Evidence map›Paper›PMID 25680596›Full record

Trial reportInternational journal of radiation oncology, biology, physics2015

Phase 2 study of temozolomide-based chemoradiation therapy for high-risk low-grade gliomas: preliminary results of Radiation Therapy Oncology Group 0424.

Barbara J Fisher, Chen Hu, David R Macdonald, Glenn J Lesser, Stephen W Coons, David G Brachman, Samuel Ryu, Maria Werner-Wasik, Jean-Paul Bahary, Junfeng Liu and 2 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 73 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed, 2 pooled it
11.8field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

73 citing papers in PubMed, 2 syntheses or guidelines pooled it, 161 citations in OpenAlex.

  1. Pooled it
  2. SEOM clinical guideline of diagnosis and management of low-grade glioma (2017).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2018
    Guideline
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Chemotherapy in pediatric low-grade gliomas (PLGG).Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2024
    Review
  17. Review
  18. Article
  19. Article
  20. Article

13 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

12 authors at 11 institutions in 3 countries.

Barbara J FisherLondon Regional Cancer Program, London, Ontario, Canada. Electronic address: barbara.fisher@lhsc.on.ca.
Chen HuRadiation Therapy Oncology Group-Statistical Center, Philadelphia, Pennsylvania.
David R MacdonaldLondon Regional Cancer Program, London, Ontario, Canada.
Glenn J LesserWake Forest University Baptist Medical Center, Winston-Salem, North Carolina.
Stephen W CoonsBarrow Neurological Institute, Phoenix, Arizona.
David G BrachmanArizona Oncology Services Foundation, Phoenix, Arizona.
Samuel RyuHenry Ford Hospital, Detroit, Michigan.
Maria Werner-WasikThomas Jefferson University Hospital Center, Philadelphia, Pennsylvania.
Jean-Paul BaharyCentre Hospitalier de l'Université de Montréal-Notre Dame, Montreal, Quebec, Canada.
Junfeng LiuGCE Solutions, Inc., Bloomington, Illinois.
Arnab ChakravartiThe Ohio State University, The James, Columbus, Ohio.
Minesh MehtaUniversity of Maryland Medical Systems, Baltimore, Maryland.
Arizona Oncology · USAtrium Health Wake Forest Baptist · USBarrow Neurological Institute · USGCE Lab School · USHenry Ford Hospital · USHôpital Notre-Dame · CALondon Cancer · GBRTOG Foundation · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · USThomas Jefferson University Hospital · USUniversity of Maryland, Baltimore · US

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
IROC: Enhancing local enrolling site radiological data capture capabilities for NCTN trialsU24CA180803 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI Thomas J. FitzGerald, MICHAEL V KNOPP · 2014 to 2026
$116.2M
RTOG Foreign AccrualsU10CA037422 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI BRUNER, DEBORAH WATKINS · 1985 to 2013
$30.4M
OSU as Network Lead Academic Participating Site for the NCI NCTNU10CA180850 · NCI · OHIO STATE UNIVERSITY · PI BLUM, KRISTIE A, CHAKRAVARTI, ARNAB · 2014 to 2018
$6.8M
NCI NIH HHS U10 CA021661NCI NIH HHS U10 CA037422NCI NIH HHS U10 CA180822NCI NIH HHS U10CA180822NCI NIH HHS U10 CA180850NCI NIH HHS U10 CA180868NCI NIH HHS U10CA180868NCI NIH HHS U10CA21661NCI NIH HHS U10CA37422NCI NIH HHS U24 CA180803NCI NIH HHS U24CA180803NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

purposeRadiation Therapy Oncology Group (RTOG) 0424 was a phase 2 study of a high-risk low-grade glioma (LGG) population who were treated with temozolomide (TMZ) and radiation therapy (RT), and outcomes were compared to those of historical controls. This study was designed to detect a 43% increase in median survival time (MST) from 40.5 to 57.9 months and a 20% improvement in 3-year overall survival (OS) rate from 54% to 65% at a 10% significance level (1-sided) and 96% power. METHODS AND MATERIALS: Patients with LGGs with 3 or more risk factors for recurrence (age ≥40 years, astrocytoma histology, bihemispherical tumor, preoperative tumor diameter of ≥6 cm, or a preoperative neurological function status of >1) were treated with RT (54 Gy in 30 fractions) and concurrent and adjuvant TMZ.

resultsFrom 2005 to 2009, 129 evaluable patients (75 males and 54 females) were accrued. Median age was 49 years; 91% had a Zubrod score of 0 or 1; and 69%, 25%, and 6% of patients had 3, 4, and 5 risk factors, respectively. Patients had median and minimum follow-up examinations of 4.1 years and 3 years, respectively. The 3-year OS rate was 73.1% (95% confidence interval: 65.3%-80.8%), which was significantly improved compared to that of prespecified historical control values (P<.001). Median survival time has not yet been reached. Three-year progression-free survival was 59.2%. Grades 3 and 4 adverse events occurred in 43% and 10% of patients, respectively. One patient died of herpes encephalitis.

conclusionsThe 3-year OS rate of 73.1% for RTOG 0424 high-risk LGG patients is higher than that reported for historical controls (P<.001) and the study-hypothesized rate of 65%.

Indexed as

AdultAgedAntineoplastic Agents, AlkylatingBrain NeoplasmsChemoradiotherapyDacarbazineDisease-Free SurvivalDose Fractionation, RadiationFemaleGliomaHumansMaleMiddle AgedRadiotherapy, ConformalResearch DesignRisk FactorsAntineoplastic Agents, AlkylatingDacarbazineTemozolomide

Identifiers

PMID25680596
PMCPMC4329190
OpenAlexW2023179262

What OpenQuestion holds

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Registered trials

None linked

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.