Status:
RECRUITING
Electrochemotherapy of Gynecological Cancers
Lead Sponsor:
Institute of Oncology Ljubljana
Conditions:
Gynecological Cancers
Eligibility:
FEMALE
18-105 years
Phase:
PHASE2
Brief 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 trea...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04760327
Start Date
July 1 2020
End Date
December 31 2025
Last Update
October 17 2024
Active Locations (1)
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1
Institute of oncology Ljubljna
Ljubljana, Slovenia, 1000