Rationale and design of the 500-patient, 3-year, and prospective Vigilant ObservatIon of GlIadeL WAfer ImplaNT registry.

• Authors: Kevin O. Lillehei, University of Colorado; Steven N. Kalkanis, Henry Ford Hospital; Linda M. Liau, University of California Los Angeles; Dellann Elliott Mydland, EndBrainCancer Initiative; Jeffrey James Olson, Emory University; Nina A. Paleologos, Advocate Health Care; Timothy Ryken, Dartmouth-Hitchcock; Tania Johnson, Arbor Pharmaceuticals; Evan Scullin, Arbor Pharmaceuticals
• Journal Title: CNS Oncology
• Volume: Volume 7, Number 2
• Publisher: Future Medicine: Open Access Journals | 2018-04, Pages CNS08-CNS08
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.2217/cns-2017-0036
• Subjects: Biology, Neuroscience
• Keywords: BCNU wafers; chemotherapy; glioblastoma; high-grade glioma; multimodality; patterns of care; study protocol

Abstract

Implantation of biodegradable wafers impregnated with carmustine (BCNU) is one of the few chemotherapeutic modalities that have been evaluated in Phase III trials and approved by the US FDA for treatment of newly diagnosed high-grade glioma and recurrent glioblastoma. Enrolling up to 500 patients for 3-year follow-up at over 30 sites, the prospective Vigilant ObservatIon of GlIadeL WAfer ImplaNT (VIGILANT) registry (NCT02684838) will evaluate BCNU wafers for treatment of CNS malignancies in contemporary practice and in the new era of molecular tumor analysis. Subgroup analyses will include tumor type, molecular marker status, and treatment combinations. Interim analyses from the VIGILANT registry will be reported until complete results are available in 2024.