Electrochemotherapy for Recurrent Vulvar Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstitute of Oncology Ljubljana
About this trial
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 criteria
Qualifiers
Local recurrence of vulvar cancer
Age ≥ 18 years
Expected life expectancy > 3 months
Karnofsky performance status ≥ 70 or WHO performance status ≤ 2
Disqualifiers
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
Trial design
Treatments tested in this trial
- Electrochemotherapy (ECT)
Treatment groups
13 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov