Electrochemotherapy for 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

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Conditions3

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