Recurrent Vulvar Cancer, Vulvar Cancer
Conditions
Keywords
Electrochemotherapy, Bleomycin, Vulvar carcinoma
Brief 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.
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
PROCEDUREElectrochemotherapy (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.
Sponsors
Institute of Oncology Ljubljana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm study of electrochemotherapy (bleomycin + electric pulses) with comparison to matched historical controls treated surgically.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Tumor Response Rate (RECIST) | Up to 30 days after electrochemotherapy | Tumor response is assessed clinically using RECIST criteria and categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (CTCAE v5.0) | From treatment until 30 days after electrochemotherapy | Adverse events related to electrochemotherapy are recorded and graded according to CTCAE version 5.0. Serious adverse events are reported as required. |
| Quality of Life (EQ-5D Questionnaire) | Baseline and during follow-up visits up to 5 years | 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). |
| Pain Intensity (VAS Diary) | From treatment through follow-up visits up to 30 days | Pain is assessed using a Visual Analogue Scale (VAS) diary during hospitalization and at follow-up visits. |
| Length of Hospital Stay | During hospital stay | Length of hospitalization after electrochemotherapy is recorded. |
Countries
Slovenia
Contacts
CONTACTSebastjan Merlo, MD
Outcome results
None listed