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Trial Title:
Electrochemotherapy for the Treatment of Vulvar Cancer
NCT ID:
NCT05916690
Condition:
Vulvar Cancer
Conditions: Official terms:
Vulvar Neoplasms
Bleomycin
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Electrochemotherapy with bleomycin or cisplatin
Description:
Combination of drug delivery platform (electroporation) and drug (bleomycin)
Arm group label:
Electrochemotherapy
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Oncology Ljubljana
Address:
City:
Ljubljana
Country:
Slovenia
Status:
Recruiting
Contact:
Last name:
Maja Cemazar
Start date:
March 1, 2021
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Institute of Oncology Ljubljana
Agency class:
Other
Source:
Institute of Oncology Ljubljana
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05916690
