Evidence map›Paper›PMID 29913254›Full record

Trial reportInternational journal of radiation oncology, biology, physics2018

Patient Reported Outcomes in NRG Oncology RTOG 0938, Evaluating Two Ultrahypofractionated Regimens for Prostate Cancer.

Himanshu R Lukka, Stephanie L Pugh, Deborah W Bruner, Jean-Paul Bahary, Colleen A F Lawton, Jason A Efstathiou, Rajat J Kudchadker, Lee E Ponsky, Samantha A Seaward, Ian S Dayes and 11 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04831983 (Single-Dose Image-Guided Radiotherapy), which is not on this map. Cited by 37 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 2 pooled it
–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.

NCT04831983 recruitingnot on this mapstarted 2021, after this paper: background citation

Single-Dose Image-Guided Radiotherapy (IGRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume for Intermediate Unfavorable and High Risk Prostate Cancer

TypeobservationalSponsorUniversity of Milano BicoccaRan2021 to 2029Enrolled30ConditionsProstate Cancer
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Diminishing Returns From Ultrahypofractionated Radiation Therapy for Prostate Cancer.International journal of radiation oncology, biology, physics · 2020
    Pooled it
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  4. Randomized Trial of Conventional Versus Conventional Plus Fluciclovine (International journal of radiation oncology, biology, physics · 2022
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  16. Dosimetric evaluation of ultrafractionated dose escalation with simultaneous integrated boost to intraprostatic lesion using 1.5-Tesla MR-Linac in localized prostate cancer.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2024
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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

21 authors.

Himanshu R LukkaJuravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: lukkahim@hhsc.ca.
Stephanie L PughNRGOncologyStatistics and Data Management Center, Philadelphia, Pennsylvania.
Deborah W BrunerEmory University, Winship Cancer Institute, Atlanta, Georgia.
Jean-Paul BaharyCentre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.
Colleen A F LawtonFroedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin.
Jason A EfstathiouMassachusetts General Hospital, Boston, Massachusetts.
Rajat J KudchadkerMD Anderson Cancer Center, Houston, Texas.
Lee E PonskyCase Western Reserve University, Cleveland, Ohio.
Samantha A SeawardKaiser Permanente Northern California, Santa Clara, California.
Ian S DayesJuravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada.
Darindra D GopaulGrand River Hospital, Kitchener, Ontario, Canada.
Jeff M MichalskiWashington University, St Louis, Missouri.
Guila DelouyaCentre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.
Irving D KaplanDana-Farber Cancer Institute, Boston, Massachusetts.
Eric M HorwitzFox Chase Cancer Center, Philadelphia, Pennsylvania.
Mack RoachUniversity of California-San Francisco Medical Center, San Francisco, California.
Wayne H PinoverAbington Memorial Hospital, Abington, Pennsylvania.
David C BeyerArizona Oncology Services Foundation, Tucson, Arizona.
John O AmanieCross Cancer Institute, Edmonton, Alberta, Canada.
Howard M SandlerCedars-Sinai Medical Center, Los Angeles, California.
Lisa A KachnicVanderbilt University Medical Center, Nashville, Tennessee.

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 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
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
Washington University/ Siteman Cancer Center Lead Academic SiteU10CA180833 · NCI · WASHINGTON UNIVERSITY · PI BARTLETT, NANCY L, KOZOWER, BENJAMIN D · 2014 to 2018
$7.6M
NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180833NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA180803NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

purposeThere is considerable interest in very short (ultrahypofractionated) radiation therapy regimens to treat prostate cancer based on potential radiobiological advantages, patient convenience, and resource allocation benefits. Our objective is to demonstrate that detectable changes in health-related quality of life measured by the bowel and urinary domains of the Expanded Prostate Cancer Index Composite (EPIC-50) were not substantially worse than baseline scores. METHODS AND MATERIALS: NRG Oncology's RTOG 0938 is a nonblinded randomized phase 2 study of National Comprehensive Cancer Network low-risk prostate cancer in which each arm is compared with a historical control. Patients were randomized to 5 fractions (7.25 Gy in 2 weeks) or 12 fractions (4.3 Gy in 2.5 weeks). The co-primary endpoints were the proportion of patients with a change in EPIC-50 bowel score at 1 year (baseline to 1 year) >5 points and in EPIC-50 urinary score >2 points tested with a 1-sample binomial test.

resultsThe study enrolled 127 patients to 5 fractions (121 analyzed) and 128 patients to 12 fractions (125 analyzed). Median follow-up for all patients at the time of analysis was 3.8 years. The 1-year frequency for >5 point change in bowel score were 29.8% (P < .001) and 28.4% (P < .001) for 5 and 12 fractions, respectively. The 1-year frequencies for >2 point change in urinary score were 45.7% (P < .001) and 42.2% (P < .001) for 5 and 12 fractions, respectively. For 5 fractions, 32.9% of patients had a drop in 1-year EPIC-50 sexual score of ≥11 points (P = .34); for 12 fractions, 30.9% of patients had a drop in 1-year EPIC-50 sexual score of ≥ 11 points (P = .20). Disease-free survival at 2 years is 99.2% (95% confidence interval: 97.5-100) in the 5-fraction arm and 97.5% (95% confidence interval: 94.6-100) in the 12-fraction arm. There was no late grade 4 or 5 treatment-related urinary or bowel toxicity.

conclusionsThis study confirms that, based on changes in bowel and urinary domains and toxicity (acute and late), the 5- and 12-fraction regimens are well tolerated. These ultrahypofractionated approaches need to be compared with current standard radiation therapy regimens.

Indexed as

Patient Reported Outcome MeasuresQuality of LifeRadiation Dose HypofractionationAgedDisease-Free SurvivalFemur HeadFollow-Up StudiesHumansMaleMiddle AgedOrgans at RiskPenisProstatic NeoplasmsRadiotherapyRectumUrethra

Identifiers

PMID29913254
PMCPMC6248906

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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.