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NCT05905315: VULCANIZE-II

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

Recruiting now Phase 2 Last updated 15 April 2024
What this trial tests

Phase 2 trial testing Paclitaxel and Carboplatin in Locally Advanced Vulvar Carcinoma in 98 participants. Currently enrolling.

Timeline
1 January 2024
Primary endpoint
1 September 2029
1 September 2029

Quick facts

Lead sponsorThe Netherlands Cancer Institute
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment98
Start date1 January 2024
Primary completion1 September 2029
Estimated completion1 September 2029
Sites2 locations across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

The Netherlands Cancer Institute

Who can join

18 and older, female only, with Locally Advanced Vulvar Carcinoma or Squamous Cell Carcinoma of the Vulva. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Primary chemoradiation versus neoadjuvant chemotherapy followed by surgery as treatment strategy for locally advanced vulvar carcinoma (VULCANize2).
    Amant F, van Velzen AF, Reyners A, Zijlmans H, et al · · 2024 · cited 2× · PMID 38719277 · DOI 10.1136/ijgc-2024-005493

Verify or expand the search:

Other trials of Paclitaxel and Carboplatin

Trials testing the same drug.

Other The Netherlands Cancer Institute trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05905315.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing