Evidence map›Paper›PMID 30170568›Full record

Trial reportBMC cancer2018

Local response and pathologic fractures following stereotactic body radiotherapy versus three-dimensional conformal radiotherapy for spinal metastases - a randomized controlled trial.

Tanja Sprave, Vivek Verma, Robert Förster, Ingmar Schlampp, Katharina Hees, Thomas Bruckner, Tilman Bostel, Rami Ateyah El Shafie, Thomas Welzel, Nils Henrik Nicolay and 2 more

Registry-linked trialOpen access · goldAbstract readRandomized 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 NCT02358720 (Single-fraction IMRT Versus External Beam Radiotherapy for Patients With Spine Bone Metastases), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
4.3field-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.

NCT02358720 phase1 / phase2unknown statusnot on this map

Single-fraction IMRT Versus External Beam Radiotherapy for Patients With Spine Bone Metastases

TypeinterventionalSponsorHeidelberg UniversityRan2014 to 2016Enrolled60ConditionsPainArmsArm A, Arm B
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.

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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

12 authors at 2 institutions in 2 countries.

Tanja SpraveDepartment of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Vivek VermaDepartment of Radiation Oncology, Allegheny General Hospital, Pittsburgh, PA, USA.
Robert FörsterDepartment of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Ingmar SchlamppDepartment of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Katharina HeesDepartment of Medical Biometry, University Hospital of Heidelberg, Im Neuenheimer Feld 305, 69120, Heidelberg, Germany.
Thomas BrucknerDepartment of Radiation Oncology, Allegheny General Hospital, Pittsburgh, PA, USA.
Tilman BostelDepartment of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Rami Ateyah El ShafieDepartment of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Thomas WelzelDepartment of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Nils Henrik NicolayDepartment of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Jürgen DebusDepartment of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Harald RiefDepartment of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. harald.rief@med.uni-heidelberg.de.ORCID http://orcid.org/0000-0003-3610-973X
Heidelberg University · DEAllegheny General Hospital · US

Funding

Klaus Tschira Stiftung 00.237.2013
6 · The paper itself

Abstract

backgroundThis was a prespecified secondary analysis of a randomized trial, which analyzed bone density following stereotactic body radiotherapy (SBRT) versus conventional three-dimensional conformal radiotherapy (3DCRT) as part of palliative management of painful spinal metastases.

methodsFifty-five patients were enrolled in this single-institutional randomized exploratory trial (NCT02358720). Participants were randomly assigned to receive SBRT (single-fraction 24 Gy) or 3DCRT (30 Gy/10 fractions). Quantitative bone density was evaluated at baseline, 3 and 6 months in both irradiated and unirradiated spinal bodies, along with rates of pathologic fractures and vertebral compression fractures.

resultsAs compared to baseline, bone density became significantly higher at 3 and 6 months following SBRT by a median of 33.8% and 72.1%, respectively (p < 0.01 for both). These figures in the 3DCRT cohort were 32.9% and 41.2%, respectively (p < 0.01 for both). There were no statistical differences in bone density between SBRT and 3DCRT at 3 (p = 0.629) or 6 months (p = 0.327). Subgroup analysis of osteolytic metastases showed an increase in bone density relative to baseline in the SBRT (but not 3DCRT) arm. Bone density in unaffected vertebrae did not show substantial changes in either group. The 3-month incidence of new pathological fractures was 8.7% in the SBRT arm vs. 4.3% in the 3DCRT arm.

conclusionsDespite high ablative doses in the SBRT arm, the significant increase in bone density after 3 and 6 months was similar to that of 3DCRT. Our trial demonstrated a moderate rate of subsequent pathological fracture after SBRT. Future randomized investigations with larger sample sizes are recommended.

trial registrationwww.clinicaltrials.gov : NCT02358720 on 9nd of February 2015.

Indexed as

AgedBone DensityFemaleFractures, SpontaneousHumansMagnetic Resonance ImagingMaleMiddle AgedPalliative CareRadiosurgeryRadiotherapy, ConformalSpinal FracturesSpinal NeoplasmsTomography, X-Ray ComputedTreatment OutcomeBone densityBone metastasesPalliative radiotherapySpineStereotactic body radiation therapy

Identifiers

PMID30170568
PMCPMC6119304
OpenAlexW2888917325

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.