Actively Recruiting
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2022-05-27
92
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with vulvar cancer who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy), or patients not eligible for standard therapies. The study aims to: * Evaluate the oncology response to electroporation after administration of Bleomycin (BLM) + carboplatinum (CBP )to BLM alone in terms of local progression-free survival (LPFS) in women with relapsed vulvar cancer after multimodal treatments. * Compare quality of life (HR-QoL) in the two groups of patients with questionnaires (FACT-V, FACT-PAL, E5-5L-D5). * To compare Overall Survival in the two study arms. * To compare local and systemic toxicity, morbidity and mortality, intraoperative and post-operative complications among the two study arms. * To compare costs and cost-effectiveness between the two study arms.
CONDITIONS
Official Title
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63 18 years old
- Recurrent vulvar cancer confirmed by histological examination
- Patient who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy)
- Patient not eligible for standard therapies due to ECOG Performance Status 63 3
- Life expectancy more than three months
- Measurable disease according to RECIST 1.1
- Adequate bone marrow, liver, and kidney function with specified laboratory values
- Negative serum pregnancy test within 72 hours for females of childbearing potential
- Signed informed consent obtained prior to study procedures and treatment
You will not qualify if you...
- History of other malignancies in the previous five years, except basal cell carcinoma of the skin
- History of psychological, familial, sociological, or geographical condition preventing compliance with study protocol and follow-up
- Allergic reactions to Bleomycin, Carboplatin, or their excipients
- Evidence of pulmonary fibrosis
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS- Azienda Ospedaliera-Universitaria di Bologna
Bologna, Bo, Italy, 40138
Actively Recruiting
Research Team
A
Anna Myriam Perrone, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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