Clinical Trial

Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC

Study acronym: VULCANIZE-II
Recruiting Phase 2
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Summary
A phase 2 randomised controlled trial will be performed in which the efficacy and safety of standard treatment (primary chemoradiation; consisting of 64.5 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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-06-06.
Status change: Not Yet Recruiting → Recruiting 2024-04-12
Trial Details
NCT Number NCT05905315
Lead Sponsor The Netherlands Cancer Institute
Conditions Locally Advanced Vulvar Carcinoma, Squamous Cell Carcinoma of the Vulva
Enrollment 98 participants
Start Date 2024-01-01
Primary Completion 2029-09-01 (estimated)
Study Completion 2029-09-01 (estimated)
Updated on ClinicalTrials.gov 2024-04-15