Electrochemotherapy of Gynecological Cancers

Study Overview
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Brief Summary
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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.

Official Title
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Electrochemotherapy of Gynecological Cancers

Conditions
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Gynecological Cancers

Intervention / Treatment
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* Combination Product: Electrochemotherapy with bleomycin or cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrochemotherapy of gynecological cancers<br> | Combination Product: Electrochemotherapy with bleomycin or cisplatin<br>* Electrochemotherapy with cisplatin or bleomycin of gynecological cancers<br>* Other names: Combination of drug delivery platform (electroporation) and drug (bleomycin or cisplatin);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of electrochemotherapy according to RECIST 1.1 criteria. | Effectiveness of electrochemotherapy in the treatment of local or regional recurrences of gynecological tumors in which standard treatment options have been exhausted. Effectiveness will be evaluated according to RECIST 1.1 criteria. | Changes from baseline regularly up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of electrochemotherapy according to CTCAE v5.0 criteria. | To determine safety of electrochemotherapy in the treatment of local or regional recurrences of gynecological tumors in which standard treatment options have been exhausted. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 criteria will be determined. | during hospitalization and up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrochemotherapy, Cisplatin, Bleomycin