Vulvar CancerPhase 2NCT07443475
Electrochemotherapy for Recurrent Vulvar Cancer
A Phase 2 study testing Electrochemotherapy (ECT) in people with Vulvar Cancer and Recurrent Vulvar Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Cancer, Recurrent Vulvar Cancer
- What is being tested?
- Electrochemotherapy (ECT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Sep 2021to 31 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Ability to provide written informed consent
- Patient discussed at multidisciplinary tumor board before enrollment
- Fit for anesthesia
Who cannot join
- 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)
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- Epilepsy
- Pregnancy
- Inability to understand the study or refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
Institute of Oncology Ljubljana
Ljubljana, 1000
Klavdija Korošec, +386 31630065, kkorosec@onko-i.si
About this study
Official title: Use of Electrochemotherapy in Women With Vulvar Cancer
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.
Read the detailed description
This is a prospective phase I/II institutional interventional clinical study conducted at the Institute of Oncology Ljubljana. The study investigates electrochemotherapy (ECT) as neoadjuvant treatment for women with local recurrence of vulvar cancer. ECT is performed according to ESOPE standard operating procedures, using systemic administration of bleomycin followed by delivery of electric pulses to the tumor and surrounding safety margin. Tumor response will be assessed clinically according to RECIST criteria, and adverse events will be recorded according to CTCAE version 5.0. Quality of life will be evaluated using EQ-5D questionnaire, pain VAS diary, and patient willingness to undergo ECT again. The ECT-treated group will be compared with a matched control group of patients previously treated surgically for recurrent vulvar cancer at the same institution. The planned study duration is 5 years (September 2021-August 2026), with planned enrollment of 20 patients aged 18 years or older.
- Conditions
- Vulvar Cancer, Recurrent Vulvar Cancer
- Being tested
- Electrochemotherapy (ECT)
- Keywords
- Electrochemotherapy, Bleomycin, Vulvar carcinoma
- Medical subject headings
- Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrochemotherapy (ECT)Procedure or surgery
Also called ECT, Bleomycin-based electrochemotherapy, ESOPE electrochemotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Electrochemotherapy (ECT) Treatment Arm | Experimental | 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. Receives: Procedure: Electrochemotherapy (ECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Tumor Response Rate (RECIST)
Tumor response is assessed clinically using RECIST criteria and categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
Measured: Up to 30 days after electrochemotherapy
Secondary outcomes (4)
Incidence of Adverse Events (CTCAE v5.0)
Adverse events related to electrochemotherapy are recorded and graded according to CTCAE version 5.0. Serious adverse events are reported as required.
Measured: From treatment until 30 days after electrochemotherapy
Quality of Life (EQ-5D Questionnaire)
Quality of life is evaluated using EQ-5D questionnaire before treatment and during follow-up visits after electrochemotherapy. EQ-5D measures health-related quality of life (HRQoL) across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It calculates utility scores (where 1=perfect health, 0=death).
Measured: Baseline and during follow-up visits up to 5 years
Pain Intensity (VAS Diary)
Pain is assessed using a Visual Analogue Scale (VAS) diary during hospitalization and at follow-up visits.
Measured: From treatment through follow-up visits up to 30 days
Length of Hospital Stay
Length of hospitalization after electrochemotherapy is recorded.
Measured: During hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Sep 2021
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm study of electrochemotherapy (bleomycin + electric pulses) with comparison to matched historical controls treated surgically.
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443475
- Sponsor's protocol ID
- OI-EKT-VULVA-2021
- Other IDs
- ERID-KSOPR-0026/2023
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Electrochemotherapy in Women With Vulvar Cancer
- ClinicalTrials.gov ID
- NCT07443475
- Acronym / sponsor ID
- OI-EKT-VULVA-2021
- Conditions
- Vulvar Cancer, Recurrent Vulvar Cancer
- Keywords
- Electrochemotherapy, Bleomycin, Vulvar carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective phase I/II institutional interventional clinical study conducted at the Institute of Oncology Ljubljana. The study investigates electrochemotherapy (ECT) as neoadjuvant treatment for women with local recurrence of vulvar cancer. ECT is performed according to ESOPE standard operating procedures, using systemic administration of bleomycin followed by delivery of electric pulses to the tumor and surrounding safety margin. Tumor response will be assessed clinically according to RECIST criteria, and adverse events will be recorded according to CTCAE version 5.0. Quality of life will be evaluated using EQ-5D questionnaire, pain VAS diary, and patient willingness to undergo ECT again. The ECT-treated group will be compared with a matched control group of patients previously treated surgically for recurrent vulvar cancer at the same institution. The planned study duration is 5 years (September 2021-August 2026), with planned enrollment of 20 patients aged 18 years or older.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm study of electrochemotherapy (bleomycin + electric pulses) with comparison to matched historical controls treated surgically.
| Arm | Type | Receives |
|---|---|---|
| Electrochemotherapy (ECT) Treatment Arm | Experimental | Procedure: Electrochemotherapy (ECT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrochemotherapy (ECT)Also: ECT, Bleomycin-based electrochemotherapy, ESOPE electrochemotherapyElectrochemotherapy 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. | Procedure or surgery | Electrochemotherapy (ECT) Treatment Arm |
Primary outcome
Objective Tumor Response Rate (RECIST)
Time frame: Up to 30 days after electrochemotherapy
Tumor response is assessed clinically using RECIST criteria and categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
4 secondary outcomes
Incidence of Adverse Events (CTCAE v5.0)
Time frame: From treatment until 30 days after electrochemotherapy
Quality of Life (EQ-5D Questionnaire)
Time frame: Baseline and during follow-up visits up to 5 years
Pain Intensity (VAS Diary)
Time frame: From treatment through follow-up visits up to 30 days
Length of Hospital Stay
Time frame: During hospital stay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Electrochemotherapy (ECT) in people with Vulvar Cancer and Recurrent Vulvar Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastjan Merlo, MD (+38615879490, smerlo@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Tumor Response Rate (RECIST) (time frame: Up to 30 days after electrochemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.