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New treatment option for Gynecological Cancers
Official title Electrochemotherapy of Gynecological Cancers
ClinicalTrials.gov ID: NCT04760327
What this study is testing
What is Electrochemotherapy with bleomycin or cisplatin?
Electrochemotherapy with bleomycin or cisplatin is an investigational medicine, being studied as a potential treatment for gynecological cancers.
Also referred to as Combination of drug delivery platform (electroporation) and drug (bleomycin or cisplatin).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 105, women only
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- Patient must give informed consent.
- Patient must be discussed at the multidisciplinary team before entering the trial.
- Patient should be suitable for anesthesia.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ljubljana, Slovenia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 105 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ljubljana, Slovenia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.