Electrochemotherapy for the Treatment of Vulvar Cancer

Launched by INSTITUTE OF ONCOLOGY LJUBLJANA · Jun 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called electrochemotherapy for vulvar cancer, which is a type of cancer that affects the external female genitalia. Electrochemotherapy works by using electrical pulses to help deliver cancer-fighting drugs directly into the tumor cells, making the treatment more effective. The trial aims to see how well this method works, how safe it is, and whether it can be easily used in patients with vulvar cancer. Researchers hope to find that this treatment can help many patients with local tumors, as previous studies have shown good results.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed local recurrence of vulvar cancer that is 50 millimeters or smaller. They should also be in good overall health, with a life expectancy of more than three months. Patients will need to sign a consent form, understand the treatment process, and be part of a team that includes various healthcare professionals who will discuss their case. If you or someone you know might be interested, it's important to consider these criteria and speak with a healthcare provider for more information about participation and potential benefits.

Gender

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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