MedTrace Logo

Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer

NCT05395962 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2022-05-27

No results posted yet for this study

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.

Conditions

  • Vulvar Cancer

Interventions

DRUG

Carboplatin

treatment with bleomycin and carboplatin in association with electroporation

DRUG

Bleomycin

treatment with bleomycin in association with electroporation

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-08
Primary Completion
2025-04-07
Completion
2027-04-07

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05395962 on ClinicalTrials.gov