous treatment). **You may be eligible if...** - You have a local recurrence of vulvar cancer (cancer has come back in the same area) - You are 18 or older - Your expected life expectancy is more than 3 months - You are in reasonable general health (Karnofsky status 70 or above, or WHO performance status 2 or lower) - At least 2 weeks have passed since your last treatment - You can understand the procedure and provide written consent - You have been reviewed by a multidisciplinary cancer team - You are fit for anesthesia **You may NOT be eligible if...** - You have a life-threatening infection or severe organ disease - Your lung function is significantly reduced (assessed by a specific breathing test) - You have had a high total lifetime dose of bleomycin (400 mg/m² or more) - You have significant kidney problems - You have epilepsy - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREElectrochemotherapy (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.