Electrochemotherapy for the Treatment of Vulvar Cancer

Vulvar Cancer Clinical Trial

Official title:

Electrochemotherapy for the Treatment of Vulvar Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05916690
• Other study ID #: ERID-KSOPKR-0042/2021
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Institute of Oncology Ljubljana
• Contact: Maja Cemazar
• Phone: +386-1-5879-544
• Email: mcemazar[@]onko-i.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vulvar Cancer
• Vulvar Neoplasms

Intervention

Drug:
• Electrochemotherapy with bleomycin or cisplatin
Combination of drug delivery platform (electroporation) and drug (bleomycin)

Locations

Country	Name	City	State
Slovenia	Institute of Oncology Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Oncology Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events 1 month after the treatment	According to CTCAE v5.0	1 month
Primary	Number of adverse events 2 months after the treatment	According to CTCAE v5.0	2 months
Primary	Number of adverse events 3 months after the treatment	According to CTCAE v5.0	3 months
Primary	Number of adverse events 6 months after the treatment	According to CTCAE v5.0	6 months
Primary	Number of adverse events 9 months after the treatment	According to CTCAE v5.0	9 months
Primary	Number of adverse events 12 months after the treatment	According to CTCAE v5.0	12 months
Primary	Response of the tumor to electrochemotherapy according to RECIST criteria	According to RECIST criteria	1 month
Primary	Response of the tumor to electrochemotherapy according to RECIST criteria	According to RECIST criteria	2 months
Primary	Response of the tumor to electrochemotherapy according to RECIST criteria	According to RECIST criteria	3 months
Primary	Response of the tumor to electrochemotherapy according to RECIST criteria	According to RECIST criteria	6 months
Primary	Response of the tumor to electrochemotherapy according to RECIST criteria	According to RECIST criteria	9 months
Primary	Response of the tumor to electrochemotherapy according to RECIST criteria	According to RECIST criteria	12 months