Evidence map›Paper›PMID 29206049›Full record

Observational studyCNS oncology2018

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

Kevin O Lillehei, Steven N Kalkanis, Linda M Liau, Dellann Elliott Mydland, Jeffrey Olson, Nina A Paleologos, Timothy Ryken, Tania Johnson, Evan Scullin

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in CNS oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02684838 (Vigilant ObservatIon of GlIadeL WAfer ImplaNT), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02684838 completednot on this map

Vigilant ObservatIon of GlIadeL WAfer ImplaNT (VIGILANT) Registry: A Multicenter, Observational Registry to Collect Information on the Safety and Effectiveness of Gliadel® Wafer (Carmustine Implant) Used in Usual Medical Practice

TypeobservationalSponsorArbor Pharmaceuticals, Inc.Ran2016 to 2025Enrolled272ConditionsCNS Tumor
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Glioma Cell Membrane-Coated CaCOInternational journal of nanomedicine · 2026
    Article
  4. Review
  5. Implantable devices for resected glioblastoma therapy.Asian journal of pharmaceutical sciences · 2025
    Article
  6. Review
  7. Implantation of carmustine wafers (GliadelJournal of neuro-oncology · 2020
    Article
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 8 institutions in 1 country.

Kevin O LilleheiDepartment of Neurosurgery, University of Colorado School of Medicine, Denver, CO, 80045, USA.
Steven N KalkanisDepartment of Neurosurgery, Henry Ford Hospital, Detroit, MI, 48202, USA.
Linda M LiauDepartment of Neurosurgery, David Geffen School of Medicine, UCLA, Los Angeles, 90095, CA, USA.
Dellann Elliott MydlandEndBrainCancer Initiative, Redmond, WA, 98052, USA.
Jeffrey OlsonDepartment of Neurosurgery, Emory University, Atlanta, GA, 30322, USA.
Nina A PaleologosDepartment of Neurology, Advocate Healthcare, Chicago, IL, 60515, USA.
Timothy RykenDepartment of Neurosurgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH, 03756, USA.
Tania JohnsonArbor Pharmaceuticals, LLC, Atlanta, GA, 30328, USA.
Evan ScullinArbor Pharmaceuticals, LLC, Atlanta, GA, 30328, USA.
Arbor Pharmaceuticals (United States) · USAdvocate Health Care · USDartmouth–Hitchcock Medical Center · USEmory University · USHenry Ford Hospital · USSpencer Technologies (United States) · USUniversity of California, Los Angeles · USUniversity of Colorado Denver · US

Funding

UCLA SPORE in Brain CancerP50CA211015 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI David A. Nathanson · 2017 to 2026
$25.2M
NCI NIH HHS P50 CA211015
6 · The paper itself

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.

Indexed as

Antineoplastic AgentsBiomarkers, TumorCarmustineCentral Nervous System NeoplasmsDecanoic AcidsDrug ImplantsFollow-Up StudiesHumansPolyestersProspective StudiesRegistriesResearch DesignUnited StatesAntineoplastic AgentsBiomarkers, TumorCarmustinecarmustine, poliferprosan 20 drug combinationDecanoic AcidsDrug ImplantsPolyestersBCNU waferschemotherapyglioblastomahigh-grade gliomamultimodalitypatterns of carestudy protocol

Identifiers

PMID29206049
PMCPMC5977275
OpenAlexW2772775100

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.