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OpenTrials
Completed

NCT Number: NCT03142061

Electrochemotherapy for the Inoperable Vulva Carcinoma

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

Completed

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Key information

Conditions

Advanced Inoperable Vulva Carcinoma

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Women's Health

Tübingen, 72076, Germany

About this study

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. .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrochemotherapy

Procedure

Bleomycin plus local electroporation of cutan accessible tumor tissue in patients with advanced inoperable vulva carcinoma

Primary outcomes

  1. local tumor control

    Time frame: Baseline

    according to RECIST criteria

  2. Symptom control

    Time frame: Baseline

    exulceration, secretion

Secondary outcomes

  1. Life quality

    Time frame: Baseline, 3, 6 months

    EORTC QLQ

  2. Pain

    Time frame: Baseline, 3, 6 months

    Visual scale

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 5, 2017
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.