Evidence map›Paper›PMID 26829933›Full record

Trial reportTrials2016

Stereotactic versus conventional radiotherapy for pain reduction and quality of life in spinal metastases: study protocol for a randomized controlled trial.

Pètra Braam, Philippe Lambin, Johan Bussink

3 registry-linked trialsOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 12% 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.

NCT02407795 naterminatednot on this map

A RAndomized Trial Comparing COnventional With STereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases (RACOST-trial)

TypeinterventionalSponsorRadboud University Medical CenterRan2015 to 2021Enrolled25ConditionsSpinal MetastasesArmsconventional radiotherapy, stereotactic radiotherapy
NCT03554135 unknown statusnot on this mapstarted 2018, after this paper: background citation

SAINT: Single frActIoN eighT Gray Palliative Radiotherapy With Modulated Intensity for Pain Reduction: a Single Arm Cohort Analysis

Typeobservational_patient_registrySponsorFondazione Policlinico Universitario Agostino Gemelli IRCCSRan2018 to 2019Enrolled50ConditionsBone Metastases, Radiotherapy, TechnologyArmsPersonalization of palliative radiotherapy
NCT03597984 naunknown statusnot on this mapstarted 2019, after this paper: background citation

PREST: Pain REduction With Bone Metastases STereotactic Radiotherapy: A Phase III Randomized Multicentric Trial

TypeinterventionalSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCSRan2019 to 2020Enrolled330ConditionsBone Metastases, Radiotherapy, TechnologyArmsSimultaneous Integrated Boost-SIB on macroscopic metastases
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Palliative radiotherapy.BMJ (Clinical research ed.) · 2018
    Review
  6. 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

3 authors at 2 institutions in 2 countries.

Pètra BraamDepartment of Radiation Oncology, Radboud University Medical Center Nijmegen, Geert Grooteplein-Zuid 32, route 874, PB 9101, Nijmegen, GA, 6525, The Netherlands. p.braam@radboudumc.nl.
Philippe LambinMAASTRO Clinic, Doctor Tanslaan 12, 6229 ET, Maastricht, The Netherlands. philippe.lambin@maastro.nl.
Johan BussinkDepartment of Radiation Oncology, Radboud University Medical Center Nijmegen, Geert Grooteplein-Zuid 32, route 874, PB 9101, Nijmegen, GA, 6525, The Netherlands. jan.bussink@radboudumc.nl.
Radboud University Medical Center · NLMaastro Clinic · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPainful spinal metastases have been treated with conventional radiotherapy for decades, but one-third of the patients have insufficient pain relief after treatment and one-fifth need retreatment. Stereotactic radiotherapy is a method to increase the dose in the spinal metastases with a potentially longer lasting palliative effect without increasing the side effects of the treatment and thereby is expected to improve the quality of life significantly. METHODS/

designThis study is a multicenter prospective randomized clinical trial comparing conventional radiotherapy (1 x 8 Gy) with stereotactic radiotherapy (1 x 20 Gy) for pain reduction and quality of life in patients with painful spinal metastases. A total of 386 patients will be randomized between the two treatment groups. Besides pain measured by the Dutch Brief Pain Inventory, quality of life and cost-effectiveness also will be measured. The primary outcome is pain reduction at 6 weeks after treatment. Secondary outcomes will be the time to pain response, duration of pain relief, health-related quality of life and toxicity, as well as cost-effectiveness. DISCUSSION: This study investigates whether stereotactic radiotherapy with dose escalation for symptomatic spinal metastases can lead to improved pain reduction as compared to conventional radiotherapy without an increase of treatment-related side effects. These results will contribute to the optimization and individualization of the treatment for the patient.

trial registrationClinicalTrials.gov identifier NCT02407795 (March 31, 2015).

Indexed as

Clinical ProtocolsQuality of LifeCost-Benefit AnalysisEndpoint DeterminationHumansIntractable PainOutcome Assessment, Health CarePalliative CarePatient SelectionProspective StudiesRadiosurgerySpinal Neoplasms

Identifiers

PMID26829933
PMCPMC4735957
OpenAlexW2255846762

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.