Electrochemotherapy for the Inoperable Vulva Carcinoma

NCT ID: NCT03142061

Last Updated: 2024-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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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. .

Conditions

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Advanced Inoperable Vulva Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ECT

Group Type EXPERIMENTAL

Electrochemotherapy

Intervention Type PROCEDURE

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

Interventions

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Electrochemotherapy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Women's Health

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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558/2015BO1

Identifier Type: -

Identifier Source: org_study_id

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