Electrochemotherapy for the Inoperable Vulva Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03142061
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : October 17, 2018
Information provided by (Responsible Party):
University Women's Hospital Tübingen

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

Condition or disease Intervention/treatment Phase
Advanced Inoperable Vulva Carcinoma Procedure: Electrochemotherapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Clinical Efficacy and Symptom Control Using Electrochemotherapy for the Inoperable Advanced Vulva Carcinoma
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vulvar Cancer

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

Primary Outcome Measures :
  1. local tumor control [ Time Frame: Baseline ]
    according to RECIST criteria

  2. Symptom control [ Time Frame: Baseline ]
    exulceration, secretion

Secondary Outcome Measures :
  1. Life quality [ Time Frame: Baseline, 3, 6 months ]

  2. Pain [ Time Frame: Baseline, 3, 6 months ]
    Visual scale

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03142061

Contact: Eva-Maria Grischke +4970712982211

Department of Women's Health Recruiting
Tübingen, Germany, 72076
Contact: Harald Seeger, Prof. Dr.         
Sponsors and Collaborators
University Women's Hospital Tübingen

Responsible Party: University Women's Hospital Tübingen Identifier: NCT03142061     History of Changes
Other Study ID Numbers: 558/2015BO1
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Vulvar Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vulvar Diseases
Genital Diseases, Female