Clinical trial NCT05916690: Electrochemotherapy for the Treatment of Vulvar Cancer
Official title: Electrochemotherapy for the Treatment of Vulvar Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vulvar Cancer
Lead sponsor: Institute of Oncology Ljubljana
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Local recurrence of vulvar cancer confirmed by histology
2. The longest diameter of tumor 50 millimeters or less
3. Age more than 18 years
4. Life expectancy of more than 3 months
5. Performance status according to Karnofsky ≥ 70 or \< or 2 according to the WHO scale
6. At least 2 weeks have passed since the last treatment
7. The patient must be able to understand the treatment process and possible side effects that may occur during the treatment
8. Signed informed consent form
9. The patient must be presented at a Multidisciplinary Tumor Board

Exclusion Criteria:

1. Life-threatening infection and/or heart failure and/or liver failure and/or markedly impaired pulmonary function and/or other life-threatening systemic diseases
2. Regional or distant metastases
3. Age less than 18 years
4. Major disturbances in the coagulation system (which do not respond to standard therapy - replacement of vitamin K or fresh frozen plasma)
5. Exposure to cumulative bleomycin doses greater than 400 mg
6. Impaired renal function (Creatinine \> 150 µmol/L)
7. Epilepsy
8. Pregnancy
9. Patients who are unable to understand the treatment process or refuse to be involved in the treatment process

Primary outcomes:
measure: Number of adverse events 1 month after the treatment
timeFrame: 1 month
measure: Number of adverse events 2 months after the treatment
timeFrame: 2 months
measure: Number of adverse events 3 months after the treatment
timeFrame: 3 months
measure: Number of adverse events 6 months after the treatment
timeFrame: 6 months
measure: Number of adverse events 9 months after the treatment
timeFrame: 9 months
measure: Number of adverse events 12 months after the treatment
timeFrame: 12 months
measure: Response of the tumor to electrochemotherapy according to RECIST criteria
timeFrame: 1 month
measure: Response of the tumor to electrochemotherapy according to RECIST criteria
timeFrame: 2 months
measure: Response of the tumor to electrochemotherapy according to RECIST criteria
timeFrame: 3 months
measure: Response of the tumor to electrochemotherapy according to RECIST criteria
timeFrame: 6 months
measure: Response of the tumor to electrochemotherapy according to RECIST criteria
timeFrame: 9 months
measure: Response of the tumor to electrochemotherapy according to RECIST criteria
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Institute of Oncology Ljubljana
Study officials:
References: