Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05905315
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2022-12-12
Brief Title:
Primary Chemoradiation VS Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC
Sponsor:
The Netherlands Cancer Institute
Organization:
The Netherlands Cancer Institute
Study Overview
Official Title:
Primary Chemoradiation VS Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For Locally Advanced Vulvar Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-04
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:
VULCANIZE-II
Brief Summary:
A phase 2 randomised controlled trial will be performed in which the efficacy and safety of standard treatment primary chemoradiation consisting of 645 Gy in 30 fractions of external beam radiotherapy with weekly cisplatin for six weeks and experimental treatment NACT consisting of carboplatin and paclitaxel in a 3-weekly scheme will be compared in 98 patients with LAVC registered from eight national medical centres
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