Study of electrochemotherapy with carboplatinum and bleomycin vs. bleomycin in vulvar cancer

The company IRCCS Azienda Ospedaliero-Universitaria di Bologna is commencing recruitment for the clinical trial of the Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer.

The trial officially began on the April 8, 2022 and is planned to complete on April 7, 2027.

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.

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT05395962.