Electrochemotherapy for the Treatment of Vulvar Cancer

Not Applicable

Recruiting

• Conditions: Vulvar Cancer
• Interventions: Drug: Electrochemotherapy with bleomycin or cisplatin

• Registration Number: NCT05916690
• Lead Sponsor: Institute of Oncology Ljubljana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-23
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electrochemotherapy	Electrochemotherapy with bleomycin or cisplatin	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events 1 month after the treatment	1 month	According to CTCAE v5.0
Number of adverse events 3 months after the treatment	3 months	According to CTCAE v5.0
Number of adverse events 6 months after the treatment	6 months	According to CTCAE v5.0
Number of adverse events 9 months after the treatment	9 months	According to CTCAE v5.0
Number of adverse events 12 months after the treatment	12 months	According to CTCAE v5.0
Number of adverse events 2 months after the treatment	2 months	According to CTCAE v5.0
Response of the tumor to electrochemotherapy according to RECIST criteria	12 months	According to RECIST criteria

Trial Locations

Locations (1)

Institute of Oncology Ljubljana; 🇸🇮 Ljubljana, Slovenia