Clinical trial · Interventional
Electrochemotherapy for Recurrent Vulvar Cancer
Use of Electrochemotherapy in Women With Vulvar Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_BROADER | 0.78 |
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electrochemotherapy (ECT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Electrochemotherapy (ECT) Treatment Arm
- description
- Women with recurrent vulvar cancer receive electrochemotherapy using intravenous bleomycin followed by electric pulse delivery to tumor lesions according to ESOPE standard operating procedures. Tumor response is assessed using RECIST criteria and safety is monitored using CTCAE v5.0.
- interventionNames
- Procedure: Electrochemotherapy (ECT)
Primary outcomes (1)
- measure
- Objective Tumor Response Rate (RECIST)
- timeFrame
- Up to 30 days after electrochemotherapy
- description
- 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 outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available