Advanced Inoperable Vulva Carcinoma Clinical Trial
Official title:
Prospective Evaluation of Clinical Efficacy and Symptom Control Using Electrochemotherapy for the Inoperable Advanced Vulva Carcinoma
| Verified date | February 2020 |
| Source | University Women's Hospital Tübingen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Electrochemotherapy (ECT) with Bleomycin in non-operable advanced vulva carcinoma
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | December 31, 2019 |
| Est. primary completion date | June 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 55 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Women's Health | Tübingen |
| Lead Sponsor | Collaborator |
|---|---|
| University Women's Hospital Tübingen |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | local tumor control | according to RECIST criteria | Baseline | |
| Primary | Symptom control | exulceration, secretion | Baseline | |
| Secondary | Life quality | EORTC QLQ | Baseline, 3, 6 months | |
| Secondary | Pain | Visual scale | Baseline, 3, 6 months |