Evidence map›Paper›PMID 33836671›Full record

ArticleBMC cancer2021

A prospective interventional study evaluating seizure activity during a radiotherapy course for high-grade gliomas (SURF-ROGG).

Dirk Rades, Jaspar Witteler, Denise Olbrich, Peter Trillenberg, Steven E Schild, Soeren Tvilsted, Troels W Kjaer

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04552756 (SeizURe Frequency During a Radiotherapy COurse for High-Grade Gliomas), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.8field-weighted citation impact, top 28% 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.

NCT04552756 naterminatednot on this map

SeizURe Frequency During a Radiotherapy COurse for High-Grade Gliomas

TypeinterventionalSponsorUniversity Hospital Schleswig-HolsteinRan2021 to 2022Enrolled23ConditionsHigh-grade GliomaArmsSeizure Diary
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
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

7 authors at 3 institutions in 3 countries.

Dirk RadesDepartment of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany. rades.dirk@gmx.net.
Jaspar WittelerDepartment of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany.
Denise OlbrichThe Centre for Clinical Trials Lübeck, Lübeck, Germany.
Peter TrillenbergDepartment of Neurology, University of Lübeck, Lübeck, Germany.
Steven E SchildDepartment of Radiation Oncology, Mayo Clinic Scottsdale, Scottsdale, AZ, USA.
Soeren TvilstedResearch Projects and Clinical Optimization, Zealand University Hospital, Koege, Denmark.
Troels W KjaerNeurological Department, Zealand University Hospital, Roskilde, Denmark.
University of Lübeck · DEZealand University Hospital · DKMayo Clinic in Arizona · US

Funding

European Regional Development Fund (Interreg) 087-1.1-18
6 · The paper itself

Abstract

backgroundGliomas are often associated with symptoms including seizures. Most patients with high-grade gliomas are treated with radiotherapy or radio-chemotherapy. Since irradiation causes inflammation, it may initially aggravate symptoms. Studies focusing on seizure activity during radiotherapy for gliomas are not available. Such knowledge may improve patient monitoring and anti-epileptic treatment. This study evaluates seizure activity during radiotherapy for high-grade gliomas.

methodsThe primary objective this prospective interventional study is the evaluation of seizure activity during a course of radiotherapy for high-grade gliomas. Progression of seizure activity is defined as increased frequency of seizures by > 50%, increased severity of seizures, or initiation/increase by ≥25% of anti-epileptic medication. Seizure frequency up to 6 weeks following radiotherapy and electroencephalography activity typical for epilepsy will also be evaluated. Patients keep a seizure diary during and up to 6 weeks following radiotherapy. Every day, they will document number (and type) of seizures and anti-epileptic medication. Once a week, the findings of the diary are checked and discussed with a neurologist to initiate or adjust anti-epileptic medication, if necessary. Patients complete a questionnaire regarding their satisfaction with the seizure diary. If the dissatisfaction rate is > 40%, the seizure diary will be considered not suitable for the investigated indication. Thirty-five patients (32 patients plus drop-outs) should be enrolled. With this sample size, a one-sample binomial test with a one-sided significance level of 2.5% has a power of 80% to yield statistical significance, if the rate of patients with progression of seizure activity is 30% (rate under the alternative hypothesis), assuming a 'natural' background progression-rate of 10% without radiotherapy (null hypothesis). DISCUSSION: If an increase in seizure activity during a course of radiotherapy for high-grade glioma occurs, the findings of this study may pave the way for a larger prospective trial and will likely lead to closer patient monitoring and better anti-epileptic treatment.

trial registrationclinicaltrials.gov ( NCT04552756 ); registered on 16th of September, 2020.

Indexed as

AnticonvulsantsBrain NeoplasmsChemoradiotherapyCranial IrradiationDisease ManagementDisease SusceptibilityElectroencephalographyFemaleGliomaHumansMaleNeoplasm GradingNeoplasm StagingSeizuresSymptom AssessmentTreatment OutcomeAnticonvulsantsHigh-grade gliomaRadio-chemotherapyRadiotherapySeizure diarySeizures

Identifiers

PMID33836671
PMCPMC8033669
OpenAlexW3147913258

What OpenQuestion holds

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LicenceCC BY
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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.