Electrochemotherapy for the Inoperable Vulva Carcinoma

N/ACompletedNCT03142061

University Hospital Tuebingen50 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Inoperable Vulva Carcinoma

Interventions

ElectrochemotherapyPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Women's Health

Tübingen, Germany

Outcomes

Primary Outcomes

local tumor control

according to RECIST criteria

Time frame: Baseline

Symptom control

exulceration, secretion

Time frame: Baseline

Secondary Outcomes

Life quality

EORTC QLQ

Time frame: Baseline, 3, 6 months

Pain

Visual scale

Time frame: Baseline, 3, 6 months

Data from ClinicalTrials.gov

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