Electrochemotherapy for Recurrent Vulvar Cancer
Recruiting
Phase 2
Interventional Study
Vulvar Cancer
Recurrent Vulvar Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 13 (estimated)
- Sponsor
- Institute of Oncology Ljubljana · Other
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About This Trial
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 mu…
Trial Locations
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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 p…
Contacts