Evidence map›Paper›PMID 28687375›Full record

Trial reportThe Lancet. Oncology2017

Post-operative stereotactic radiosurgery versus observation for completely resected brain metastases: a single-centre, randomised, controlled, phase 3 trial.

Anita Mahajan, Salmaan Ahmed, Mary Frances McAleer, Jeffrey S Weinberg, Jing Li, Paul Brown, Stephen Settle, Sujit S Prabhu, Frederick F Lang, Nicholas Levine and 16 more

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00950001 (Efficacy of Post-Surgical Stereotactic Radiosurgery for Metastatic Brain Disease), which is not on this map. Cited by 395 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
395citing papers in PubMed, 15 pooled it
–field-weighted citation impact
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.

NCT00950001 phase3active not recruitingnot on this map

Efficacy of Post-Surgical Stereotactic Radiosurgery for Metastatic Brain Disease: A Randomized Trial

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2009 to 2027Enrolled132ConditionsMetastatic Malignant Neoplasm in the BrainArmsStereotactic Radiosurgery
3 · Its place in the literature

Who cites it

395 citing papers in PubMed, 15 syntheses or guidelines pooled it.

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  3. The role of preoperative stereotactic radiotherapy in the management of resectable brain metastases: A systematic review.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2026
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  11. DEGRO guideline for personalized radiotherapy of brain metastases and leptomeningeal carcinomatosis in patients with breast cancer.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2024
    Guideline
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335 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors.

Anita MahajanDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Salmaan AhmedDepartment of Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Mary Frances McAleerDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jeffrey S WeinbergDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jing LiDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Paul BrownDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Stephen SettleDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Sujit S PrabhuDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Frederick F LangDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Nicholas LevineDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Susan McGovernDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Erik SulmanDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Ian E McCutcheonDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Syed AzeemDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Daniel CahillDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Claudio TatsuiDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Amy B HeimbergerDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Sherise FergusonDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Amol GhiaDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Franco DemonteDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Shaan RazaDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Nandita Guha-ThakurtaDepartment of Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
James YangDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Raymond SawayaDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Kenneth R HessDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Ganesh RaoDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: grao@mdanderson.org.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundAfter brain metastasis resection, whole brain radiotherapy decreases local recurrence, but might cause cognitive decline. We did this study to determine if stereotactic radiosurgery (SRS) to the surgical cavity improved time to local recurrence compared with that for surgical resection alone.

methodsIn this randomised, controlled, phase 3 trial, we recruited patients at a single tertiary cancer centre in the USA. Eligible patients were older than 3 years, had a Karnofsky Performance Score of 70 or higher, were able to have an MRI scan, and had a complete resection of one to three brain metastases (with a maximum diameter of the resection cavity ≤4 cm). Patients were randomly assigned (1:1) with a block size of four to either SRS of the resection cavity (within 30 days of surgery) or observation. Patients were stratified by histology of the primary tumour, metastatic tumour size, and number of metastases. The primary endpoint was time to local recurrence in the resection cavity, assessed by blinded central review of brain MRI scans by the study neuroradiologist in the modified intention-to-treat population that analysed patients by randomised allocation but excluded patients found ineligible after randomisation. Participants and other members of the treatment team (excluding the neuroradiologist) were not masked to treatment allocation. The trial is registered with ClinicalTrials.gov, number NCT00950001, and is closed to new participants.

findingsBetween Aug 13, 2009, and Feb 16, 2016, 132 patients were randomly assigned to the observation group (n=68) or SRS group (n=64), with 128 patients available for analysis; four patients were ineligible (three from the SRS group and one from the observation group). Median follow-up was 11·1 months (IQR 4·8-20·4). 12-month freedom from local recurrence was 43% (95% CI 31-59) in the observation group and 72% (60-87) in the SRS group (hazard ratio 0·46 [95% CI 0·24-0·88]; p=0·015). There were no adverse events or treatment-related deaths in either group.

interpretationSRS of the surgical cavity in patients who have had complete resection of one, two, or three brain metastases significantly lowers local recurrence compared with that noted for observation alone. Thus, the use of SRS after brain metastasis resection could be an alternative to whole-brain radiotherapy.

fundingNational Institutes of Health.

Indexed as

Neoplasm Recurrence, LocalRadiosurgeryWatchful WaitingAdultAgedAged, 80 and overBrain NeoplasmsDisease-Free SurvivalFemaleFollow-Up StudiesHumansMagnetic Resonance ImagingMaleMetastasectomyMiddle AgedRadiotherapy, Adjuvant

Identifiers

PMID28687375
PMCPMC5560102

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.