RecruitingPhase 2NCT04760327

Electrochemotherapy of Gynecological Cancers


Sponsor

Institute of Oncology Ljubljana

Enrollment

30 participants

Start Date

Jul 1, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 105 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment called electrochemotherapy (ECT) for women with gynecological cancers (such as cervical, ovarian, or uterine cancers) that have come back locally after other treatments have stopped working. Electrochemotherapy combines a cancer-fighting drug (bleomycin) with brief electrical pulses delivered directly to the tumor. The electrical pulses temporarily open up cancer cell walls, allowing more of the drug to get inside and destroy the cancer cells. It is done under anesthesia. The goal is to see whether this technique can help control local or regional tumors in women who have run out of standard treatment options. Participants must be in reasonably good health overall, with a life expectancy of at least 3 months and no major organ failure. You may be eligible if... - You are a woman aged 18 or older - You have a gynecological tumor that has come back locally or regionally - Standard treatment options have been exhausted - Your performance status is acceptable (Karnofsky ≥70 or WHO <2) - Your life expectancy is more than 3 months - You are suitable for anesthesia - You have been free of cancer treatment for at least 2 weeks You may NOT be eligible if... - Cancer has spread to internal organs, bones, or widely throughout the body - You have a life-threatening infection, or heart, liver, or other severe organ failure - You have significant breathing problems - You have serious blood clotting disorders - You have received a cumulative bleomycin dose of 400 mg/m² or more - You have impaired kidney function - You have epilepsy - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTElectrochemotherapy with bleomycin or cisplatin

Electrochemotherapy with cisplatin or bleomycin of gynecological cancers


Locations(1)

Institute of oncology Ljubljna

Ljubljana, Slovenia

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NCT04760327


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