Evidence map›Paper›PMID 29466961›Full record

Trial reportBMC cancer2018

A randomised trial to compare cognitive outcome after gamma knife radiosurgery versus whole brain radiation therapy in patients with multiple brain metastases: research protocol CAR-study B.

Wietske C M Schimmel, Eline Verhaak, Patrick E J Hanssens, Karin Gehring, Margriet M Sitskoorn

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02953717 (A Prospective Randomized Study to Compare Cognitive Outcome After Stereotactic Radiosurgery or Whole Brain Radiation Therapy in Patients With 11-20 Brain Metastases), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 16% 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.

NCT02953717 nacompletednot on this map

A Prospective Randomized Study to Compare Cognitive Outcome After Stereotactic Radiosurgery or Whole Brain Radiation Therapy in Patients With 11-20 Brain Metastases

TypeinterventionalSponsorElisabeth-TweeSteden ZiekenhuisRan2016 to 2023Enrolled81ConditionsNeoplasm MetastasisArmsGamma Knife radiosurgery, Whole Brain Radiation Therapy
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. 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

5 authors at 2 institutions in 1 country.

Wietske C M SchimmelGamma Knife Centre Tilburg, Elisabeth TweeSteden Hospital, Hilvarenbeekseweg 60, 5022, GC, Tilburg, The Netherlands. w.c.m.schimmel@tilburguniversity.edu.
Eline VerhaakGamma Knife Centre Tilburg, Elisabeth TweeSteden Hospital, Hilvarenbeekseweg 60, 5022, GC, Tilburg, The Netherlands.
Patrick E J HanssensGamma Knife Centre Tilburg, Elisabeth TweeSteden Hospital, Hilvarenbeekseweg 60, 5022, GC, Tilburg, The Netherlands.
Karin GehringGamma Knife Centre Tilburg, Elisabeth TweeSteden Hospital, Hilvarenbeekseweg 60, 5022, GC, Tilburg, The Netherlands.
Margriet M SitskoornDepartment Neurosurgery, Elisabeth-TweeSteden Hospital, Hilvarenbeekseweg 60, 5022, GC, Tilburg, The Netherlands.
Elisabeth-TweeSteden Ziekenhuis · NLTilburg University · NL

Funding

ZonMw (Dutch organization for Health Research and Development) Project Number 842003006
6 · The paper itself

Abstract

backgroundGamma Knife radiosurgery (GKRS) is increasingly applied in patients with multiple brain metastases and is expected to have less adverse effects in cognitive functioning than whole brain radiation therapy (WBRT). Effective treatment with the least negative cognitive side effects is increasingly becoming important, as more patients with brain metastases live longer due to more and better systemic treatment options. There are no published randomized trials yet directly comparing GKRS to WBRT in patients with multiple brain metastases that include objective neuropsychological testing.

methodsCAR-Study B is a prospective randomised trial comparing cognitive outcome after GKRS or WBRT in adult patients with 11-20 newly diagnosed brain metastases on a contrast-enhanced MRI-scan, KPS ≥70 and life expectancy of at least 3 months. Randomisation by the method of minimization, is stratified by the cumulative tumour volume in the brain, systemic treatment, KPS, histology, baseline cognitive functioning and age. The primary endpoint is the between-group difference in the percentage of patients with significant memory decline at 3 months. Secondary endpoints include overall survival, local control, development of new brain metastases, cognitive functioning over time, quality of life, depression, anxiety and fatigue. Cognitive functioning is assessed by a standardised neuropsychological test battery. Assessments (cognitive testing, questionnaires and MRI-scans) are scheduled at baseline and at 3, 6, 9, 12 and 15 months after treatment. DISCUSSION: Knowledge gained from this trial may be used to inform individual patients with BM more precisely about the cognitive effects they can expect from treatment, and to assist both doctors and patients in making (shared) individual treatment decisions. This trial is currently recruiting. Target accrual: 23 patients at 3-months follow-up in both groups.

trial registrationThe Netherlands Trials Register number NTR5463. ClinicalTrials.gov registration number NCT02953717 , first received October 27, 2016, 8 patients were enrolled in this study on 31 July 2017.

Indexed as

Antineoplastic ProtocolsRadiosurgeryAdultBrain NeoplasmsCognitionHumansMiddle AgedNeuropsychological TestsProspective StudiesQuality of LifeRadiotherapyTreatment OutcomeYoung AdultBrain metastasesCognitive functioningGamma knife radiosurgeryHopkins verbal learning testNeuropsychological assessmentQuality of lifeStereotactic radiosurgeryWhole brain radiation therapy

Identifiers

PMID29466961
PMCPMC5822552
OpenAlexW2794539335

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.