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Electrochemotherapy is a local treatment modality with effectiveness comparable to other local ablation techniques. With electrochemotherapy 80% objective response can be achieved and is suitable for the treatment of different types of tumors. The method is based on increased drug delivery to cells previously exposed to electroporation. The most commonly used cytotoxic agents are bleomycin and cisplatin. The aim of the proposed clinical trial is to determine the efficacy, feasibility and safety of electrochemotherapy in the treatment of vulvar cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrochemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrochemotherapy with bleomycin or cisplatin | Drug | Combination of drug delivery platform (electroporation) and drug (bleomycin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events 1 month after the treatment | According to CTCAE v5.0 | 1 month |
| Number of adverse events 2 months after the treatment | According to CTCAE v5.0 | 2 months |
| Number of adverse events 3 months after the treatment | According to CTCAE v5.0 | 3 months |
| Number of adverse events 6 months after the treatment | According to CTCAE v5.0 | 6 months |
| Number of adverse events 9 months after the treatment | According to CTCAE v5.0 | 9 months |
| Number of adverse events 12 months after the treatment | According to CTCAE v5.0 | 12 months |
| Response of the tumor to electrochemotherapy according to RECIST criteria | According to RECIST criteria | 1 month |
| Response of the tumor to electrochemotherapy according to RECIST criteria | According to RECIST criteria | 2 months |
| Response of the tumor to electrochemotherapy according to RECIST criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maja Cemazar | Contact | +386-1-5879-544 | mcemazar@onko-i.si |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Oncology Ljubljana | Recruiting | Ljubljana | Slovenia |
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| ID | Term |
|---|---|
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D053672 | Electrochemotherapy |
| D001761 | Bleomycin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000092722 | Electroporation Therapies |
| D018274 | Electroporation |
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According to RECIST criteria |
| 3 months |
| Response of the tumor to electrochemotherapy according to RECIST criteria | According to RECIST criteria | 6 months |
| Response of the tumor to electrochemotherapy according to RECIST criteria | According to RECIST criteria | 9 months |
| Response of the tumor to electrochemotherapy according to RECIST criteria | According to RECIST criteria | 12 months |
| D014845 |
| Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D003584 |
| Cytological Techniques |
| 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 |