Electrochemotherapy for Recurrent Vulvar Cancer
Recruiting now · Phase 2
Conditions studied: Vulvar Cancer, Recurrent Vulvar Cancer
In brief
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.
Key facts
- Study ID
- NCT07443475
- Run by
- Institute of Oncology Ljubljana
- People needed
- 13
- Starts
- 2021-09-01
- Expected to finish
- 2026-08-31
- Last updated by the study team
- 2026-03-02
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Local recurrence of vulvar cancer
- Age ≥ 18 years
- Expected life expectancy > 3 months
- Karnofsky performance status ≥ 70 or WHO performance status ≤ 2
- 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 may not qualify if…
- Life-threatening infection and/or severe cardiac, hepatic, or other systemic disease
- Significantly reduced lung function requiring DLCO testing (patients with abnormal DLCO are excluded)
- Age < 18 years
- Major coagulation disorders not responding to standard therapy
- Prior cumulative bleomycin dose ≥ 400 mg/m²
- Chronic renal impairment (creatinine > 150 µmol/L)
- Epilepsy
- Pregnancy
- Inability to understand the study or refusal to participate
Where it is running
- Institute of Oncology Ljubljana — Ljubljana, Slovenia (enrolling)
Full record on ClinicalTrials.gov
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