Electrochemotherapy for the Inoperable Vulva Carcinoma

February 6, 2020 updated by: University Women's Hospital Tübingen

Prospective Evaluation of Clinical Efficacy and Symptom Control Using Electrochemotherapy for the Inoperable Advanced Vulva Carcinoma

Electrochemotherapy (ECT) with Bleomycin in non-operable advanced vulva carcinoma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. .

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tübingen, Germany, 72076
        • Department of Women's Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ECT
Procedure: Electrochemotherapy
Bleomycin plus local electroporation of cutan accessible tumor tissue in patients with advanced inoperable vulva carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
local tumor control
Time Frame: Baseline
according to RECIST criteria
Baseline
Symptom control
Time Frame: Baseline
exulceration, secretion
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Life quality
Time Frame: Baseline, 3, 6 months
EORTC QLQ
Baseline, 3, 6 months
Pain
Time Frame: Baseline, 3, 6 months
Visual scale
Baseline, 3, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Women's Hospital Tübingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

May 3, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (Actual)

May 5, 2017

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 558/2015BO1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Inoperable Vulva Carcinoma

Clinical Trials on Electrochemotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe