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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrochemotherapy of gynecological cancers | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrochemotherapy with bleomycin or cisplatin | Combination Product | Electrochemotherapy with cisplatin or bleomycin of gynecological cancers |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregor Serša, PhD | Contact | +386 1 5879 434 | gsersa@onko-i.si | |
| Maja Čemažar, PhD | Contact | +386 1 5879 544 | mcemazar@onko-i.si |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of oncology Ljubljna | Recruiting | Ljubljana | 1000 | Slovenia |
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| ID | Term |
|---|---|
| D053672 | Electrochemotherapy |
| D001761 | Bleomycin |
| D002945 | Cisplatin |
| D018274 | Electroporation |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000092722 | Electroporation Therapies |
| D003584 | Cytological Techniques |
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|
| D019411 |
| Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |