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

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 fo...

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Autores principales: Lillehei, Kevin O, Kalkanis, Steven N, Liau, Linda M, Mydland, Dellann Elliott, Olson, Jeffrey, Paleologos, Nina A, Ryken, Timothy, Johnson, Tania, Scullin, Evan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Future Medicine Ltd 2017
Materias:
Clinical Trial Protocol
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5977275/
https://www.ncbi.nlm.nih.gov/pubmed/29206049
http://dx.doi.org/10.2217/cns-2017-0036
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author Lillehei, Kevin O
Kalkanis, Steven N
Liau, Linda M
Mydland, Dellann Elliott
Olson, Jeffrey
Paleologos, Nina A
Ryken, Timothy
Johnson, Tania
Scullin, Evan
author_facet Lillehei, Kevin O
Kalkanis, Steven N
Liau, Linda M
Mydland, Dellann Elliott
Olson, Jeffrey
Paleologos, Nina A
Ryken, Timothy
Johnson, Tania
Scullin, Evan
author_sort Lillehei, Kevin O
collection PubMed
description 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.
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spelling pubmed-59772752018-06-11 Rationale and design of the 500-patient, 3-year, and prospective Vigilant ObservatIon of GlIadeL WAfer ImplaNT registry Lillehei, Kevin O Kalkanis, Steven N Liau, Linda M Mydland, Dellann Elliott Olson, Jeffrey Paleologos, Nina A Ryken, Timothy Johnson, Tania Scullin, Evan CNS Oncol Clinical Trial Protocol 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. Future Medicine Ltd 2017-12-05 /pmc/articles/PMC5977275/ /pubmed/29206049 http://dx.doi.org/10.2217/cns-2017-0036 Text en © 2018 Kevin O Lillihei et al. This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License (http://creativecommons.org/licenses/by-nc-nd/4.0/)
spellingShingle Clinical Trial Protocol
Lillehei, Kevin O
Kalkanis, Steven N
Liau, Linda M
Mydland, Dellann Elliott
Olson, Jeffrey
Paleologos, Nina A
Ryken, Timothy
Johnson, Tania
Scullin, Evan
Rationale and design of the 500-patient, 3-year, and prospective Vigilant ObservatIon of GlIadeL WAfer ImplaNT registry
title Rationale and design of the 500-patient, 3-year, and prospective Vigilant ObservatIon of GlIadeL WAfer ImplaNT registry
title_full Rationale and design of the 500-patient, 3-year, and prospective Vigilant ObservatIon of GlIadeL WAfer ImplaNT registry
title_fullStr Rationale and design of the 500-patient, 3-year, and prospective Vigilant ObservatIon of GlIadeL WAfer ImplaNT registry
title_full_unstemmed Rationale and design of the 500-patient, 3-year, and prospective Vigilant ObservatIon of GlIadeL WAfer ImplaNT registry
title_short Rationale and design of the 500-patient, 3-year, and prospective Vigilant ObservatIon of GlIadeL WAfer ImplaNT registry
title_sort rationale and design of the 500-patient, 3-year, and prospective vigilant observation of gliadel wafer implant registry
topic Clinical Trial Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5977275/
https://www.ncbi.nlm.nih.gov/pubmed/29206049
http://dx.doi.org/10.2217/cns-2017-0036
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