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RECRUITING
NCT05395962
PHASE2

Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer

Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

View on ClinicalTrials.gov

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

DRUG

Carboplatin

treatment with bleomycin and carboplatin in association with electroporation

DRUG

Bleomycin

treatment with bleomycin in association with electroporation

Locations (1)

IRCCS- Azienda Ospedaliera-Universitaria di Bologna

Bologna, Bo, Italy