Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2020-07-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Electrochemotherapy of gynecological cancers
Electrochemotherapy with bleomycin or cisplatin
Electrochemotherapy with cisplatin or bleomycin of gynecological cancers
Interventions
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Electrochemotherapy with bleomycin or cisplatin
Electrochemotherapy with cisplatin or bleomycin of gynecological cancers
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age more than 18.
3. Life expectancy more than 3 month.
4. Performance status Karnofsky ≥ 70 or WHO \< or 2.
5. Treatment free interval minimum 2 weeks.
6. Patient must be mentally capable of understanding the given information and regarding treatment and any adverse reactions that may occur during treatment.
7. Patient must give informed consent.
8. Patient must be discussed at the multidisciplinary team before entering the trial.
9. Patient should be suitable for anesthesia.
Exclusion Criteria
2. Life-threatening infection and/or heart failure and/or liver failure and/or other severe systemic pathologies.
3. Significant reduction in respiratory function.
4. Age less than 18 years.
5. Coagulation disturbances (those who do not respond on standard treatment with vitamin-K or fresh frozen plasma).
6. Cumulative dose of ≥ 400 mg/m2 bleomycin received.
7. Impaired kidney function (creatinin \> 150 µmol/l).
8. Patients with epilepsy.
9. Pregnancy.
10. Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.
18 Years
105 Years
FEMALE
No
Sponsors
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Institute of Oncology Ljubljana
OTHER
Responsible Party
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Locations
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Institute of oncology Ljubljna
Ljubljana, , Slovenia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0120-692/2017/4
Identifier Type: -
Identifier Source: org_study_id
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