Evidence map›Paper›PMID 31013172›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Randomized Double-Blind Phase II Study of Regorafenib in Patients With Metastatic Osteosarcoma.

Lara E Davis, Vanessa Bolejack, Christopher W Ryan, Kristen N Ganjoo, Elizabeth T Loggers, Sant Chawla, Mark Agulnik, Michael B Livingston, Damon Reed, Vicky Keedy and 7 more

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

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05395741 (Evaluation of the Efficacy and Safety of Regorafenib in Patients With Refractory Primary Bone Tumors), which is not on this map. Cited by 149 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
149citing papers in PubMed, 5 pooled it
21.8field-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.

NCT05395741 phase1 / phase2completednot on this mapstarted 2022, after this paper: background citation

Evaluation of the Efficacy and Safety of Regorafenib in Patients With Refractory Primary Bone Tumors

TypeinterventionalSponsorInstitute of Mother and Child, Warsaw, PolandRan2022 to 2026Enrolled30ConditionsOsteosarcoma, Ewing Sarcoma of BoneArmsRegorafenib
3 · Its place in the literature

Who cites it

149 citing papers in PubMed, 5 syntheses or guidelines pooled it, 254 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. [Update and interpretation of 2021 National Comprehensive Cancer Network (NCCN) "Clinical Practice Guidelines for Bone Tumors"].Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery · 2021
    Guideline
  4. Pooled it
  5. Pooled it
  6. Trial
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  20. What's new in pediatric bone sarcomas and benign bone tumors.Journal of children's orthopaedics · 2026
    Article

89 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

17 authors at 16 institutions in 1 country.

Lara E Davis1 Knight Cancer Institute, Oregon Health & Science University, Portland, OR.
Vanessa Bolejack2 Cancer Research and Biostatistics, Seattle, WA.
Christopher W Ryan1 Knight Cancer Institute, Oregon Health & Science University, Portland, OR.
Kristen N Ganjoo3 Stanford Cancer Institute, Stanford, CA.
Elizabeth T Loggers4 Fred Hutchinson Cancer Research Center, Seattle, WA.
Sant Chawla5 Sarcoma Oncology Research Center, Santa Monica, CA.
Mark Agulnik6 Northwestern University, Chicago, IL.
Michael B Livingston7 Levine Cancer Institute, Charlotte, NC.
Damon Reed8 H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Vicky Keedy9 Vanderbilt-Ingram Cancer Center, Nashville, TN.
Daniel Rushing10 Indiana University, Bloomington, IN.
Scott Okuno11 Mayo Clinic Rochester, Rochester, MN.
Denise K Reinke12 Sarcoma Alliance for Research Through Collaboration, Ann Arbor, MI.
Richard F Riedel13 Duke Cancer Institute, Duke University Medical Center, Durham, NC.
Steven Attia14 Mayo Clinic Jacksonville, Jacksonville, FL.
Leo Mascarenhas15 Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, CA.
Robert G Maki16 Monter Cancer Center, Northwell Health, Lake Success, NY, and Cold Spring Harbor Laboratory, Cold Spring Harbor, NY.
Oregon Health & Science University · USCancer Research And Biostatistics · USDuke Medical Center · USFred Hutch Cancer Center · USIndiana University Bloomington · USLevine Cancer Institute · USMayo Clinic in Florida · USMoffitt Cancer Center · USNorthwell Health · USNorthwestern University · USSarcoma Alliance for Research through Collaboration · USSarcoma Oncology Center · USStanford Cancer InstituteUniversity of Southern California · USVanderbilt University · USWinnMed · US

Funding

USC/NORRIS COMPREHENSIVE CANCER CENTER (CORE) SUPPORTP30CA014089 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI MYLES G COCKBURN · 1985 to 2026
$181.4M
TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI Christine O'Connell · 1998 to 2026
$93.5M
NCI NIH HHS P30 CA014089NCI NIH HHS P30 CA076292
6 · The paper itself

Abstract

purposeSARC024 is a phase II clinical trial of the multikinase inhibitor regorafenib in specific sarcoma subtypes, including advanced osteosarcoma. We hypothesized that regorafenib would improve progression-free survival (PFS) in patients with sarcoma and report the results of the osteosarcoma cohort. PATIENTS AND

methodsThis trial enrolled patients with progressive metastatic osteosarcoma with measurable disease by RECIST who had received at least one prior line of therapy. Patients were randomly assigned at a ratio of one to one to regorafenib or placebo. Crossover was allowed at time of disease progression. PFS was the primary end point of the study, which was powered to detect a difference of at least 3 months in median PFS.

resultsForty-two patients from 12 centers were enrolled between September 2014 and May 2018. Median age was 37 years (range, 18 to 76 years). Patients had received an average of 2.3 prior therapy regimens. Ten patients receiving placebo crossed over to active drug at time of progression. Study enrollment was stopped early, after a data safety monitoring committee review. Median PFS was significantly improved with regorafenib versus placebo: 3.6 months (95% CI, 2.0 to 7.6 months) versus 1.7 months (95% CI, 1.2 to 1.8 months), respectively (hazard ratio, 0.42; 95% CI, 0.21 to 0.85;

conclusionThe study met its primary end point, demonstrating activity of regorafenib in patients with progressive metastatic osteosarcoma. No new safety signals were observed. Regorafenib should be considered a treatment option for patients with relapsed metastatic osteosarcoma.

Indexed as

AdolescentAdultAgedAntineoplastic AgentsBone NeoplasmsCross-Over StudiesDisease ProgressionDouble-Blind MethodFemaleHumansMaleMiddle AgedOsteosarcomaPhenylurea CompoundsProgression-Free SurvivalProtein Kinase InhibitorsAntineoplastic AgentsPhenylurea CompoundsProtein Kinase InhibitorsPyridinesregorafenib

Identifiers

PMID31013172
PMCPMC7799443
OpenAlexW2941090871

What OpenQuestion holds

Textmetadata
LicenceTDM
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.