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Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Summary
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.
Official title: Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer: the ElechtraPlatinum Study. A Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2022-04-08
Completion Date
2027-04-07
Last Updated
2022-05-27
Healthy Volunteers
No
Conditions
Interventions
Carboplatin
treatment with bleomycin and carboplatin in association with electroporation
Bleomycin
treatment with bleomycin in association with electroporation
Locations (1)
IRCCS- Azienda Ospedaliera-Universitaria di Bologna
Bologna, Bo, Italy