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Recruiting Phase 2 NCT04760327

Electrochemotherapy of Gynecological Cancers

Trial Parameters

Condition Gynecological Cancers
Sponsor Institute of Oncology Ljubljana
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 30
Sex FEMALE
Min Age 18 Years
Max Age 105 Years
Start Date 2020-07-01
Completion 2025-12-31
Interventions
Electrochemotherapy with bleomycin or cisplatin

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 treatment options have been exhausted.

Eligibility Criteria

Inclusion Criteria: 1. Local or regional relapse of gynecological tumors in which standard treatment options have been exhausted. 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: 1. Visceral, bone or diffuse metastases. 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 dos

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