RecruitingPhase 2NCT05395962

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


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

92 participants

Start Date

Apr 8, 2022

Study Type

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing electrochemotherapy — using electrical pulses to help chemotherapy drugs enter cancer cells more effectively — in women with vulvar cancer that has come back after previous treatments. **You may be eligible if...** - You are 18 years old or older - You have vulvar cancer that has been confirmed by biopsy and has returned after prior treatment - You have already undergone multiple treatments (such as surgery, radiation, and/or chemotherapy) - You are no longer a candidate for standard treatments **You may NOT be eligible if...** - You have serious heart problems or a pacemaker - You have a known allergy to the chemotherapy drugs used (carboplatin or bleomycin) - Your cancer has spread to distant organs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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

DRUGCarboplatin

treatment with bleomycin and carboplatin in association with electroporation

DRUGBleomycin

treatment with bleomycin in association with electroporation


Locations(1)

IRCCS- Azienda Ospedaliera-Universitaria di Bologna

Bologna, Bo, Italy

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NCT05395962


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