The purpose of this study is to develop radiation plans that will help preserve lung function in healthy tissue surrounding the tumor. We believe that 4DCT scans can be useful in designing radiation treatment plans that help us avoid healthy normal functioning lung tissue close to lung tumors. Currently 4DCT scans are used to help us determine exactly where the tumor is and how it moves when you breathe. In this study we will also use the 4DCT scans to try to identify high functioning normal lung tissue.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
Correlative studies
60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
UW Johnson Creek
Johnson Creek, Wisconsin, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Pulmonary Function, Based on Changes in Tissue Elasticity Measured From 4DCT
The primary endpoint of this study will be the ratio of the tissue elasticity map following RT to the elasticity map before RT (i.e., the Jacobian ratio of (post RT /pre RT)) calculated from 4DCT at 3 months post-RT. Based on the randomness of our measurement technique, diminished expansion (i.e. substantial change) is defined as a Jacobian ratio \<0.94 (i.e., less than 94% of the pre-RT value).
Time frame: 3 months post RT
Temporal Changes in Reduced Elasticity Determined by the Volume of Lung Where Expansion is Improved (Percent Change)
Changes in Reduced Elasticity (defined as \< 0.94\*median) Determined by the Volume of Lung Where Expansion is Improved (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.
Time frame: During therapy to 12 months post-RT
Temporal Changes in Reduced Elasticity Determined by the Volume of Lung Where Expansion is Improved (Ratio)
Changes in Reduced Elasticity (defined as \< 0.94\*median) Determined by the Volume of Lung Where Expansion is Improved (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.
Time frame: During therapy to 12 months post-RT
Temporal Changes in Increased Elasticity Determined by the Volume of Lung Where Expansion is Improved (Percent Change)
Changes in Increased Elasticity (defined as \> 1.06\*median) Determined by the Volume of Lung Where Expansion is Improved (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.
Time frame: During therapy to 12 months post-RT
Temporal Changes in Increased Elasticity Determined by the Volume of Lung Where Expansion is Improved (Ratio)
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Subjects undergo a total of 7 research-ordered four dimensional computed tomographic imaging (4DCT) scans: 1 at simulation, and 2 scans at each of the 3 post-radiation therapy time points (3, 6, and 12 months). 4DCT determines lung tissue elasticity and for standard of care radiation treatment planning.
Changes in Increased Elasticity (defined as \> 1.06\*median) Determined by the Volume of Lung Where Expansion is Improved (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.
Time frame: During therapy to 12 months post-RT
Temporal Changes in Fraction of Expanding Lung Determined by the Volume of Lung Where "Meaningful" Expansion Occurs (Percent Change)
Changes in Expansion of Lung Determined by the Volume of Lung Where "Meaningful" Expansion (defined as \> 1.1\*median ) Occurs (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.
Time frame: During therapy to 12 months post-RT
Temporal Changes in Fraction of Expanding Lung Determined by the Volume of Lung Where "Meaningful" Expansion Occurs (Ratio)
Changes in Expansion of Lung Determined by the Volume of Lung Where "Meaningful" Expansion (defined as \> 1.1\*median ) Occurs (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.
Time frame: During therapy to 12 months post-RT
Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs)
Median absolute change in the percent predicted following pulmonary function tests reported: Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), and diffusing capacity of carbon monoxide (DLCO). All statistical tests will be two-sided and assessed for significance at the 5% level.
Time frame: Pre-RT up to 12 months post-RT
Validation in Consistency of Tissue Elasticity Changes Measured With Values Predicted Based on Existing Radiation Dose Response Curves
All statistical tests will be two-sided and assessed for significance at the 5% level.
Time frame: Up to 12 months post-RT
Variation of the Tissue Elasticity Calculated Between Scan 1 and Scan 2 at Each Time Point Will be Quantified and Compared to Longitudinal Changes in Tissue Elasticity
All statistical tests will be two-sided and assessed for significance at the 5% level.
Time frame: Up to 12 months post-RT