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

Study acronym: VULCANIZE-II
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 1, 2023 to Jan 1, 2024 · Study sites: 0 to 2 · Eligibility criteria expanded, about 17 wordsv2 Show 3 more changesShow less
    • Start date changed from estimate of Sep 1, 2023 to Jan 1, 2024
    • Study sites: 0 to 2
    • Eligibility criteria expanded, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov