Evidence map›Paper›PMID 32251755›Full record

Trial reportInternational journal of radiation oncology, biology, physics2020

Phase 2 Study of a Temozolomide-Based Chemoradiation Therapy Regimen for High-Risk, Low-Grade Gliomas: Long-Term Results of Radiation Therapy Oncology Group 0424.

Barbara J Fisher, Stephanie L Pugh, David R Macdonald, Arnab Chakravatri, Glenn J Lesser, Sherry Fox, C Leland Rogers, Maria Werner-Wasik, Thomas Doyle, Jean-Paul Bahary and 12 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
–field-weighted citation impact
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

35 citing papers in PubMed.

  1. Trial
  2. Review
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  7. Observational
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  9. Article
  10. Review
  11. Review
  12. Review
  13. Article
  14. Multidisciplinary Management of Isocitrate Dehydrogenase-Mutated Gliomas in a Contemporary Molecularly Defined Era.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Review
  15. Article
  16. Article
  17. Article
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  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors.

Barbara J FisherLondon Regional Cancer Program, London, Ontario, Canada. Electronic address: barbara.fisher@lhsc.on.ca.
Stephanie L PughNRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
David R MacdonaldLondon Regional Cancer Program, London, Ontario, Canada.
Arnab ChakravatriOhio State University Comprehensive Cancer Center, Columbus, Ohio.
Glenn J LesserComprehensive Cancer Center of Wake Forest University, Winston-Salem, North Carolina.
Sherry FoxCullather Brain Tumor Quality of Life Center, Richmond, Virginia.
C Leland RogersArizona Oncology Services Foundation, Scottsdale, Arizona.
Maria Werner-WasikThomas Jefferson University Hospital, Philadelphia, Pennsylvania.
Thomas DoyleHenry Ford Hospital, Detriot, Michigan.
Jean-Paul BaharyCentre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada.
John B FiveashUniversity of Alabama at Birmingham Medical Center, Birmingham, Alabama.
Joseph A BoviFroedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin.
Steven P HowardUniversity of Wisconsin Hospital, Madison, Wisconsin.
Hsiang-Hsuan Michael YuH. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
David D'SouzaLondon Regional Cancer Program, London, Ontario, Canada.
Nadia N LaackMayo Clinic, Rochester, Minnesota.
Igor J BaraniUCSF Medical Center - Mount Zion, San Francisco, California.
Young KwokUniversity of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, Baltimore, Maryland.
Daniel R WahlUniversity of Michigan Medical Center, Ann Arbor, Michigan.
Jon F StrasserChristiana Care Health Services, Inc, Wilmington, Delaware.
Minhee WonNRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
Minesh P MehtaMiami Cancer Institute, Kendall, Florida.

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Mei-Yin C Polley · 2014 to 2026
$146.4M
NRG Oncology Biospecimen BankU24CA196067 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Tanner J. Freeman, Nilsa Del Carmen Ramirez Milan · 2015 to 2026
$42.6M
NCTN Deep South Research ConsortiumUG1CA233330 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Charles A. Leath, Andrew M McDonald · 2019 to 2026
$3.7M
NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA196067NCI NIH HHS UG1 CA233330
6 · The paper itself

Abstract

purposeTo report the long-term outcomes of the RTOG 0424 study of a high-risk, low-grade glioma population treated with concurrent and adjuvant temozolomide (TMZ) and radiation therapy (RT). METHODS AND MATERIALS: For this single-arm, phase 2 study, patients with low-grade gliomas with ≥3 risk factors (age ≥40 years, astrocytoma, bihemispheric tumor, size ≥6 cm, or preoperative neurologic function status >1) received RT (54 Gy in 30 fractions) with TMZ and up to 12 cycles of post-RT TMZ. The initial primary endpoint P was overall survival (OS) at 3 years after registration. Secondary endpoints included progression-free survival (PFS) and the association of survival outcomes with methylation status. The initial 3-year report of this study was published in 2015.

resultsThe study accrued 136 patients, of whom 129 were analyzable. The median follow-up for surviving patients was 9.0 years. The 3-year OS was 73.5% (95% confidence interval, 65.8%-81.1%), numerically superior to the 3-year OS historical control of 54% (P < .001). The median survival time was 8.2 years (95% confidence interval, 5.6-9.1). Five- and 10-year OS rates were 60.9% and 34.6%, respectively, and 5- and 10-year PFS rates were 46.8% and 25.5%, respectively.

conclusionsThe long-term results confirmed the findings from the initial report for efficacy, suggesting OS and PFS outcomes with the RT-TMZ regimen exceeded historical control groups treated with radiation alone. Toxicity was acceptable.

Indexed as

ChemoradiotherapyAdultBrain NeoplasmsFemaleGliomaHumansKaplan-Meier EstimateMaleNeoplasm GradingProgression-Free SurvivalTemozolomideTemozolomide

Identifiers

PMID32251755
PMCPMC7456814

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.