Trial Outcomes & Findings for Improving Pulmonary Function Following Radiation Therapy (NCT NCT02843568)
NCT ID: NCT02843568
Last Updated: 2024-10-10
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
3 months post RT
Results posted on
2024-10-10
Participant Flow
Participant milestones
| Measure |
Standard of Care
Subjects undergo 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. Subjects undergo laboratory biomarker analysis, including spirometry, diffusion capacity (DLCO), and lung volumes (FEV, FEV1). Subjects complete a self-assessment, RTOG defined acute evaluation toxicity evaluation, RTOG late toxicity evaluation, and constitutional assessment.
Radiation doses between 60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation schemes are utilized. Treatment volumes are at the discretion of the treating radiation oncologist and should follow standard of care.
Laboratory Biomarker Analysis: Correlative studies
Standard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
Stereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
Four Dimensional Computed Tomographic Imaging (4DCT): 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.
|
Pulmonary Function Damage Reduction
All criteria and specifications in the standard of care arm are applicable for this arm, including the same 4DCT scans, and laboratory biomarker analysis. Subjects randomized to this arm of the trial will have the same prescribed radiation dose to the tumor volume and held to the same radiation dose criteria as the subjects in the standard of care arm (60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation). The fundamental difference will be radiation doses for these subjects will be redistributed away from regions predicted to cause the greatest reduction in pulmonary function if damaged.
Laboratory Biomarker Analysis: Correlative studies
Standard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
Stereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
Four Dimensional Computed Tomographic Imaging (4DCT): 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.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
57
|
|
Overall Study
Evaluable for Primary Analysis
|
61
|
55
|
|
Overall Study
SBRT Cohort (Analyzed for Toxicities)
|
30
|
31
|
|
Overall Study
Conventional Cohort (Analyzed for Toxicities)
|
31
|
24
|
|
Overall Study
Participants at 3 Months
|
57
|
51
|
|
Overall Study
Participants at 6 Months
|
53
|
43
|
|
Overall Study
Participants at 12 Months
|
43
|
34
|
|
Overall Study
Analyzed for Primary Endpoints
|
55
|
51
|
|
Overall Study
COMPLETED
|
55
|
51
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
Reasons for withdrawal
| Measure |
Standard of Care
Subjects undergo 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. Subjects undergo laboratory biomarker analysis, including spirometry, diffusion capacity (DLCO), and lung volumes (FEV, FEV1). Subjects complete a self-assessment, RTOG defined acute evaluation toxicity evaluation, RTOG late toxicity evaluation, and constitutional assessment.
Radiation doses between 60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation schemes are utilized. Treatment volumes are at the discretion of the treating radiation oncologist and should follow standard of care.
Laboratory Biomarker Analysis: Correlative studies
Standard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
Stereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
Four Dimensional Computed Tomographic Imaging (4DCT): 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.
|
Pulmonary Function Damage Reduction
All criteria and specifications in the standard of care arm are applicable for this arm, including the same 4DCT scans, and laboratory biomarker analysis. Subjects randomized to this arm of the trial will have the same prescribed radiation dose to the tumor volume and held to the same radiation dose criteria as the subjects in the standard of care arm (60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation). The fundamental difference will be radiation doses for these subjects will be redistributed away from regions predicted to cause the greatest reduction in pulmonary function if damaged.
Laboratory Biomarker Analysis: Correlative studies
Standard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
Stereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
Four Dimensional Computed Tomographic Imaging (4DCT): 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.
|
|---|---|---|
|
Overall Study
Excluded from Primary Population due to change in treatment
|
4
|
2
|
|
Overall Study
Death
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Improving Pulmonary Function Following Radiation Therapy
Baseline characteristics by cohort
| Measure |
Standard of Care
n=61 Participants
Subjects undergo 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. Subjects undergo laboratory biomarker analysis, including spirometry, diffusion capacity (DLCO), and lung volumes (FEV, FEV1). Subjects complete a self-assessment, RTOG defined acute evaluation toxicity evaluation, RTOG late toxicity evaluation, and constitutional assessment.
Radiation doses between 60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation schemes are utilized. Treatment volumes are at the discretion of the treating radiation oncologist and should follow standard of care.
Laboratory Biomarker Analysis: Correlative studies
Standard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
Stereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
Four Dimensional Computed Tomographic Imaging (4DCT): 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.
|
Pulmonary Function Damage Reduction
n=55 Participants
All criteria and specifications in the standard of care arm are applicable for this arm, including the same 4DCT scans, and laboratory biomarker analysis. Subjects randomized to this arm of the trial will have the same prescribed radiation dose to the tumor volume and held to the same radiation dose criteria as the subjects in the standard of care arm (60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation). The fundamental difference will be radiation doses for these subjects will be redistributed away from regions predicted to cause the greatest reduction in pulmonary function if damaged.
Laboratory Biomarker Analysis: Correlative studies
Standard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
Stereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
Four Dimensional Computed Tomographic Imaging (4DCT): 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.
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
55 participants
n=7 Participants
|
116 participants
n=5 Participants
|
|
Age, Customized
median age
|
69 years
n=5 Participants
|
71 years
n=7 Participants
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months post RTThe 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).
Outcome measures
| Measure |
Standard of Care
n=55 Participants
Subjects undergo 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. Subjects undergo laboratory biomarker analysis, including spirometry, diffusion capacity (DLCO), and lung volumes (FEV, FEV1). Subjects complete a self-assessment, RTOG defined acute evaluation toxicity evaluation, RTOG late toxicity evaluation, and constitutional assessment.
Radiation doses between 60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation schemes are utilized. Treatment volumes are at the discretion of the treating radiation oncologist and should follow standard of care.
Laboratory Biomarker Analysis: Correlative studies
Standard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
Stereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
Four Dimensional Computed Tomographic Imaging (4DCT): 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.
|
Pulmonary Function Damage Reduction
n=51 Participants
All criteria and specifications in the standard of care arm are applicable for this arm, including the same 4DCT scans, and laboratory biomarker analysis. Subjects randomized to this arm of the trial will have the same prescribed radiation dose to the tumor volume and held to the same radiation dose criteria as the subjects in the standard of care arm (60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation). The fundamental difference will be radiation doses for these subjects will be redistributed away from regions predicted to cause the greatest reduction in pulmonary function if damaged.
Laboratory Biomarker Analysis: Correlative studies
Standard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
Stereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
Four Dimensional Computed Tomographic Imaging (4DCT): 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.
|
Standard of Care: SBRT Cohort
Participants undergoing stereotactic body radiation therapy (SBRT) 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
|
Pulmonary Function Damage Reduction: SBRT Cohort
Participants undergoing Stereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
|
|---|---|---|---|---|
|
Pulmonary Function, Based on Changes in Tissue Elasticity Measured From 4DCT
|
1.09 ratio
Interval 0.42 to 2.8
|
1.13 ratio
Interval 0.37 to 3.2
|
—
|
—
|
SECONDARY outcome
Timeframe: During therapy to 12 months post-RTAll statistical tests will be two-sided and assessed for significance at the 5% level.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During therapy to 12 months post-RTAll statistical tests will be two-sided and assessed for significance at the 5% level.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During therapy to 12 months post-RTAll statistical tests will be two-sided and assessed for significance at the 5% level.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 months post-RTAll statistical tests will be two-sided and assessed for significance at the 5% level.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-RT up to 12 months post-RTPopulation: This measures a change from baseline, not all participants completed all time points
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.
Outcome measures
| Measure |
Standard of Care
n=31 Participants
Subjects undergo 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. Subjects undergo laboratory biomarker analysis, including spirometry, diffusion capacity (DLCO), and lung volumes (FEV, FEV1). Subjects complete a self-assessment, RTOG defined acute evaluation toxicity evaluation, RTOG late toxicity evaluation, and constitutional assessment.
Radiation doses between 60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation schemes are utilized. Treatment volumes are at the discretion of the treating radiation oncologist and should follow standard of care.
Laboratory Biomarker Analysis: Correlative studies
Standard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
Stereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
Four Dimensional Computed Tomographic Imaging (4DCT): 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.
|
Pulmonary Function Damage Reduction
n=23 Participants
All criteria and specifications in the standard of care arm are applicable for this arm, including the same 4DCT scans, and laboratory biomarker analysis. Subjects randomized to this arm of the trial will have the same prescribed radiation dose to the tumor volume and held to the same radiation dose criteria as the subjects in the standard of care arm (60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation). The fundamental difference will be radiation doses for these subjects will be redistributed away from regions predicted to cause the greatest reduction in pulmonary function if damaged.
Laboratory Biomarker Analysis: Correlative studies
Standard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
Stereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
Four Dimensional Computed Tomographic Imaging (4DCT): 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.
|
Standard of Care: SBRT Cohort
n=30 Participants
Participants undergoing stereotactic body radiation therapy (SBRT) 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
|
Pulmonary Function Damage Reduction: SBRT Cohort
n=30 Participants
Participants undergoing Stereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
|
|---|---|---|---|---|
|
Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs)
Median Absolute Change in the FEV1 percent predicted from baseline to 3 months
|
-5 percent predicted
Interval -28.0 to 10.0
|
-3 percent predicted
Interval -12.0 to 46.0
|
-2 percent predicted
Interval -15.0 to 10.0
|
-2 percent predicted
Interval -21.0 to 18.0
|
|
Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs)
Median Absolute Change in the FEV1 percent predicted from baseline to 6 months
|
-4 percent predicted
Interval -32.0 to 14.0
|
-4 percent predicted
Interval -15.0 to 13.0
|
-2 percent predicted
Interval -31.0 to 13.0
|
-3 percent predicted
Interval -24.0 to 19.0
|
|
Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs)
Median Absolute Change in the FEV1 percent predicted from baseline to 12 months
|
2 percent predicted
Interval -26.0 to 23.0
|
12 percent predicted
Interval -36.0 to 25.0
|
-2 percent predicted
Interval -18.0 to 12.0
|
-1 percent predicted
Interval -29.0 to 18.0
|
|
Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs)
Median Absolute Change in the FVC percent predicted from baseline to 3 months
|
-6 percent predicted
Interval -34.0 to 11.0
|
1.5 percent predicted
Interval -15.0 to 28.0
|
0 percent predicted
Interval -15.0 to 30.0
|
0 percent predicted
Interval -20.0 to 24.0
|
|
Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs)
Median Absolute Change in the FVC percent predicted from baseline to 6 months
|
-4.5 percent predicted
Interval -35.0 to 20.0
|
-2 percent predicted
Interval -21.0 to 27.0
|
-0.5 percent predicted
Interval -41.0 to 30.0
|
-2 percent predicted
Interval -18.0 to 20.0
|
|
Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs)
Median Absolute Change in the FVC percent predicted from baseline to 12 months
|
-5 percent predicted
Interval -20.0 to 29.0
|
8 percent predicted
Interval -36.0 to 21.0
|
0 percent predicted
Interval -19.0 to 15.0
|
2 percent predicted
Interval -26.0 to 27.0
|
|
Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs)
Median Absolute Change in the DLCO percent predicted from baseline to 3 months
|
-12 percent predicted
Interval -57.0 to 12.0
|
-11 percent predicted
Interval -29.0 to 4.0
|
-2.5 percent predicted
Interval -21.0 to 33.0
|
-2 percent predicted
Interval -52.0 to 22.0
|
|
Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs)
Median Absolute Change in the DLCO percent predicted from baseline to 6 months
|
-11 percent predicted
Interval -62.0 to 15.0
|
-9.5 percent predicted
Interval -33.0 to 7.0
|
-6.5 percent predicted
Interval -31.0 to 15.0
|
-0.5 percent predicted
Interval -43.0 to 24.0
|
|
Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs)
Median Absolute Change in the DLCO percent predicted from baseline to 12 months
|
12 percent predicted
Interval -24.0 to 48.0
|
5 percent predicted
Interval -9.0 to 43.0
|
2.5 percent predicted
Interval -37.0 to 48.0
|
1 percent predicted
Interval -36.0 to 55.0
|
SECONDARY outcome
Timeframe: Baseline up to 12 months post-RTAll statistical tests will be two-sided and assessed for significance at the 5% level.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 12 months post-RTAll statistical tests will be two-sided and assessed for significance at the 5% level.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 months post-RTAll statistical tests will be two-sided and assessed for significance at the 5% level.
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care
Serious events: 7 serious events
Other events: 61 other events
Deaths: 3 deaths
Pulmonary Function Damage Reduction
Serious events: 10 serious events
Other events: 55 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Standard of Care
n=61 participants at risk
Subjects undergo 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. Subjects undergo laboratory biomarker analysis, including spirometry, diffusion capacity (DLCO), and lung volumes (FEV, FEV1). Subjects complete a self-assessment, RTOG defined acute evaluation toxicity evaluation, RTOG late toxicity evaluation, and constitutional assessment.
Radiation doses between 60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation schemes are utilized. Treatment volumes are at the discretion of the treating radiation oncologist and should follow standard of care.
Laboratory Biomarker Analysis: Correlative studies
Standard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
Stereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
Four Dimensional Computed Tomographic Imaging (4DCT): 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.
|
Pulmonary Function Damage Reduction
n=55 participants at risk
All criteria and specifications in the standard of care arm are applicable for this arm, including the same 4DCT scans, and laboratory biomarker analysis. Subjects randomized to this arm of the trial will have the same prescribed radiation dose to the tumor volume and held to the same radiation dose criteria as the subjects in the standard of care arm (60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation). The fundamental difference will be radiation doses for these subjects will be redistributed away from regions predicted to cause the greatest reduction in pulmonary function if damaged.
Laboratory Biomarker Analysis: Correlative studies
Standard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
Stereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
Four Dimensional Computed Tomographic Imaging (4DCT): 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.
|
|---|---|---|
|
General disorders
Death NOS
|
1.6%
1/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
1.8%
1/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Infections and infestations
Sepsis
|
1.6%
1/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
0.00%
0/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Nervous system disorders
Stroke
|
1.6%
1/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
0.00%
0/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.6%
1/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
0.00%
0/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
2/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
1.8%
1/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
1.6%
1/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
0.00%
0/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
1.8%
1/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
1.8%
1/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Infections and infestations
Lung infection
|
0.00%
0/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
1.8%
1/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Investigations
Platelet count decreased
|
0.00%
0/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
1.8%
1/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
1.8%
1/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Cardiac disorders
Heart failure
|
0.00%
0/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
1.8%
1/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
1.8%
1/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
1.8%
1/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
Other adverse events
| Measure |
Standard of Care
n=61 participants at risk
Subjects undergo 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. Subjects undergo laboratory biomarker analysis, including spirometry, diffusion capacity (DLCO), and lung volumes (FEV, FEV1). Subjects complete a self-assessment, RTOG defined acute evaluation toxicity evaluation, RTOG late toxicity evaluation, and constitutional assessment.
Radiation doses between 60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation schemes are utilized. Treatment volumes are at the discretion of the treating radiation oncologist and should follow standard of care.
Laboratory Biomarker Analysis: Correlative studies
Standard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
Stereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
Four Dimensional Computed Tomographic Imaging (4DCT): 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.
|
Pulmonary Function Damage Reduction
n=55 participants at risk
All criteria and specifications in the standard of care arm are applicable for this arm, including the same 4DCT scans, and laboratory biomarker analysis. Subjects randomized to this arm of the trial will have the same prescribed radiation dose to the tumor volume and held to the same radiation dose criteria as the subjects in the standard of care arm (60-66 Gy using standard fractionation (1.8-2.0 Gy/fx) and 40-60 Gy stereotactic body radiation therapy (SBRT) hypofractionation). The fundamental difference will be radiation doses for these subjects will be redistributed away from regions predicted to cause the greatest reduction in pulmonary function if damaged.
Laboratory Biomarker Analysis: Correlative studies
Standard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
Stereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
Four Dimensional Computed Tomographic Imaging (4DCT): 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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.0%
14/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
12.7%
7/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.1%
8/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
3.6%
2/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Gastrointestinal disorders
Esophagitis
|
24.6%
15/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
18.2%
10/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
General disorders
Rib fracture
|
6.6%
4/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
9.1%
5/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
18.0%
11/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
14.5%
8/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Respiratory, thoracic and mediastinal disorders
Other- FEV
|
37.7%
23/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
30.9%
17/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Respiratory, thoracic and mediastinal disorders
Other - DLCO
|
62.3%
38/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
50.9%
28/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Cardiac disorders
SVT arrhythmia
|
1.6%
1/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
0.00%
0/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
1.8%
1/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.7%
23/61 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
23.6%
13/55 • SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
|
Additional Information
Cancer Connect
University of Wisconsin Carbone Cancer Center
Phone: 800-622-8922
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place