Electrochemotherapy for the Inoperable Vulva Carcinoma

University Hospital Tuebingen

Status: Completed

Conditions: Advanced Inoperable Vulva Carcinoma

Treatments: Procedure: Electrochemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03142061

558/2015BO1

Details and patient eligibility

About

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

Full 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. .

Enrollment: 50 patients

Sex: Female

Ages: 55+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

ECT

Experimental group

Treatment:

Procedure: Electrochemotherapy