Electrochemotherapy for the Inoperable Vulva Carcinoma

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03142061

Enrollment

Registered

2017-05-05

Start date

2017-06-01

Completion date

2019-12-31

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Inoperable Vulva Carcinoma

Brief summary

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

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. .

Interventions

PROCEDUREElectrochemotherapy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

55 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
local tumor control	Baseline	according to RECIST criteria
Symptom control	Baseline	exulceration, secretion

Secondary

Measure	Time frame	Description
Life quality	Baseline, 3, 6 months	EORTC QLQ
Pain	Baseline, 3, 6 months	Visual scale

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026