Evidence map›Paper›PMID 33203426›Full record

ArticleBMC cancer2020

Early palliative radiation versus observation for high-risk asymptomatic or minimally symptomatic bone metastases: study protocol for a randomized controlled trial.

Daniel B Rosen, Cory D Benjamin, Joanna C Yang, Connor Doyle, Zhigang Zhang, Chris A Barker, Max Vaynrub, T Jonathan Yang, Erin F Gillespie

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

Article in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03523351 (A Randomized Trial of Early, Upfront Palliative Radiation Therapy Versus Standard of Care for Patients With Highest Risk Asymptomatic or Minimally Symptomatic Bone Metastases), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.5field-weighted citation impact, top 10% 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.

NCT03523351 phase1 / phase2completednot on this map

A Randomized Trial of Early, Upfront Palliative Radiation Therapy Versus Standard of Care for Patients With Highest Risk Asymptomatic or Minimally Symptomatic Bone Metastases

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2018 to 2024Enrolled78ConditionsMetastatic Solid Tumors of Metastatic DiseaseArmsRadiation Therapy, Systemic Therapy
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 21 citations in OpenAlex.

  1. Evaluating risk factors for skeletal-related events among bone metastases from solid tumors.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2025
    Article
  2. Article
  3. Reply to A.W. Chan et al.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Article
  4. An Update on the Management of Bone Metastases.Current oncology reports · 2024
    Review
  5. [Prophylactic Radiation Therapy Versus Standard of Care for Patients With High-Risk Asymptomatic Bone Metastases].Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2024
    Article
  6. Review
  7. 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

9 authors at 1 institution in 1 country.

Daniel B RosenDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, Box 22, New York, NY, 10065, USA.
Cory D BenjaminDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, Box 22, New York, NY, 10065, USA.
Joanna C YangDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, Box 22, New York, NY, 10065, USA.
Connor DoyleDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, Box 22, New York, NY, 10065, USA.
Zhigang ZhangDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Chris A BarkerDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, Box 22, New York, NY, 10065, USA.
Max VaynrubDepartment of Surgery, Orthopaedic Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
T Jonathan YangDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, Box 22, New York, NY, 10065, USA. yangt@mskcc.org.
Erin F GillespieDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, Box 22, New York, NY, 10065, USA. efgillespie@ucsd.edu.ORCID http://orcid.org/0000-0002-1386-1542
Memorial Sloan Kettering Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Weill Cornell/Rockefeller/Sloan-Kettering MST ProgramT32GM007739 · NIGMS · WEILL MEDICAL COLL OF CORNELL UNIV · PI HSU, KATHARINE C · 1985 to 2023
$51.1M
NCI NIH HHS P30 CA008748NIGMS NIH HHS T32 GM007739NIGMS NIH HHS T32GM007739
6 · The paper itself

Abstract

backgroundIn patients with metastatic cancer, the bone is the third-most common site of involvement. Radiation to painful bone metastases results in high rates of pain control and is an integral part of bone metastases management. Up to one-third of inpatient consults are requested for painful bone metastases, and up to 60% of these patients had evidence of these lesions visible on prior imaging. Meanwhile recent advances have reduced potential side effects of radiation. Therefore, there is an opportunity to further improve outcomes for patients using prophylactic palliative radiation to manage asymptomatic bone metastases. METHODS/STUDY

designIn this trial, 74 patients with metastatic solid tumors and high-risk asymptomatic or minimally symptomatic bone metastases will be enrolled and randomized to early palliative radiation or standard of care. This will be the first trial to assess the efficacy of prophylactic palliative radiation in preventing skeletal related events (SREs), the primary endpoint. This endpoint was selected to encompass patient-centered outcomes that impact quality of life including pathologic fracture, spinal cord compression, and intervention with surgery or radiation. Secondary endpoints include hospitalizations, Bone Pain Index, pain-free survival, pain-related quality of life, and side effects of radiation therapy. DISCUSSION: In this study, we propose a novel definition of high-risk bone metastases most likely to benefit from preventive radiation and use validated questionnaires to assess pain and impact on quality of life and health resource utilization. Observations from early patient enrollment have demonstrated robustness of the primary endpoint and need for minor modifications to Bone Pain Index and data collection for opioid use and hospitalizations. With increasing indications for radiation in the oligometastatic setting, this trial aims to improve patient-centered outcomes in the polymetastatic setting.

trial registrationISRCTN Number/Clinical trials.gov, ID: NCT03523351 . Registered on 14 May 2018.

Indexed as

Palliative CareAdolescentAdultAgedAged, 80 and overBone NeoplasmsClinical Trials, Phase II as TopicFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasmsObservational Studies as TopicPrognosisProspective StudiesBone metastasisPatient-centered outcomesRadiation therapySkeletal-related events (SRE)

Identifiers

PMID33203426
PMCPMC7670812
OpenAlexW3100786207

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.