Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer: the ElechtraPlatinum Study. A Randomized Controlled Trial
IRCCS Azienda Ospedaliero-Universitaria di Bologna
92 participants
Apr 8, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
treatment with bleomycin and carboplatin in association with electroporation
treatment with bleomycin in association with electroporation
Locations(1)
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NCT05395962