Evidence map›Paper›PMID 30943123›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Safety and Efficacy of a Five-Fraction Stereotactic Body Radiotherapy Schedule for Centrally Located Non-Small-Cell Lung Cancer: NRG Oncology/RTOG 0813 Trial.

Andrea Bezjak, Rebecca Paulus, Laurie E Gaspar, Robert D Timmerman, William L Straube, William F Ryan, Yolanda I Garces, Anthony T Pu, Anurag K Singh, Gregory M Videtic and 11 more

4 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 271 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
271citing papers in PubMed, 2 pooled it
41.0field-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.

NCT05291780 nacompletednot on this map

STereotactic Ablative RadioTherapy in NEWly Diagnosed and Recurrent Locally Advanced Non-small Cell Lung Canter Patients Unfit for concurrEnt RAdio-chemotherapy

TypeinterventionalSponsorRadiotherapy Oncology Centre "Santa Maria" HospitalRan2015 to 2021Enrolled80ConditionsLocally Advanced Lung Non-Small Cell CarcinomaArmsStereotactic Ablative Radiotherapy in Unresectable Locally Advanced Non-Small Cell Lung Cancer
NCT05615142 phase1active not recruitingnot on this mapstarted 2021, after this paper: background citation

Phase I Study of Low Dose Radiotherapy and Concurrent SBRT in Combination With PD-1 Inhibitors in Advanced Non-small Cell Lung Cancer (NSCLC) .

TypeinterventionalSponsorSichuan UniversityRan2021 to 2026Enrolled9ConditionsNSCLC, Low Dose Radiotherapy, Stereotactic Body Radiotherapy, PD-1 InhibitorArmsLow Dose Radiotherapy, stereotactic body radiation therapy, PD-1 Inhibitors
NCT06542159 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases: a Prospective, Randomized, Controlled Phase II Study

TypeinterventionalSponsorSun Yat-sen UniversityRan2024 to 2028Enrolled130ConditionsAdaptive Radiotherapy, Stereotactic Body Radiotherapy, Non-small Cell Lung Cancer, Lung OligometastasesArmsOnline adaptive SBRT, Conventional SBRT
NCT06730295 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Centrally Located Early-stage Non-small Cell Lung Cancer: a Prospective, Single-arm, Phase II Study

TypeinterventionalSponsorSun Yat-sen UniversityRan2024 to 2028Enrolled52ConditionsLung Cancer (NSCLC)ArmsOnline adaptive SBRT
3 · Its place in the literature

Who cites it

271 citing papers in PubMed, 2 syntheses or guidelines pooled it, 534 citations in OpenAlex.

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211 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 17 institutions in 2 countries.

Andrea Bezjak1 Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
Rebecca Paulus2 NRG Oncology, Philadelphia, PA.
Laurie E Gaspar3 University of Colorado Denver, Aurora, CO.
Robert D Timmerman4 The University of Texas Southwestern, Dallas, TX.
William L Straube5 Washington University in St Louis, St Louis, MO.
William F Ryan6 Pocono Medical Center, East Stroudsburg, PA.
Yolanda I Garces7 Mayo Clinic, Rochester, MN.
Anthony T Pu8 Sutter General Hospital, Sacramento, CA.
Anurag K Singh9 Roswell Park Cancer Institute, Buffalo, NY.
Gregory M Videtic10 Cleveland Clinic Foundation, Cleveland, OH.
Ronald C McGarry11 University of Kentucky, Lexington, KY.
Puneeth Iyengar4 The University of Texas Southwestern, Dallas, TX.
Jason R Pantarotto12 Ottawa Hospital and Cancer Center, Ottawa, Ontario, Canada.
James J Urbanic13 University of California, San Diego, La Jolla, CA.
Alexander Y Sun1 Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
Megan E Daly14 University of California, Davis, Davis, CA.
Inga S Grills15 William Beaumont Hospital, Royal Oak, MI.
Paul Sperduto16 Metro-Minnesota Community Clinical Oncology Program, St Louis Park, MN.
Daniel P Normolle17 University of Pittsburgh Medical Center, Pittsburgh, PA.
Jeffrey D Bradley5 Washington University in St Louis, St Louis, MO.
Hak Choy4 The University of Texas Southwestern, Dallas, TX.
The University of Texas Southwestern Medical Center · USPrincess Margaret Cancer Centre · CAWashington University in St. Louis · USBeaumont Hospital, Royal Oak · USCleveland Clinic · USLehigh Valley Hospital-Pocono · USMayo Clinic in Arizona · USMetro-Minnesota Community Oncology Research Consortium · USNRG Oncology · USOttawa Hospital · CARoswell Park Comprehensive Cancer Center · USSutter Medical Center · USUniversity of California, Davis · USUniversity of California, San Diego · USUniversity of Colorado Denver · USUniversity of Kentucky · USUniversity of Pittsburgh Medical Center · 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
VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Jessie Nedrow · 1988 to 2026
$158.0M
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
UT Southwestern NCI National Clinical Trials Network (NCTN) LAPS - Supplemental Funds YR4UG1CA233302 · NCI · UT SOUTHWESTERN MEDICAL CENTER · PI David Eric Gerber · 2019 to 2026
$6.4M
NCI National Clinical Trials Network - Lead Academic Participating SiteUG1CA233324 · NCI · UNIVERSITY OF COLORADO DENVER · PI ANTHONY D ELIAS · 2019 to 2026
$5.2M
University of Colorado NTCN Lead Academic Participating Site (LAPS) U10CA180834 · NCI · UNIVERSITY OF COLORADO DENVER · PI ELIAS, ANTHONY D · 2014 to 2018
$3.8M
UCDCCC NCTN UG1 PROGRAMUG1CA233340 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI GANDARA, DAVID R, VALICENTI, RICHARD · 2019 to 2025
$3.7M
UCDCCC NCTN U10 ProgramU10CA180846 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI GANDARA, DAVID R, VALICENTI, RICHARD · 2014 to 2018
$3.3M
Network Lead Academic Participating Site Grant from the Roswell Park Cancer InstituteUG1CA233191 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI LELE, SHASHIKANT, LEVINE, ELLIS G · 2019 to 2025
$3.1M
Network Lead Academic Participating Site Grant from the Roswell Cancer Inst.U10CA180866 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI ERNSTOFF, MARC S, LELE, SHASHIKANT · 2014 to 2018
$2.9M
NCI NIH HHS P30 CA047904NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180834NCI NIH HHS U10 CA180846NCI NIH HHS U10 CA180866NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA180803NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA233191NCI NIH HHS UG1 CA233302NCI NIH HHS UG1 CA233324NCI NIH HHS UG1 CA233340
6 · The paper itself

Abstract

purposePatients with centrally located early-stage non-small-cell lung cancer (NSCLC) are at a higher risk of toxicity from high-dose ablative radiotherapy. NRG Oncology/RTOG 0813 was a phase I/II study designed to determine the maximum tolerated dose (MTD), efficacy, and toxicity of stereotactic body radiotherapy (SBRT) for centrally located NSCLC. MATERIALS AND

methodsMedically inoperable patients with biopsy-proven, positron emission tomography-staged T1 to 2 (≤ 5 cm) N0M0 centrally located NSCLC were accrued into a dose-escalating, five-fraction SBRT schedule that ranged from 10 to 12 Gy/fraction (fx) delivered over 1.5 to 2 weeks. Dose-limiting toxicity (DLT) was defined as any treatment-related grade 3 or worse predefined toxicity that occurred within the first year. MTD was defined as the SBRT dose at which the probability of DLT was closest to 20% without exceeding it.

resultsOne hundred twenty patients were accrued between February 2009 and September 2013. Patients were elderly, there were slightly more females, and the majority had a performance status of 0 to 1. Most cancers were T1 (65%) and squamous cell (45%). Organs closest to planning target volume/most at risk were the main bronchus and large vessels. Median follow-up was 37.9 months. Five patients experienced DLTs; MTD was 12.0 Gy/fx, which had a probability of a DLT of 7.2% (95% CI, 2.8% to 14.5%). Two-year rates for the 71 evaluable patients in the 11.5 and 12.0 Gy/fx cohorts were local control, 89.4% (90% CI, 81.6% to 97.4%) and 87.9% (90% CI, 78.8% to 97.0%); overall survival, 67.9% (95% CI, 50.4% to 80.3%) and 72.7% (95% CI, 54.1% to 84.8%); and progression-free survival, 52.2% (95% CI, 35.3% to 66.6%) and 54.5% (95% CI, 36.3% to 69.6%), respectively.

conclusionThe MTD for this study was 12.0 Gy/fx; it was associated with 7.2% DLTs and high rates of tumor control. Outcomes in this medically inoperable group of mostly elderly patients with comorbidities were comparable with that of patients with peripheral early-stage tumors.

Indexed as

AgedAged, 80 and overCarcinoma, Non-Small-Cell LungDose Fractionation, RadiationDose-Response Relationship, RadiationFemaleHumansLung NeoplasmsMaleMiddle AgedRadiosurgeryTreatment Outcome

Identifiers

PMID30943123
PMCPMC6524984
OpenAlexW2926245852

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.