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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Combination of drug delivery platform (electroporation) and drug (bleomycin)
Institute of Oncology Ljubljana
Ljubljana, Slovenia
RECRUITINGNumber of adverse events 1 month after the treatment
According to CTCAE v5.0
Time frame: 1 month
Number of adverse events 2 months after the treatment
According to CTCAE v5.0
Time frame: 2 months
Number of adverse events 3 months after the treatment
According to CTCAE v5.0
Time frame: 3 months
Number of adverse events 6 months after the treatment
According to CTCAE v5.0
Time frame: 6 months
Number of adverse events 9 months after the treatment
According to CTCAE v5.0
Time frame: 9 months
Number of adverse events 12 months after the treatment
According to CTCAE v5.0
Time frame: 12 months
Response of the tumor to electrochemotherapy according to RECIST criteria
According to RECIST criteria
Time frame: 1 month
Response of the tumor to electrochemotherapy according to RECIST criteria
According to RECIST criteria
Time frame: 2 months
Response of the tumor to electrochemotherapy according to RECIST criteria
According to RECIST criteria
Time frame: 3 months
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Response of the tumor to electrochemotherapy according to RECIST criteria
According to RECIST criteria
Time frame: 6 months
Response of the tumor to electrochemotherapy according to RECIST criteria
According to RECIST criteria
Time frame: 9 months
Response of the tumor to electrochemotherapy according to RECIST criteria
According to RECIST criteria
Time frame: 12 months