Gynecological CancersPhase 2GynECTNCT04760327
Electrochemotherapy of Gynecological Cancers
A Phase 2 study testing Electrochemotherapy with bleomycin or cisplatin in people with Gynecological Cancers, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
To determine the effectiveness, feasibility and safety of electrochemotherapy in treatment of local and/or regional recurrences of gynecological cancers with electrochemotherapy in which standard treatment options have been exhausted. Read more about this study
- Who is it for?
- Ages 18 to 105 years, women only
- Conditions the study is for
- Gynecological Cancers
- What is being tested?
- Electrochemotherapy with bleomycin or cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jul 2020to 31 Dec 2025
- 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 to 105 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Local or regional relapse of gynecological tumors in which standard treatment options have been exhausted.
- Age more than 18.
- Life expectancy more than 3 month.
- Performance status Karnofsky ≥ 70 or WHO < or 2.
- Treatment free interval minimum 2 weeks.
- Patient must be mentally capable of understanding the given information and regarding treatment and any adverse reactions that may occur during treatment.
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- Patient must give informed consent.
- Patient must be discussed at the multidisciplinary team before entering the trial.
- Patient should be suitable for anesthesia.
Who cannot join
- Visceral, bone or diffuse metastases.
- Life-threatening infection and/or heart failure and/or liver failure and/or other severe systemic pathologies.
- Significant reduction in respiratory function.
- Age less than 18 years.
- Coagulation disturbances (those who do not respond on standard treatment with vitamin-K or fresh frozen plasma).
- Cumulative dose of ≥ 400 mg/m2 bleomycin received.
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- Impaired kidney function (creatinin > 150 µmol/l).
- Patients with epilepsy.
- Pregnancy.
- Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.
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 Ljubljna
Ljubljana, 1000
Gregor Sersa, PhD, +386-1-5879-544, gsersa@onko-i.si
Maja Cemazar, PhD, mcemazar@onko-i.si
About this study
To determine the effectiveness, feasibility and safety of electrochemotherapy in treatment of local and/or regional recurrences of gynecological cancers with electrochemotherapy in which standard treatment options have been exhausted.
- Conditions
- Gynecological Cancers
- Being tested
- Electrochemotherapy with bleomycin or cisplatin
- Keywords
- Electrochemotherapy, Cisplatin, Bleomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrochemotherapy with bleomycin or cisplatinCombination product
Also called Combination of drug delivery platform (electroporation) and drug (bleomycin or cisplatin)
Electrochemotherapy with cisplatin or bleomycin of gynecological cancers
| Study group | Role | What they receive |
|---|---|---|
| Electrochemotherapy of gynecological cancers | Experimental | Not described Receives: Combination Product: Electrochemotherapy with bleomycin or cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of electrochemotherapy according to RECIST 1.1 criteria.
Effectiveness of electrochemotherapy in the treatment of local or regional recurrences of gynecological tumors in which standard treatment options have been exhausted. Effectiveness will be evaluated according to RECIST 1.1 criteria.
Measured: Changes from baseline regularly up to 24 months
Secondary outcomes (1)
Safety of electrochemotherapy according to CTCAE v5.0 criteria.
To determine safety of electrochemotherapy in the treatment of local or regional recurrences of gynecological tumors in which standard treatment options have been exhausted. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 criteria will be determined.
Measured: during hospitalization and up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Jul 2020
- Primary completion31 Dec 2025 (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 Gynecological CancersStudies 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
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT04760327
- Sponsor's protocol ID
- 0120-692/2017/4
- Acronym
- GynECT
- Status last verified
- Oct 2024
- First submitted
- 5 Apr 2018
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrochemotherapy of Gynecological Cancers
- ClinicalTrials.gov ID
- NCT04760327
- Acronym / sponsor ID
- GynECT / 0120-692/2017/4
- Conditions
- Gynecological Cancers
- Keywords
- Electrochemotherapy, Cisplatin, Bleomycin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Feb 2021 (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.
To determine the effectiveness, feasibility and safety of electrochemotherapy in treatment of local and/or regional recurrences of gynecological cancers with electrochemotherapy in which standard treatment options have been exhausted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrochemotherapy of gynecological cancers | Experimental | Combination Product: Electrochemotherapy with bleomycin or cisplatin |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Local or regional relapse of gynecological tumors in which standard treatment options have been exhausted.
- Age more than 18.
- Life expectancy more than 3 month.
- Performance status Karnofsky ≥ 70 or WHO < or 2.
- Treatment free interval minimum 2 weeks.
Key exclusion criteria (10 listed)
- Visceral, bone or diffuse metastases.
- Life-threatening infection and/or heart failure and/or liver failure and/or other severe systemic pathologies.
- Significant reduction in respiratory function.
- Age less than 18 years.
- Coagulation disturbances (those who do not respond on standard treatment with vitamin-K or fresh frozen plasma).
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 cisplatinAlso: Combination of drug delivery platform (electroporation) and drug (bleomycin or cisplatin)Electrochemotherapy with cisplatin or bleomycin of gynecological cancers | Combination product | Electrochemotherapy of gynecological cancers |
Primary outcome
Effectiveness of electrochemotherapy according to RECIST 1.1 criteria.
Time frame: Changes from baseline regularly up to 24 months
Effectiveness of electrochemotherapy in the treatment of local or regional recurrences of gynecological tumors in which standard treatment options have been exhausted. Effectiveness will be evaluated according to RECIST 1.1 criteria.
1 secondary outcome
Safety of electrochemotherapy according to CTCAE v5.0 criteria.
Time frame: during hospitalization and up to 24 months
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 17 Oct 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.
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 with bleomycin or cisplatin in people with Gynecological Cancers, 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 10 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 17 Oct 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.
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 Gregor Serša, PhD (+386 1 5879 434, gsersa@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of electrochemotherapy according to RECIST 1.1 criteria. (time frame: Changes from baseline regularly up to 24 months). 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 17 Oct 2024.