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Electric pulses + chemo: new hope for vulvar cancer?

NCT ID NCT07443475

Disease control Sponsor: Institute of Oncology Ljubljana Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a treatment called electrochemotherapy for women whose vulvar cancer has come back. It combines a chemotherapy drug (bleomycin) with electric pulses to help the drug enter cancer cells more effectively. The goal is to shrink tumors and avoid major surgery. Only 13 participants will be enrolled in this early-phase trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bleomycin
What this could lead to
If successful, this approach could shrink vulvar cancer tumors and reduce the need for disfiguring surgery, improving quality of life.
What could go wrong
This is a very small early-phase trial (13 people) with no control group, so results may not apply broadly. Side effects from bleomycin or the electric pulses are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 13 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

vulva cancer vulvar carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Recurrent vulvar cancer Vulvar cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institute of Oncology Ljubljana

    RECRUITING

    Ljubljana, 1000, Slovenia

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