Evidence map›Paper›PMID 30353873›Full record

Trial reportInternational journal of radiation oncology, biology, physics2018

Interim Analysis of a Two-Institution, Prospective Clinical Trial of 4DCT-Ventilation-based Functional Avoidance Radiation Therapy.

Yevgeniy Vinogradskiy, Chad G Rusthoven, Leah Schubert, Bernard Jones, Austin Faught, Richard Castillo, Edward Castillo, Laurie E Gaspar, Jennifer Kwak, Timothy Waxweiler and 7 more

Abstract readClinical TrialMulticenter Study
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. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
3.6field-weighted citation impact, top 6% 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

26 citing papers in PubMed, 40 citations in OpenAlex.

  1. 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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  13. HyperpolarizedInternational journal of radiation oncology, biology, physics · 2021
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  16. Characterizing spatial differences between SPECT-ventilation and SPECT-perfusion in patients with lung cancer undergoing radiotherapy.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2021
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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

17 authors at 5 institutions in 1 country.

Yevgeniy VinogradskiyDepartment of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado. Electronic address: yevgeniy.vinogradskiy@ucdenver.edu.
Chad G RusthovenDepartment of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado.
Leah SchubertDepartment of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado.
Bernard 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.
Richard CastilloDepartment of Radiation Oncology, Emory University, Atlanta, Georgia.
Edward CastilloDepartment of Radiation Oncology, Beaumont Health System, Royal Oak, Michigan.
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.
Timothy WaxweilerDepartment of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado.
Michele DoughertyDepartment of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.
Dexiang GaoDepartment of Pediatrics and Department of 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.
Thomas GuerreroDepartment of Radiation Oncology, Beaumont Health System, Royal Oak, Michigan.
Inga GrillsDepartment of Radiation Oncology, Beaumont Health System, Royal Oak, Michigan.
University of Colorado Denver · USBeaumont Health · USEmory University · USMayo Clinic · USSt. Jude Children's Research Hospital · 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
Clinical trial personalizing radiation therapy through a novel lung function imaging modalityR01CA200817 · NCI · UNIVERSITY OF COLORADO DENVER · PI VINOGRADSKIY, YEVGENIY · 2016 to 2018
$618k
NCI NIH HHS P30 CA046934NCI NIH HHS R01 CA200817
6 · The paper itself

Abstract

purposeFunctional imaging has been proposed that uses 4DCT images to calculate 4DCT-based lung ventilation (4DCT-ventilation). We have started a 2-institution, phase 2 prospective trial evaluating the feasibility, safety, and preliminary efficacy of 4DCT-ventilation functional avoidance. The trial hypothesis is that the rate of grade ≥2 radiation pneumonitis could be reduced to 12% with functional avoidance, compared with a 25% rate of pneumonitis with a historical control. The trial employed a Simon 2-stage design with a planned futility analysis after 17 evaluable patients. The purpose of this work is to present the trial design and implementation, dosimetric data, and clinical results for the planned futility analysis. METHODS AND MATERIALS: Eligible patients were patients with lung cancer who were prescribed doses of 45 to 75 Gy. For each patient, the 4DCT data were used to generate a 4DCT-ventilation image using the Hounsfield unit technique along with a compressible flow-based image registration algorithm. Two intensity modulated radiation therapy treatment plans were generated: (1) a standard lung plan and (2) a functional avoidance treatment plan that aimed to reduce dose to functional lung while meeting target and normal tissue constraints. Patients were treated with the functional avoidance plan and evaluated for thoracic toxicity (presented as rate and 95% confidence intervals [CI]) with a 1-year follow-up.

resultsThe V20 to functional lung was 21.6% ± 9.5% (mean ± standard deviation) with functional avoidance, representing a decrease of 3.2% (P < .01) relative to standard, nonfunctional treatment plans. The rates of grade ≥2 and grade ≥3 radiation pneumonitis were 17.6% (95% CI, 3.8%-43.4%) and 5.9% (95% CI, 0.1%-28.7%), respectively.

conclusionsDosimetrically, functional avoidance achieved reduction in doses to functional lung while meeting target and organ at risk constraints. On the basis of Simon's 2-stage design and the 17.6% grade ≥2 pneumonitis rate, the trial met its futility criteria and has continued accrual.

Indexed as

Radiotherapy Planning, Computer-AssistedFemaleFour-Dimensional Computed TomographyHumansLung NeoplasmsMaleProspective StudiesPulmonary VentilationRadiation PneumonitisRadiotherapy DosageRadiotherapy, Intensity-ModulatedResearch Design

Identifiers

PMID30353873
PMCPMC6919556
OpenAlexW2896543351

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.