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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Electrochemotherapy (ECT)
Procedure/SurgeryElectrochemotherapy consists of intravenous bleomycin administration followed by delivery of electric pulses to the tumor area using appropriate electrodes, in accordance with ESOPE standard operating procedures. Electric pulses increase cell membrane permeability and enhance bleomycin uptake in tumor tissue.
Treatment groups
13 Participants
are divided into 1 treatment groupGroup A: Electrochemotherapy (ECT) Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Tumor Response Rate (RECIST)
Tumor response is assessed clinically using RECIST criteria and categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
Time frame
Up to 30 days after electrochemotherapySecondary outcomes
1
Incidence of Adverse Events (CTCAE v5.0)
Adverse events related to electrochemotherapy are recorded and graded according to CTCAE version 5.0. Serious adverse events are reported as required.
Time frame
From treatment until 30 days after electrochemotherapy2
Quality of Life (EQ-5D Questionnaire)
Quality of life is evaluated using EQ-5D questionnaire before treatment and during follow-up visits after electrochemotherapy. EQ-5D measures health-related quality of life (HRQoL) across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It calculates utility scores (where 1=perfect health, 0=death).
Time frame
Baseline and during follow-up visits up to 5 years3
Pain Intensity (VAS Diary)
Pain is assessed using a Visual Analogue Scale (VAS) diary during hospitalization and at follow-up visits.
Time frame
From treatment through follow-up visits up to 30 days4
Length of Hospital Stay
Length of hospitalization after electrochemotherapy is recorded.
Time frame
During hospital staySponsors and contacts
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Source ClinicalTrials.gov