Evidence map›Paper›PMID 31484505›Full record

ArticleBMC cancer2019

A phase III randomized-controlled, single-blind trial to improve quality of life with stereotactic body radiotherapy for patients with painful bone metastases (ROBOMET).

Carole Mercier, Piet Dirix, Piet Ost, Charlotte Billiet, Ines Joye, Peter Vermeulen, Yolande Lievens, Dirk Verellen

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03831243 (A Phase III Randomized-controlled, Single-blind Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.2field-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.

NCT03831243 nacompletednot on this map

A Phase III Randomized-controlled, Single-blind Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases

TypeinterventionalSponsorCancer Research AntwerpRan2019 to 2023Enrolled126ConditionsMetastasis to Bone, Radiotherapy, Neoplasm MetastasisArmsStereotactic body radiotherapy, 3D-conformal radiotherapy
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 21 citations in OpenAlex.

  1. Article
  2. An Update on the Management of Bone Metastases.Current oncology reports · 2024
    Review
  3. Article
  4. Article
  5. Quality of life improvement in patients with bone metastases undergoing palliative radiotherapy.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2022
    Article
  6. Using a Chinese time trade-off approach to explore the health utility level and quality of life of cancer patients in urban China: a multicentre cross-sectional study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
    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

8 authors at 3 institutions in 1 country.

Carole MercierDepartment of Radiation Oncology, Iridium Kankernetwerk, Oosterveldlaan 22, Wilrijk, B-2610, Antwerp, Belgium. carole.mercier@gza.be.ORCID http://orcid.org/0000-0002-0427-8371
Piet DirixDepartment of Radiation Oncology, Iridium Kankernetwerk, Oosterveldlaan 22, Wilrijk, B-2610, Antwerp, Belgium.
Piet OstDepartment of Radiotherapy, Ghent University Hospital, Ghent, Belgium.
Charlotte BillietDepartment of Radiation Oncology, Iridium Kankernetwerk, Oosterveldlaan 22, Wilrijk, B-2610, Antwerp, Belgium.
Ines JoyeDepartment of Radiation Oncology, Iridium Kankernetwerk, Oosterveldlaan 22, Wilrijk, B-2610, Antwerp, Belgium.
Peter VermeulenMolecular Imaging, Pathology, Radiotherapy & Oncology (MIPRO), University of Antwerp, Edegem, Antwerp, Belgium.
Yolande LievensDepartment of Radiotherapy, Ghent University Hospital, Ghent, Belgium.
Dirk VerellenDepartment of Radiation Oncology, Iridium Kankernetwerk, Oosterveldlaan 22, Wilrijk, B-2610, Antwerp, Belgium.
University of Antwerp · BEGhent University Hospital · BEVrije Universiteit Brussel · BE

Funding

Kom op tegen Kanker 00000000010000000327
6 · The paper itself

Abstract

backgroundBone metastases represent an important source of morbidity in cancer patients, mostly due to severe pain. Radiotherapy is an established symptomatic treatment for painful bone metastases, however, when conventional techniques are used, the effectiveness is moderate. Stereotactic body radiotherapy (SBRT), delivering very high doses in a limited number of fractions in a highly conformal manner, could potentially be more effective and less toxic.

methodsThis is a phase III, randomized-controlled, single-blind, multicenter study evaluating the response rate of antalgic radiotherapy for painful bone metastases and the acute toxicity associated with this treatment. A total of 126 patients will be randomly assigned to receive either the standard schedule of a single fraction of 8.0 Gy delivered through three-dimensional conformal radiotherapy or a single fraction of 20.0 Gy delivered through SBRT. Primary endpoint is pain response at the treated site at 1 month after radiotherapy. Secondary endpoints are pain flare at 24-48-72 h after radiotherapy, duration of pain response, re-irradiation need, acute toxicity, late toxicity, quality of life and subsequent serious skeletal events. In a supplementary analysis, patient-compliance for a paper-and-pencil questionnaire will be compared with an electronic mode. DISCUSSION: If a dose-escalated approach within the context of single fraction stereotactic body radiotherapy could improve the pain response to radiotherapy and minimize acute toxicity, this would have an immediate impact on the quality of life for a large number of patients with advanced cancer. Potential disadvantages of this technique include increased pain flare or a higher incidence of radiation-induced fractures.

trial registrationThe Ethics committee of the GZA Hospitals (B099201732915) approved this study on September 4th 2018. Trial registered on Clinicaltrials.gov ( NCT03831243 ) on February 5th 2019.

Indexed as

Radiotherapy, ConformalBone NeoplasmsCancer PainClinical Trials as TopicHumansPain MeasurementQuality of LifeRadiosurgeryRadiotherapy DosageSingle-Blind MethodBone metastasesPainSpinal metastasesStereotactic body radiotherapy

Identifiers

PMID31484505
PMCPMC6727408
OpenAlexW2972210310

What OpenQuestion holds

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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.