Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT07443475

Electrochemotherapy for Recurrent Vulvar Cancer

Led by Institute of Oncology Ljubljana · Updated on 2026-03-02

13

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Electrochemotherapy for Recurrent Vulvar Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Local recurrence of vulvar cancer
  • Age 18 years or older
  • Expected life expectancy greater than 3 months
  • Karnofsky performance status 70 or higher or WHO performance status 2 or lower
  • 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
Not Eligible

You will not qualify if you...

  • Life-threatening infection or severe cardiac, liver, or other systemic disease
  • Significantly reduced lung function requiring DLCO testing (excluded if abnormal DLCO)
  • Age under 18 years
  • Major coagulation disorders not responsive to standard therapy
  • Prior cumulative bleomycin dose 400 mg/m² or more
  • Chronic kidney impairment (creatinine above 150 µmol/L)
  • Epilepsy
  • Pregnancy
  • Inability to understand the study or refusal to participate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institute of Oncology Ljubljana

Ljubljana, Slovenia, 1000

Actively Recruiting

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Research Team

S

Sebastjan Merlo, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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