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Electrochemotherapy for the Treatment of Vulvar Cancer

Primary Purpose

Vulvar Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Electrochemotherapy with bleomycin or cisplatin
Sponsored by
Institute of Oncology Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvar Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Local recurrence of vulvar cancer confirmed by histology The longest diameter of tumor 50 millimeters or less Age more than 18 years Life expectancy of more than 3 months Performance status according to Karnofsky ≥ 70 or < or 2 according to the WHO scale At least 2 weeks have passed since the last treatment The patient must be able to understand the treatment process and possible side effects that may occur during the treatment Signed informed consent form The patient must be presented at a Multidisciplinary Tumor Board Exclusion Criteria: Life-threatening infection and/or heart failure and/or liver failure and/or markedly impaired pulmonary function and/or other life-threatening systemic diseases Regional or distant metastases Age less than 18 years Major disturbances in the coagulation system (which do not respond to standard therapy - replacement of vitamin K or fresh frozen plasma) Exposure to cumulative bleomycin doses greater than 400 mg Impaired renal function (Creatinine > 150 µmol/L) Epilepsy Pregnancy Patients who are unable to understand the treatment process or refuse to be involved in the treatment process

Sites / Locations

  • Institute of Oncology LjubljanaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electrochemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Number of adverse events 1 month after the treatment
According to CTCAE v5.0
Number of adverse events 2 months after the treatment
According to CTCAE v5.0
Number of adverse events 3 months after the treatment
According to CTCAE v5.0
Number of adverse events 6 months after the treatment
According to CTCAE v5.0
Number of adverse events 9 months after the treatment
According to CTCAE v5.0
Number of adverse events 12 months after the treatment
According to CTCAE v5.0
Efficacy of electrochemotherapy
According to RECIST
Efficacy of electrochemotherapy
According to RECIST
Efficacy of electrochemotherapy
According to RECIST
Efficacy of electrochemotherapy
According to RECIST
Efficacy of electrochemotherapy
According to RECIST
Efficacy of electrochemotherapy
According to RECIST

Secondary Outcome Measures

Full Information

First Posted
June 1, 2023
Last Updated
June 14, 2023
Sponsor
Institute of Oncology Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT05916690
Brief Title
Electrochemotherapy for the Treatment of Vulvar Cancer
Official Title
Electrochemotherapy for the Treatment of Vulvar Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Oncology Ljubljana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electrochemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Electrochemotherapy with bleomycin or cisplatin
Intervention Description
Combination of drug delivery platform (electroporation) and drug (bleomycin)
Primary Outcome Measure Information:
Title
Number of adverse events 1 month after the treatment
Description
According to CTCAE v5.0
Time Frame
1 month
Title
Number of adverse events 2 months after the treatment
Description
According to CTCAE v5.0
Time Frame
2 months
Title
Number of adverse events 3 months after the treatment
Description
According to CTCAE v5.0
Time Frame
3 months
Title
Number of adverse events 6 months after the treatment
Description
According to CTCAE v5.0
Time Frame
6 months
Title
Number of adverse events 9 months after the treatment
Description
According to CTCAE v5.0
Time Frame
9 months
Title
Number of adverse events 12 months after the treatment
Description
According to CTCAE v5.0
Time Frame
12 months
Title
Efficacy of electrochemotherapy
Description
According to RECIST
Time Frame
1 month
Title
Efficacy of electrochemotherapy
Description
According to RECIST
Time Frame
2 months
Title
Efficacy of electrochemotherapy
Description
According to RECIST
Time Frame
3 months
Title
Efficacy of electrochemotherapy
Description
According to RECIST
Time Frame
6 months
Title
Efficacy of electrochemotherapy
Description
According to RECIST
Time Frame
9 months
Title
Efficacy of electrochemotherapy
Description
According to RECIST
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Local recurrence of vulvar cancer confirmed by histology The longest diameter of tumor 50 millimeters or less Age more than 18 years Life expectancy of more than 3 months Performance status according to Karnofsky ≥ 70 or < or 2 according to the WHO scale At least 2 weeks have passed since the last treatment The patient must be able to understand the treatment process and possible side effects that may occur during the treatment Signed informed consent form The patient must be presented at a Multidisciplinary Tumor Board Exclusion Criteria: Life-threatening infection and/or heart failure and/or liver failure and/or markedly impaired pulmonary function and/or other life-threatening systemic diseases Regional or distant metastases Age less than 18 years Major disturbances in the coagulation system (which do not respond to standard therapy - replacement of vitamin K or fresh frozen plasma) Exposure to cumulative bleomycin doses greater than 400 mg Impaired renal function (Creatinine > 150 µmol/L) Epilepsy Pregnancy Patients who are unable to understand the treatment process or refuse to be involved in the treatment process
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maja Cemazar
Phone
+386-1-5879-544
Email
mcemazar@onko-i.si
Facility Information:
Facility Name
Institute of Oncology Ljubljana
City
Ljubljana
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maja Cemazar

12. IPD Sharing Statement

Learn more about this trial

Electrochemotherapy for the Treatment of Vulvar Cancer

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