Electrochemotherapy for Recurrent Vulvar Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrochemotherapy (ECT).
- Who it may be relevant to
- Registry conditions: Vulvar Cancer, Recurrent Vulvar Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of Electrochemotherapy in Women With Vulvar Cancer
Overview
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.
Detailed description
This is a prospective phase I/II institutional interventional clinical study conducted at the Institute of Oncology Ljubljana. The study investigates electrochemotherapy (ECT) as neoadjuvant treatment for women with local recurrence of vulvar cancer. ECT is performed according to ESOPE standard operating procedures, using systemic administration of bleomycin followed by delivery of electric pulses to the tumor and surrounding safety margin. Tumor response will be assessed clinically according to RECIST criteria, and adverse events will be recorded according to CTCAE version 5.0. Quality of life will be evaluated using EQ-5D questionnaire, pain VAS diary, and patient willingness to undergo ECT again. The ECT-treated group will be compared with a matched control group of patients previously treated surgically for recurrent vulvar cancer at the same institution. The planned study duration is 5 years (September 2021-August 2026), with planned enrollment of 20 patients aged 18 years or older.
Interventions
- Procedure Electrochemotherapy (ECT)
Electrochemotherapy 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.
Primary outcome measures
- Objective Tumor Response Rate (RECIST) [Time frame: Up to 30 days after electrochemotherapy]
Secondary outcome measures (4)
- Incidence of Adverse Events (CTCAE v5.0) [Time frame: From treatment until 30 days after electrochemotherapy]
- Quality of Life (EQ-5D Questionnaire) [Time frame: Baseline and during follow-up visits up to 5 years]
- Pain Intensity (VAS Diary) [Time frame: From treatment through follow-up visits up to 30 days]
- Length of Hospital Stay [Time frame: During hospital stay]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Slovenia · 1 center
- Institute of Oncology Ljubljana — Ljubljana
Identifiers
NCT: NCT07443475 · OI-EKT-VULVA-2021 · ERID-KSOPR-0026/2023