Evidence map›Paper›PMID 36592721›Full record

Trial reportInternational journal of radiation oncology, biology, physics2023

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

Himanshu R Lukka, Snehal Deshmukh, 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 10 more

Open access · greenAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.4field-weighted citation impact, top 18% 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

6 citing papers in PubMed, 11 citations in OpenAlex.

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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

20 authors at 16 institutions in 2 countries.

Himanshu R LukkaJuravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Canada. Electronic address: lukkahim@hhsc.ca.
Snehal DeshmukhNRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
Deborah W BrunerEmory University, Winship Cancer Institute, Atlanta, Georgia.
Jean-Paul BaharyCentre Hospitalier de l'Universite´ de Montreal (CHUM), Montreal, Canada.
Colleen A F LawtonMedical 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, Oakland, California.
Ian S DayesJuravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Canada.
Darindra D GopaulGrand River Hospital, Kitchener, Canada.
Jeff M MichalskiWashington University, St Louis, Missouri.
Guila DelouyaCentre Hospitalier de l'Universite´ de Montreal (CHUM), Montreal, Canada.
Irving D KaplanBeth Israel Deaconess Medical Center, Boston, Massachusetts.
Eric M HorwitzFox Chase Cancer Center, Philadelphia, Pennsylvania.
Mack RoachUniversity of California-San Francisco Medical Center, San Francisco, California.
Felix Y FengUniversity of California-San Francisco Medical Center, San Francisco, California.
Stephanie L PughNRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
Howard M SandlerCedars-Sinai Medical Center, Los Angeles, California.
Lisa A KachnicJuravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Canada.
Centre Hospitalier de l’Université de Montréal · CAHamilton Health Sciences · CANRG Oncology · USUniversity of California San Francisco Medical Center · USBeth Israel Deaconess Medical Center · USCase Western Reserve University · USCedars-Sinai Medical Center · USEmory University · USFox Chase Cancer Center · USGrand River Hospital · CAJuravinski Cancer Centre · CAKaiser Permanente · USMassachusetts General Hospital · USMedical College of Wisconsin · USThe University of Texas MD Anderson Cancer Center · USWashington University in St. Louis · 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
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
WASHINGTON UNIVERSITY / SITEMAN CANCER CENTER LEAD ACADEMIC SITEUG1CA233339 · NCI · WASHINGTON UNIVERSITY · PI NANCY L BARTLETT, Clifford Grant Robinson · 2019 to 2026
$11.3M
NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA180803NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA233339
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 week and a day [twice a week]) or 12 fractions (4.3Gy in 2.5 weeks [5 times a week]). Secondary objectives assessed patient-reported toxicity at 5 years using the EPIC. Chi-square tests were used to assess the proportion of patients with a deterioration from baseline of >5 points for bowel, >2 points for urinary, and >11 points for sexual score.

resultsThe study enrolled 127 patients to 5 fractions (121 eligible) and 128 patients to 12 fractions (125 eligible). The median follow-up for all patients at the time of analysis was 5.38 years. The 5-year frequency for >5 point change in bowel score were 38.4% (P = .27) and 23.4% (P = 0.98) for 5 and 12 fractions, respectively. The 5-year frequencies for >2 point change in urinary score were 46.6% (P = .15) and 36.4% (P = .70) for 5 and 12 fractions, respectively. For 5 fractions, 49.3% (P = .007) of patients had a drop in 5-year EPIC-50 sexual score of ≥11 points; for 12 fractions, 54% (P < .001) of patients had a drop in 5-year EPIC-50 sexual score of ≥11 points. Disease-free survival at 5 years is 89.6% (95% CI: 84.0-95.2) in the 5-fraction arm and 92.3% (95% CI: 87.4-97.1) 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 long-term changes in bowel and urinary domains and toxicity, the 5- and 12-fraction regimens are well tolerated. These ultrahypofractionated approaches need to be compared with current standard radiation therapy regimens.

Indexed as

Prostatic NeoplasmsQuality of LifeDisease-Free SurvivalHumansIntestinesMalePatient Reported Outcome Measures

Identifiers

PMID36592721
PMCPMC10619484
OpenAlexW4313398863

What OpenQuestion holds

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Registered trials

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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.