Electrochemotherapy for the Inoperable Vulva Carcinoma

Not Applicable

Completed

• Conditions: Advanced Inoperable Vulva Carcinoma
• Interventions: Procedure: Electrochemotherapy

• Registration Number: NCT03142061
• Lead Sponsor: University Hospital Tuebingen

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. .

Study Timeline

• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-05
• Study Start: 2017-06-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ECT	Electrochemotherapy	-

Primary Outcome Measures

Name	Time	Method
Symptom control	Baseline	exulceration, secretion
local tumor control	Baseline	according to RECIST criteria

Secondary Outcome Measures

Name	Time	Method
Pain	Baseline, 3, 6 months	Visual scale
Life quality	Baseline, 3, 6 months	EORTC QLQ

Trial Locations

Locations (1)

Department of Women's Health; 🇩🇪 Tübingen, Germany