Electrochemotherapy to shrink recurrent vulvar cancer before surgery
Use of Electrochemotherapy in Women With Vulvar Cancer
This trial will try electrochemotherapy — IV bleomycin plus brief electric pulses to the tumor — to shrink locally recurrent vulvar cancer in women who may otherwise need extensive surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 13 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institute of Oncology Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT07443475 on ClinicalTrials.gov |
What this trial studies
This prospective phase I/II study at the Institute of Oncology Ljubljana tests electrochemotherapy (ECT) as a neoadjuvant treatment for local recurrence of vulvar cancer. ECT uses an intravenous dose of bleomycin followed by delivery of electric pulses to the tumor and surrounding margin according to ESOPE procedures to increase drug uptake. Tumor response will be measured with RECIST, adverse events recorded by CTCAE v5.0, and quality of life tracked with EQ-5D and pain VAS; treated patients will be compared with a matched historical surgical control group. The trial plans to enroll 20 patients over five years with the goal of reducing the need for mutilating surgery and improving quality of life.
Who should consider this trial
Good fit: Women aged 18 or older with a local recurrence of vulvar cancer, life expectancy over three months, adequate performance status, fit for anesthesia, and able to provide informed consent are ideal candidates.
Not a fit: Patients with widespread metastatic disease, severe uncontrolled systemic illness, significantly impaired lung function, prior high cumulative bleomycin exposure, or pregnancy are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, ECT could shrink recurrent tumors enough to avoid extensive, mutilating surgery and improve patient quality of life.
How similar studies have performed: ECT has demonstrated good local control in cutaneous and some mucosal cancers with case reports/series in vulvar lesions, but its neoadjuvant use specifically to avoid radical vulvar surgery is less extensively studied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ljubljana
- Institute of Oncology Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Study coordinator: Sebastjan Merlo, MD
- Email: smerlo@onko-i.si
- Phone: +38615879490
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.