Evidence map›Paper›PMID 34767934›Full record

Trial reportInternational journal of radiation oncology, biology, physics2022

Results of a Multi-Institutional Phase 2 Clinical Trial for 4DCT-Ventilation Functional Avoidance Thoracic Radiation Therapy.

Yevgeniy Vinogradskiy, Richard Castillo, Edward Castillo, Leah Schubert, Bernard L Jones, Austin Faught, Laurie E Gaspar, Jennifer Kwak, Daniel W Bowles, Timothy Waxweiler and 8 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 2 pooled it
9.3field-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.

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

42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 60 citations in OpenAlex.

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  6. Evaluation of variables predicting PFT changes for lung cancer patients treated on a prospective 4DCT-ventilation functional avoidance clinical trial.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2023
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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

18 authors at 6 institutions in 1 country.

Yevgeniy VinogradskiyDepartment of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado; Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania. Electronic address: yevgeniy.vinogradskiy@jefferson.edu.
Richard CastilloDepartment of Radiation Oncology, Emory University, Atlanta, Georgia.
Edward CastilloDepartment of Radiation Oncology, Beaumont Health System, Royal Oak, Michigan.
Leah SchubertDepartment of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado.
Bernard L JonesDepartment of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado.
Austin FaughtDepartment of Radiation Oncology, St Jude Children's Research Hospital, Memphis, Tennessee.
Laurie E GasparDepartment of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado.
Jennifer KwakDepartment of Radiology, University of Colorado School of Medicine, Aurora, Colorado.
Daniel W BowlesDivision of Medical Oncology, University of Colorado School of Medicine, Aurora, Colorado; Rocky Mountain Regional VA Medical Center, Aurora, Colorado.
Timothy WaxweilerDepartment of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado.
Jingjing M DoughertyDepartment of Radiation Oncology, Mayo Clinic, Jacksonville, Florida.
Dexiang GaoDepartments of Pediatrics and Biostatistics and Informatics, University of Colorado School of Medicine, Aurora, Colorado.
Craig StevensDepartment of Radiation Oncology, Beaumont Health System, Royal Oak, Michigan.
Moyed MiftenDepartment of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado.
Brian KavanaghDepartment of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado.
Inga GrillsDepartment of Radiation Oncology, Beaumont Health System, Royal Oak, Michigan.
Chad G RusthovenDepartment of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado.
Thomas GuerreroDepartment of Radiation Oncology, Beaumont Health System, Royal Oak, Michigan.
University of Colorado Denver · USBeaumont Health · USEmory University · USSt. Jude Children's Research Hospital · USThomas Jefferson University · USWinnMed · US

Funding

University of Colorado Cancer Center Support Grant - Lung Cancer Patient-Derived Xenografts with Autologous Human Immune SystemsP30CA046934 · NCI · UNIVERSITY OF COLORADO DENVER · PI James V Degregori · 1988 to 2026
$117.0M
Nutrition, Biostatistics and BioinformaticsR25CA090301 · NCI · TEXAS A&M UNIVERSITY SYSTEM · PI CARROLL, RAYMOND J. · 2001 to 2015
$7.6M
Spatially Accurate Deformable Image Registration for Thoracic CT ApplicationDP2OD007044 · OD · WILLIAM BEAUMONT HOSPITAL RESEARCH INST · PI GUERRERO, THOMAS M · 2010 to 2013
$2.6M
Development of a Novel Lung Function Imaging Modality for comprehensive management of lung cancerR01CA236857 · NCI · UNIVERSITY OF COLORADO DENVER · PI CASTILLO, EDWARD, CASTILLO, RICHARD · 2020 to 2025
$2.4M
Nutrition, Biostatistics & Bioinformatics Training GrantT32CA090301 · NCI · TEXAS A&M UNIVERSITY · PI CARROLL, RAYMOND J. · 2016 to 2020
$712k
Quantitative Lung Function Imaging to Reduce Toxicity for patients treated with Radiation and ImmunotherapyUG3CA247605 · NCI · THOMAS JEFFERSON UNIVERSITY · PI CASTILLO, EDWARD, CASTILLO, RICHARD · 2021 to 2022
$664k
Medical Physics Training Grant for Image-Guided Therapy ResearchT32CA119930 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI JACKSON, EDWARD F · 2006 to 2010
$636k
Clinical trial personalizing radiation therapy through a novel lung function imaging modalityR01CA200817 · NCI · UNIVERSITY OF COLORADO DENVER · PI VINOGRADSKIY, YEVGENIY · 2016 to 2018
$618k
A Bayesian Framework for Inter-Modality Deformable Image Registration EvaluationK01CA181292 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI CASTILLO, RICHARD · 2013 to 2016
$478k
Phase II validation of 4-dimensional computed tomography derived ventilation forR21CA128230 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI GUERRERO, THOMAS M · 2007 to 2008
$286k
NCI NIH HHS K01 CA181292NCI NIH HHS P30 CA046934NCI NIH HHS R01 CA200817NCI NIH HHS R01 CA236857NCI NIH HHS R21 CA128230NCI NIH HHS R25 CA090301NCI NIH HHS T32 CA090301NCI NIH HHS T32 CA119930NCI NIH HHS UG3 CA247605NIH HHS DP2 OD007044
6 · The paper itself

Abstract

purposeRadiation pneumonitis remains a major limitation in the radiation therapy treatment of patients with lung cancer. Functional avoidance radiation therapy uses functional imaging to reduce pulmonary toxic effects by designing radiation therapy plans that reduce doses to functional regions of the lung. Lung functional imaging has been developed that uses 4-dimensional computed tomography (4DCT) imaging to calculate 4DCT-based lung ventilation (4DCT-ventilation). A phase 2 multicenter study was initiated to evaluate 4DCT-ventilation functional avoidance radiation therapy. The study hypothesis was that functional avoidance radiation therapy could reduce the rate of grade ≥2 radiation pneumonitis to 12% compared with a 25% historical rate, with the trial being positive if ≤16.4% of patients experienced grade ≥2 pneumonitis. METHODS AND MATERIALS: Lung cancer patients receiving curative-intent radiation therapy (prescription doses of 45-75 Gy) and chemotherapy were accrued. Patient 4DCT scans were used to generate 4DCT-ventilation images. The 4DCT-ventilation images were used to generate functional avoidance plans that reduced doses to functional portions of the lung while delivering the prescribed tumor dose. Pneumonitis was evaluated by a clinician at 3, 6, and 12 months after radiation therapy.

resultsSixty-seven evaluable patients were accrued between April 2015 and December 2019. The median prescription dose was 60 Gy (range, 45-66 Gy) delivered in 30 fractions (range, 15-33 fractions). The average reduction in the functional volume of lung receiving ≥20 Gy with functional avoidance was 3.5% (range, 0%-12.8%). The median follow-up was 312 days. The rate of grade ≥2 radiation pneumonitis was 10 of 67 patients (14.9%; 95% upper CI, 24.0%), meeting the phase 2 criteria.

conclusions4DCT-ventilation offers an imaging modality that is convenient and provides functional imaging without an extra procedure necessary. This first report of a multicenter study of 4DCT-ventilation functional avoidance radiation therapy provided data showing that the trial met phase 2 criteria and that evaluation in a phase 3 study is warranted.

Indexed as

Lung NeoplasmsRadiation PneumonitisFour-Dimensional Computed TomographyHumansLungPulmonary VentilationRadiotherapy Planning, Computer-Assisted

Identifiers

PMID34767934
PMCPMC8863640
OpenAlexW3209930766

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.