Evidence map›Paper›PMID 30094545›Full record

Trial reportAnnals of nuclear medicine2018

Randomized phase III trial to evaluate radiopharmaceuticals and zoledronic acid in the palliation of osteoblastic metastases from lung, breast, and prostate cancer: report of the NRG Oncology RTOG 0517 trial.

Michael J Seider, Stephanie L Pugh, Corey Langer, Gwen Wyatt, William Demas, Afshin Rashtian, Cathy L Clausen, Jerome David Derdel, Sean F Cleary, Christopher A Peters and 7 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Annals of nuclear medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00365105 (Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer), which is not on this map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 3 pooled it
0.5field-weighted citation impact, top 31% 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.

NCT00365105 phase3completednot on this map

Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer

TypeinterventionalSponsorRadiation Therapy Oncology GroupRan2006 to 2017Enrolled261ConditionsBreast Cancer, Lung Cancer, Metastatic Cancer, PainArmsCalcium, Vitamin D, zoledronic acid, Sm-153, Sr-89
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 3 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Interventional Therapies to Treat Cancer Associated Pain.Current treatment options in oncology · 2025
    Review
  5. Emerging treatment options for prostate cancer.Expert review of anticancer therapy · 2023
    Review
  6. Review
  7. Review
  8. Review
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

17 authors at 13 institutions in 2 countries.

Michael J Seider, Cleveland, OH, USA. seider1951@yahoo.com.
Stephanie L PughNRG Oncology Statistics and Data Management Center, Philadelphia, PA, USA.
Corey LangerUniversity of Pennsylvania, Philadelphia, PA, USA.
Gwen WyattMichigan State University, East Lansing, MI, USA.
William DemasSalem Regional Medical Center, Salem, OH, USA.
Afshin RashtianUniversity of Southern California-Los Angeles, Los Angeles, CA, USA.
Cathy L ClausenSt Johns Hospital Cancer Institute, Springfield, IL, USA.
Jerome David DerdelMount Nittany Medical Center Penn State Cancer Institute, State College, PA, USA.
Sean F ClearyYakima Valley Memorial Hospital, Yakima, WA, USA.
Christopher A PetersNortheast Radiation Oncology Center, Scranton, PA, USA.
Ashok RamalingamUniversity Hospitals of Cleveland, Cleveland, OH, USA.
James E ClarksonSinging River Hospital Regional Cancer Center, Pascagoula, MS, USA.
Michael TomblynUniversity of South Florida Morsani School of Medicine, Tampa, FL, USA.
Rachel A RabinovitchUniversity of Colorado Denver, Denver, CO, USA.
Lisa A KachnicBoston Medical Center MBCCOP, Boston, MA, USA.
Lawrence B BerkTampa General Hospital, Tampa, FL, USA.
NRG Oncology
Mount Nittany Medical Center · USUniversity Hospitals of Cleveland · USUniversity of Southern California · USBoston Medical Center · USBoston University · USNRG Oncology · USRegional Medical Center · USTampa General Hospital · USUniversity of Denver · USUniversity of Pennsylvania · USUniversity of South Florida · USVirginia Mason Memorial · USYahoo (United Kingdom) · GB

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
RTOG Foreign AccrualU10CA021661 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI CURRAN, WALTER J. · 1985 to 2013
$150.3M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Mei-Yin C Polley · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
RTOG Foreign AccrualsU10CA037422 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI BRUNER, DEBORAH WATKINS · 1985 to 2013
$30.4M
NCI National Clinical Trials Network - Lead Academic Participating SiteUG1CA233324 · NCI · UNIVERSITY OF COLORADO DENVER · PI ANTHONY D ELIAS · 2019 to 2026
$5.2M
University of Colorado NTCN Lead Academic Participating Site (LAPS) U10CA180834 · NCI · UNIVERSITY OF COLORADO DENVER · PI ELIAS, ANTHONY D · 2014 to 2018
$3.8M
NCI NIH HHS U10 CA021661NCI NIH HHS U10 CA037422NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180834NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA21661NCI NIH HHS U10 CA37422NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA233324
6 · The paper itself

Abstract

backgroundSkeletal-related events (SREs), common sequelae of metastatic cancer, are reduced by bisphosphonates. In this study, it was postulated that radiopharmaceuticals, added to bisphosphonates, could further decrease the incidence of SREs.

methodsNRG Oncology RTOG 0517 randomized patients with breast, lung, and prostate cancer and blastic bone metastases to either zoledronic acid (ZA) alone or ZA plus radiopharmaceuticals (Sr-89 or Sm-153). The primary endpoint was time to development of SREs. Secondary objectives included quality of life (QOL), pain control, overall survival (OS), and toxicity.

results261 patients (median age 68; 62% male; 55% prostate, 35% breast, 10% lung) were accrued between July 2006 and February 2011. The study closed early due to a lower than expected rate of SREs. 52 (42%) patients in the ZA arm and 49 (40%) in the radiopharmaceutical arm experienced an SRE. Median time free of SREs was 29.9 and 27.4 months, respectively (p = 0.84). Median OS in the ZA arm and radiopharmaceutical arms was 32.1 and 26.9 months, respectively (p = 0.37). Cox proportional hazards regression model showed that primary disease site (lung) and number of bone metastases (> 2) had a negative impact on OS (p < 0.0001, p = 0.01, respectively). The addition of radiopharmaceuticals to ZA led to a significant reduction in pain at 1 month based on BPI worst score (p = 0.02). No other group differences were noted for QOL or toxicity.

conclusionThe addition of radiopharmaceuticals to bisphosphonates did not alter time to SREs or OS for patients with breast, lung, prostate cancers and blastic bone metastases, although it was associated with significant pain reduction at 1 month. CLINICAL TRIAL REGISTRY: This protocol (RTOG 0517) is registered with ClinicalTrials.gov (NCT00365105), and may be viewed online at http://www.clinicaltrials.gov/ct2/show/NCT00365105?term=RTOG+0517&rank=1 .

Indexed as

AdultAgedAged, 80 and overBone NeoplasmsBreast NeoplasmsDiphosphonatesFemaleHumansImidazolesLung NeoplasmsMaleMiddle AgedOsteoblastsPalliative CareProstatic NeoplasmsQuality of LifeDiphosphonatesImidazolesRadiopharmaceuticalsZoledronic Acid

Identifiers

PMID30094545
PMCPMC6245542
OpenAlexW2887812702

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.