Electrochemotherapy of Gynecological Cancers

Recruiting now · Phase 2

Conditions studied: Gynecological Cancers

In brief

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.

Key facts

Study ID

NCT04760327

Run by

Institute of Oncology Ljubljana

People needed

30

Starts

2020-07-01

Expected to finish

2025-12-31

Last updated by the study team

2024-10-17

Who can join

Age: 18 and older, up to 105. Sex: female. Healthy volunteers: not accepted.

You may qualify 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.
• 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.

You may not qualify 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.
• 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.

Where it is running

• Institute of oncology Ljubljna — Ljubljana, Slovenia (enrolling)

Full record on ClinicalTrials.gov

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