Evidence map›Paper›PMID 34406870›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Randomized Phase III Trial Evaluating Radiation Following Surgical Excision for Good-Risk Ductal Carcinoma In Situ: Long-Term Report From NRG Oncology/RTOG 9804.

Beryl McCormick, Kathryn A Winter, Wendy Woodward, Henry M Kuerer, Nour Sneige, Eileen Rakovitch, Barbara L Smith, Isabelle Germain, Alan C Hartford, Mark A O'Rourke and 9 more

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

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05637216 (A Pilot Study of Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients), which is not on this map. Cited by 44 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 3 pooled it
6.6field-weighted citation impact, top 2% 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.

NCT05637216 phase2active not recruitingnot on this mapstarted 2023, after this paper: background citation

A Pilot Study of Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients

TypeinterventionalSponsorShaw Cancer CenterRan2023 to 2027Enrolled43ConditionsRadiation Induced FibrosisArmsLosartan 25 milligram capsule, Placebo
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 3 syntheses or guidelines pooled it, 95 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Article
  7. Article
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  11. Article
  12. Lumpectomy surgery for large ductal carcinoma in situ.Breast cancer research and treatment · 2025
    Article
  13. Should All Low-Grade Ductal CarcinomaWorld journal of oncology · 2025
    Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 12 institutions in 2 countries.

Beryl McCormickMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-4550-0565
Kathryn A WinterNRG Oncology Statistics and Data Management Center, Philadelphia, PA.
Wendy WoodwardThe University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-7935-739X
Henry M KuererThe University of Texas MD Anderson Cancer Center, Houston, TX.
Nour SneigeThe University of Texas MD Anderson Cancer Center, Houston, TX.
Eileen RakovitchOdette Cancer Centre-Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
Barbara L SmithMassachusetts General Hospital Cancer Center, Boston, MA.ORCID 0000-0003-4281-665X
Isabelle GermainCHU de Quebec-L'Hotel-Dieu de Quebec, Quebec City, QC, Canada.
Alan C HartfordDartmouth-Hitchcock Medical Center, Lebanon, NH.
Mark A O'RourkeGreenville CCOP-Cancer Centers of The Carolinas-Eastside, Greenville, SC.ORCID 0000-0003-1707-6186
Eleanor M WalkerHenry Ford Hospital Rogel Cancer Center, Detroit, MI.
Eric A StromThe University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0003-4542-9575
Judith O HopkinsSoutheast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem, NC.
Lori J PierceUniversity of Michigan, Ann Arbor, MI.ORCID 0000-0002-3734-5710
Anthony T PuRadiological Associates of Sacramento, Sacramento, CA.ORCID 0000-0002-6579-7474
Kenneth N M SumidaUniversity of Hawaii Cancer Center MBCCOP, Honolulu, HI.
Danny VespriniOhio State University Comprehensive Cancer Center, Columbus, OH.ORCID 0000-0001-9714-2782
Jennifer MoughanNRG Oncology Statistics and Data Management Center, Philadelphia, PA.
Julia R WhiteOhio State University Comprehensive Cancer Center, Columbus, OH.ORCID 0000-0001-6624-5631
The University of Texas MD Anderson Cancer Center · USNRG Oncology · USThe Ohio State University · USDartmouth–Hitchcock Medical Center · USHenry Ford Hospital · USHôtel-Dieu de Québec · CAMassachusetts General Hospital · USMemorial Sloan Kettering Cancer Center · USSoutheast Clinical Oncology Research Consortium · USSunnybrook Health Science Centre · CAUniversity of Hawaiʻi at Mānoa · USUniversity of Michigan · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam, GREG YOTHERS · 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
Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Jennifer A. Woyach · 1985 to 2026
$132.3M
NCIC Clinical Trials Group - Canadian Collaborating Clinical Trials NetworkU10CA180863 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI Janet Ellen Dancey · 2014 to 2026
$40.4M
Network Lead Academic Participating Site: Memorial Sloan Kettering Cancer CenterUG1CA233290 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI CAROL AGHAJANIAN, Darren Feldman · 2019 to 2026
$10.2M
OSU as a Network Lead Academic Participating Site for the NCI NCTNUG1CA233331 · NCI · OHIO STATE UNIVERSITY · PI John L. Hays, Dwight H. Owen · 2019 to 2026
$8.9M
UM LAPs -UG1 GrantUG1CA233160 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ANNE F SCHOTT · 2019 to 2026
$5.4M
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA016058NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180863NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA233160NCI NIH HHS UG1 CA233290NCI NIH HHS UG1 CA233331
6 · The paper itself

Abstract

purposeTo our knowledge, NRG/RTOG 9804 is the only randomized trial to assess the impact of whole breast irradiation (radiation therapy [RT]) versus observation (OBS) in women with good-risk ductal carcinoma in situ (DCIS), following lumpectomy. Long-term results focusing on ipsilateral breast recurrence (IBR), the primary outcome, are presented here. PATIENTS AND

methodsEligible patients underwent lumpectomy for DCIS that was mammogram detected, size ≤ 2.5 cm, final margins ≥ 3 mm, and low or intermediate nuclear grade. Consented patients were randomly assigned to RT or OBS. Tamoxifen use was optional. Cumulative incidence was used to estimate IBR, log-rank test and Gray's test to compare treatments, and Fine-Gray regression for hazard ratios (HRs).

resultsA total of six hundred thirty-six women were randomly assigned from 1999 to 2006. Median age was 58 years and mean pathologic DCIS size was 0.60 cm. Intention to use tamoxifen was balanced between arms (69%); however, actual receipt of tamoxifen varied, 58% RT versus 66% OBS (

conclusionRT significantly reduced all and invasive IBR for good-risk DCIS with durable results at 15 years. These results are not an absolute indication for RT but rather should inform shared patient-physician treatment decisions about ipsilateral breast risk reduction in the long term following lumpectomy.

Indexed as

Mastectomy, SegmentalAdultAgedAged, 80 and overBreast NeoplasmsCanadaCarcinoma, Intraductal, NoninfiltratingDose Fractionation, RadiationFemaleHumansMiddle AgedNeoplasm Recurrence, LocalRadiotherapy, AdjuvantRisk AssessmentRisk FactorsTime Factors

Identifiers

PMID34406870
PMCPMC8577682
OpenAlexW3193941051

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.