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Electrochemotherapy for Recurrent Vulvar Cancer
Sponsor: Institute of Oncology Ljubljana
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.
Official title: Use of Electrochemotherapy in Women With Vulvar Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
13
Start Date
2021-09-01
Completion Date
2026-08-31
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Institute of Oncology Ljubljana
Ljubljana, Slovenia