Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05395962
Status:
RECRUITING
Last Update Posted:
2022-05-27
First Post:
2022-05-11
Brief Title:
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer
Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study Overview
Official Title:
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer the ElechtraPlatinum Study A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Elechtra
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None