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Electrochemotherapy for Recurrent Vulvar Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 2, 2026 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07443475
Lead Sponsor Institute of Oncology Ljubljana
Conditions Vulvar Cancer, Recurrent Vulvar Cancer
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov