Back to resultsElectrochemotherapy for the Inoperable Vulva Carcinoma
Primary Purpose
Advanced Inoperable Vulva Carcinoma
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Electrochemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Inoperable Vulva Carcinoma
Eligibility Criteria
Inclusion Criteria:
- informed consent
- age ≥ 55 years (postmenopausal)
- histologically proved cutan accessible vulva carcinoma
- a maximum of 5 lesions ≥1 - ≤ 5 cm diameter; a maximum thickness of 3 cm
- applied electrochemotherapy with electroporation
Exclusion Criteria:
- Non compliant patients
- Patients with symptomatic or rapidly progredient metastasis outside of the vulva
Sites / Locations
- Department of Women's Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ECT
Arm Description
Outcomes
Primary Outcome Measures
local tumor control
according to RECIST criteria
Symptom control
exulceration, secretion
Secondary Outcome Measures
Life quality
EORTC QLQ
Pain
Visual scale
Full Information
NCT ID
NCT03142061
First Posted
May 3, 2017
Last Updated
February 6, 2020
Sponsor
University Women's Hospital Tübingen
1. Study Identification
Unique Protocol Identification Number
NCT03142061
Brief Title
Electrochemotherapy for the Inoperable Vulva Carcinoma
Official Title
Prospective Evaluation of Clinical Efficacy and Symptom Control Using Electrochemotherapy for the Inoperable Advanced Vulva Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Women's Hospital Tübingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Electrochemotherapy (ECT) with Bleomycin in non-operable advanced vulva carcinoma
Detailed Description
Prospective evaluation of tumor response towards ECT by photo documentation. In addition prospective documentation of life quality after ECT treatment as well as evaluation of pain. .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Inoperable Vulva Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ECT
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Electrochemotherapy
Intervention Description
Bleomycin plus local electroporation of cutan accessible tumor tissue in patients with advanced inoperable vulva carcinoma
Primary Outcome Measure Information:
Title
local tumor control
Description
according to RECIST criteria
Time Frame
Baseline
Title
Symptom control
Description
exulceration, secretion
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Life quality
Description
EORTC QLQ
Time Frame
Baseline, 3, 6 months
Title
Pain
Description
Visual scale
Time Frame
Baseline, 3, 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
informed consent
age ≥ 55 years (postmenopausal)
histologically proved cutan accessible vulva carcinoma
a maximum of 5 lesions ≥1 - ≤ 5 cm diameter; a maximum thickness of 3 cm
applied electrochemotherapy with electroporation
Exclusion Criteria:
Non compliant patients
Patients with symptomatic or rapidly progredient metastasis outside of the vulva
Facility Information:
Facility Name
Department of Women's Health
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Electrochemotherapy for the Inoperable Vulva Carcinoma
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