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โ† Trials
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Electrochemotherapy for Recurrent Vulvar Cancer

RecruitingPhase 2Ages 18 Years - anyFemaleInstitute of Oncology Ljubljana
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Local recurrence of vulvar cancer * Age โ‰ฅ 18 years * Expected life expectancy \> 3 months * Karnofsky performance status โ‰ฅ 70 or WHO performance status โ‰ค 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 โ‰ฅ 400 mg/mยฒ * Chronic renal impairment (creatinine \> 150 ยตmol/L) * Epilepsy * Pregnancy * Inability to understand the study or refusal to participate
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What it tests

  • Electrochemotherapy (ECT)
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Where

1 site
Institute of Oncology Ljubljana
Ljubljana, Slovenia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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