Evidence map›Paper›PMID 22511344›Full record

Trial reportCancer2012

Phase 1/2 trial of single-session stereotactic body radiotherapy for previously unirradiated spinal metastases.

Amit K Garg, Almon S Shiu, James Yang, Xin-Shelley Wang, Pamela Allen, Barry W Brown, Patricia Grossman, Erik K Frija, Mary Frances McAleer, Syed Azeem and 3 more

Abstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 81 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 6 pooled it
13.5field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

81 citing papers in PubMed, 6 syntheses or guidelines pooled it, 211 citations in OpenAlex.

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  7. [Value of postoperative stereotaxic body radiation therapy for spinal metastases].Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2017
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21 more citing papers are in PubMed but not listed here.

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

13 authors at 2 institutions in 1 country.

Amit K GargDepartment of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, TX, USA.
Almon S Shiu
James Yang
Xin-Shelley Wang
Pamela Allen
Barry W Brown
Patricia Grossman
Erik K Frija
Mary Frances McAleer
Syed Azeem
Paul D Brown
Laurence D Rhines
Eric L Chang
The University of Texas MD Anderson Cancer Center · USKeck Hospital of USC · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Reducing the Symptom Burden Produced by Aggressive Cancer TherapiesR01CA026582 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI CLEELAND, CHARLES S · 1986 to 2013
$7.3M
NCI NIH HHS P30 CA016672NCI NIH HHS R01 CA026582
6 · The paper itself

Abstract

backgroundIn this phase 1/2 study, the authors tested the hypothesis that single-fraction stereotactic body radiotherapy (SBRT) for previously unirradiated spinal metastases is a safe, feasible, and efficacious treatment approach.

methodsAll patients were evaluated by a multidisciplinary team. Spinal magnetic resonance imaging studies were obtained before treatment and at regular intervals to define both target volume and response to treatment. SBRT was delivered to a peripheral dose of 16 to 24 grays in a single fraction while limiting the dose to the spinal cord. Higher doses were used for renal cell histology. The National Cancer Institute Common Toxicity Criteria 2.0 and McCormick neurologic function score were used as toxicity assessment tools.

resultsIn total, 61 patients who had 63 tumors of the noncervical spine were enrolled and received SBRT between 2005 and 2010 on a prospective, phase 1/2 trial at The University of Texas M. D. Anderson Cancer Center. The mean follow-up was 20 months. The actuarial 18-month imaging local control rate for all patients was 88%, the actuarial 18-month overall survival rate for all patients was 64%, and the median survival for all patients was 30 months. No significant differences in outcomes were noted with respect to tumor histology or SBRT dose. Two patients experienced radiation adverse events (grade 3 or higher). The actuarial rate of 18-month freedom from neurologic deterioration from any cause was 82%.

conclusionsData from this phase 1/2 trial supported an expanded indication for SBRT as first-line treatment of spinal metastases in selected patients. The authors concluded that additional studies that can prospectively identify predictive factors for spinal cord toxicity after SBRT are warranted to minimize the incidence of this serious yet rare complication.

Indexed as

AdultAgedFemaleHumansMiddle AgedNeoplasm Recurrence, LocalRadiosurgeryRadiotherapy DosageSpinal Neoplasms

Identifiers

PMID22511344
PMCPMC3635840
OpenAlexW1589157904

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.