Vulvar CancerNCT05916690
Electrochemotherapy for the Treatment of Vulvar Cancer
A study testing Electrochemotherapy with bleomycin or cisplatin in people with Vulvar Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
Electrochemotherapy is a local treatment modality with effectiveness comparable to other local ablation techniques. With electrochemotherapy 80% objective response can be achieved and is suitable for the treatment of different types of tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vulvar Cancer
- What is being tested?
- Electrochemotherapy with bleomycin or cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Mar 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Local recurrence of vulvar cancer confirmed by histology
- The longest diameter of tumor 50 millimeters or less
- Age more than 18 years
- Life expectancy of more than 3 months
- Performance status according to Karnofsky ≥ 70 or < or 2 according to the WHO scale
- At least 2 weeks have passed since the last treatment
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- The patient must be able to understand the treatment process and possible side effects that may occur during the treatment
- Signed informed consent form
- The patient must be presented at a Multidisciplinary Tumor Board
Who cannot join
- Life-threatening infection and/or heart failure and/or liver failure and/or markedly impaired pulmonary function and/or other life-threatening systemic diseases
- Regional or distant metastases
- Age less than 18 years
- Major disturbances in the coagulation system (which do not respond to standard therapy - replacement of vitamin K or fresh frozen plasma)
- Exposure to cumulative bleomycin doses greater than 400 mg
- Impaired renal function (Creatinine > 150 µmol/L)
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- Epilepsy
- Pregnancy
- Patients who are unable to understand the treatment process or refuse to be involved in the treatment process
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
Institute of Oncology Ljubljana
Ljubljana
Maja Cemazar
About this study
Electrochemotherapy is a local treatment modality with effectiveness comparable to other local ablation techniques. With electrochemotherapy 80% objective response can be achieved and is suitable for the treatment of different types of tumors. The method is based on increased drug delivery to cells previously exposed to electroporation. The most commonly used cytotoxic agents are bleomycin and cisplatin. The aim of the proposed clinical trial is to determine the efficacy, feasibility and safety of electrochemotherapy in the treatment of vulvar cancer.
- Conditions
- Vulvar Cancer
- Being tested
- Electrochemotherapy with bleomycin or cisplatin
- 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 with bleomycin or cisplatinDrug
Combination of drug delivery platform (electroporation) and drug (bleomycin)
| Study group | Role | What they receive |
|---|---|---|
| Electrochemotherapy | Experimental | Not described Receives: Drug: Electrochemotherapy with bleomycin or cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events 1 month after the treatment
According to CTCAE v5.0
Measured: 1 month
Number of adverse events 2 months after the treatment
According to CTCAE v5.0
Measured: 2 months
Number of adverse events 3 months after the treatment
According to CTCAE v5.0
Measured: 3 months
Number of adverse events 6 months after the treatment
According to CTCAE v5.0
Measured: 6 months
Number of adverse events 9 months after the treatment
According to CTCAE v5.0
Measured: 9 months
Number of adverse events 12 months after the treatment
According to CTCAE v5.0
Measured: 12 months
Response of the tumor to electrochemotherapy according to RECIST criteria
According to RECIST criteria
Measured: 1 month
Response of the tumor to electrochemotherapy according to RECIST criteria
According to RECIST criteria
Measured: 2 months
Response of the tumor to electrochemotherapy according to RECIST criteria
According to RECIST criteria
Measured: 3 months
Response of the tumor to electrochemotherapy according to RECIST criteria
According to RECIST criteria
Measured: 6 months
Response of the tumor to electrochemotherapy according to RECIST criteria
According to RECIST criteria
Measured: 9 months
Response of the tumor to electrochemotherapy according to RECIST criteria
According to RECIST criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Mar 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT05916690
- Sponsor's protocol ID
- ERID-KSOPKR-0042/2021
- Status last verified
- Jan 2024
- First submitted
- 1 Jun 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrochemotherapy for the Treatment of Vulvar Cancer
- ClinicalTrials.gov ID
- NCT05916690
- Acronym / sponsor ID
- ERID-KSOPKR-0042/2021
- Conditions
- Vulvar Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jun 2023 (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.
Electrochemotherapy is a local treatment modality with effectiveness comparable to other local ablation techniques. With electrochemotherapy 80% objective response can be achieved and is suitable for the treatment of different types of tumors. The method is based on increased drug delivery to cells previously exposed to electroporation. The most commonly used cytotoxic agents are bleomycin and cisplatin. The aim of the proposed clinical trial is to determine the efficacy, feasibility and safety of electrochemotherapy in the treatment of vulvar cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrochemotherapy | Experimental | Drug: Electrochemotherapy with bleomycin or cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Local recurrence of vulvar cancer confirmed by histology
- The longest diameter of tumor 50 millimeters or less
- Age more than 18 years
- Life expectancy of more than 3 months
- Performance status according to Karnofsky ≥ 70 or < or 2 according to the WHO scale
Key exclusion criteria (9 listed)
- Life-threatening infection and/or heart failure and/or liver failure and/or markedly impaired pulmonary function and/or other life-threatening systemic diseases
- Regional or distant metastases
- Age less than 18 years
- Major disturbances in the coagulation system (which do not respond to standard therapy - replacement of vitamin K or fresh frozen plasma)
- Exposure to cumulative bleomycin doses greater than 400 mg
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 with bleomycin or cisplatinCombination of drug delivery platform (electroporation) and drug (bleomycin) | Drug | Electrochemotherapy |
Primary outcome
Number of adverse events 1 month after the treatment
Time frame: 1 month
According to CTCAE v5.0
Number of adverse events 2 months after the treatment
Time frame: 2 months
According to CTCAE v5.0
Number of adverse events 3 months after the treatment
Time frame: 3 months
According to CTCAE v5.0
Number of adverse events 6 months after the treatment
Time frame: 6 months
According to CTCAE v5.0
Number of adverse events 9 months after the treatment
Time frame: 9 months
According to CTCAE v5.0
Number of adverse events 12 months after the treatment
Time frame: 12 months
According to CTCAE v5.0
Response of the tumor to electrochemotherapy according to RECIST criteria
Time frame: 1 month
According to RECIST criteria
Response of the tumor to electrochemotherapy according to RECIST criteria
Time frame: 2 months
According to RECIST criteria
Response of the tumor to electrochemotherapy according to RECIST criteria
Time frame: 3 months
According to RECIST criteria
Response of the tumor to electrochemotherapy according to RECIST criteria
Time frame: 6 months
According to RECIST criteria
Response of the tumor to electrochemotherapy according to RECIST criteria
Time frame: 9 months
According to RECIST criteria
Response of the tumor to electrochemotherapy according to RECIST criteria
Time frame: 12 months
According to RECIST criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrochemotherapy with bleomycin or cisplatin in people with 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: status not confirmed, as of the sponsor's last update on 19 Jan 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maja Cemazar (+386-1-5879-544, mcemazar@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events 1 month after the treatment (time frame: 1 month). The study lists 12 primary outcomes in all. 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 19 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.