Evidence map›Paper›PMID 36964529›Full record

Trial reportBMC cancer2023

SAFESTEREO: phase II randomized trial to compare stereotactic radiosurgery with fractionated stereotactic radiosurgery for brain metastases.

J A Crouzen, A L Petoukhova, M L D Broekman, M Fiocco, U J Fisscher, J H Franssen, C G M Gadellaa-van Hooijdonk, M Kerkhof, M Kiderlen, M E Mast and 10 more

Registry-linked trialOpen access · goldFull text readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05346367 (Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.9field-weighted citation impact, top 6% 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.

NCT05346367 narecruitingnot on this map

Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases

TypeinterventionalSponsorHaaglanden Medical CentreRan2022 to 2027Enrolled130ConditionsBrain MetastasesArmsSRT, fSRT
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
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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

20 authors at 8 institutions in 1 country.

J A CrouzenHaaglanden Medical Center, The Hague, The Netherlands.
A L PetoukhovaHaaglanden Medical Center, The Hague, The Netherlands.
M L D BroekmanHaaglanden Medical Center, The Hague, The Netherlands.
M FioccoMathematical Institute of Leiden University, Leiden, The Netherlands.
U J FisscherHaaglanden Medical Center, The Hague, The Netherlands.
J H FranssenHaga Hospital, The Hague, The Netherlands.
C G M Gadellaa-van HooijdonkZuidwest Radiotherapeutisch Instituut, Roosendaal, Vlissingen, The Netherlands.
M KerkhofHaaglanden Medical Center, The Hague, The Netherlands.
M KiderlenHaaglanden Medical Center, The Hague, The Netherlands.
M E MastHaaglanden Medical Center, The Hague, The Netherlands.
C M van RijErasmus MC, Rotterdam, The Netherlands.
R Nandoe TewarieHaaglanden Medical Center, The Hague, The Netherlands.
M A E van de SandeInstituut Verbeeten, Tilburg, The Netherlands.
P P G van der ToornCatharina Hospital, Eindhoven, The Netherlands.
R VlasmanRadiotherapy Institute Friesland, Leeuwarden, The Netherlands.
M J VosHaaglanden Medical Center, The Hague, The Netherlands.
N C M G van der Voort van ZypHaaglanden Medical Center, The Hague, The Netherlands.
R G J WiggenraadHaaglanden Medical Center, The Hague, The Netherlands.
L M WiltinkLeiden University Medical Center, Leiden, The Netherlands.
J D ZindlerHaaglanden Medical Center, The Hague, The Netherlands. j.zindler@haaglandenmc.nl.ORCID http://orcid.org/0000-0002-3084-4568
Medisch Centrum Haaglanden · NLErasmus MC · NLHaga Hospital · NLInstituut Verbeeten · NLLeiden University · NLLeiden University Medical Center · NLRadboud University Nijmegen · NLRadiotherapeutisch Instituut Friesland · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStereotactic radiosurgery (SRS) is a frequently chosen treatment for patients with brain metastases and the number of long-term survivors is increasing. Brain necrosis (e.g. radionecrosis) is the most important long-term side effect of the treatment. Retrospective studies show a lower risk of radionecrosis and local tumor recurrence after fractionated stereotactic radiosurgery (fSRS, e.g. five fractions) compared with stereotactic radiosurgery in one or three fractions. This is especially true for patients with large brain metastases. As such, the 2022 ASTRO guideline of radiotherapy for brain metastases recommends more research to fSRS to reduce the risk of radionecrosis. This multicenter prospective randomized study aims to determine whether the incidence of adverse local events (either local failure or radionecrosis) can be reduced using fSRS versus SRS in one or three fractions in patients with brain metastases.

methodsPatients are eligible with one or more brain metastases from a solid primary tumor, age of 18 years or older, and a Karnofsky Performance Status ≥ 70. Exclusion criteria include patients with small cell lung cancer, germinoma or lymphoma, leptomeningeal metastases, a contraindication for MRI, prior inclusion in this study, prior surgery for brain metastases, prior radiotherapy for the same brain metastases (in-field re-irradiation). Participants will be randomized between SRS with a dose of 15-24 Gy in 1 or 3 fractions (standard arm) or fSRS 35 Gy in five fractions (experimental arm). The primary endpoint is the incidence of a local adverse event (local tumor failure or radionecrosis identified on MRI scans) at two years after treatment. Secondary endpoints are salvage treatment and the use of corticosteroids, bevacizumab, or antiepileptic drugs, survival, distant brain recurrences, toxicity, and quality of life. DISCUSSION: Currently, limiting the risk of adverse events such as radionecrosis is a major challenge in the treatment of brain metastases. fSRS potentially reduces this risk of radionecrosis and local tumor failure.

trial registrationClincalTrials.gov, trial registration number: NCT05346367 , trial registration date: 26 April 2022.

Indexed as

Brain NeoplasmsRadiation InjuriesRadiosurgeryAdolescentHumansProspective StudiesQuality of LifeRetrospective StudiesTreatment OutcomeBrain metastasesBrain necrosisFractionated stereotactic radiosurgery (fSRS)HypofractionationLocal tumor failureRadionecrosisStereotactic radiosurgery (SRS)

Identifiers

PMID36964529
PMCPMC10039548
OpenAlexW4360820024

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read11
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.