RecruitingPhase 2NCT07443475

Electrochemotherapy for Recurrent Vulvar Cancer

Use of Electrochemotherapy in Women With Vulvar Cancer

Sponsor

Institute of Oncology Ljubljana

Enrollment

13 participants

Start Date

Sep 1, 2021

Study Type

INTERVENTIONAL

Conditions

Vulvar Cancer Recurrent Vulvar Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria9

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 Criteria9

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

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.