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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01085 | Registry Identifier | NCI Trial ID | |
| UW16037 | Other Identifier | OnCore ID | |
| A539933 | Other Identifier | UW Madison | |
| SMPH\VOLUNTEER STAFF\HUM ONCOL | Other Identifier | UW Madison | |
| Protocol Version 6/9/2022 | Other Identifier | UW Madison | |
| R01CA166703 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | 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. |
|
| Pulmonary Function Damage Reduction | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months post RT |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During therapy to 12 months post-RT |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Inflammation Markers | All statistical tests will be two-sided and assessed for significance at the 5% level. Analysis is exploratory and compares pre-treatment versus post-treatment for the entire population. | Baseline to 3 months following radiation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carri K Glide-Hurst, PhD, DABR, FAAPM | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Johnson Creek | Johnson Creek | Wisconsin | 53038 | United States | ||
| University of Wisconsin Carbone Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38387810 | Result | Baschnagel AM, Flakus MJ, Wallat EM, Wuschner AE, Chappell RJ, Bayliss RA, Kimple RJ, Christensen GE, Reinhardt JM, Bassetti MF, Bayouth JE. A Phase 2 Randomized Clinical Trial Evaluating 4-Dimensional Computed Tomography Ventilation-Based Functional Lung Avoidance Radiation Therapy for Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2024 Aug 1;119(5):1393-1402. doi: 10.1016/j.ijrobp.2024.02.019. Epub 2024 Feb 20. |
| Label | URL |
|---|---|
| UW Carbone Cancer Center Home Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Evaluable for Primary Analysis
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Median | Full Range | ratio | 3 months post RT |
|
SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death NOS | General disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cancer Connect | University of Wisconsin Carbone Cancer Center | 800-622-8922 | clinicaltrials@cancer.wisc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2022 | Oct 26, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011827 | Radiation |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
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| Standard fractionation | Radiation | 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments |
|
|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments |
|
|
| Four Dimensional Computed Tomographic Imaging (4DCT) | Procedure | 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. |
|
|
| 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. | 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. | During therapy to 12 months post-RT |
| Temporal Changes in Increased Elasticity Determined by the Volume of Lung Where Expansion is Improved (Ratio) | 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. | 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. | 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. | 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. | 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. | 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. | Up to 12 months post-RT |
| Madison |
| Wisconsin |
| 53792 |
| United States |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | 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. | patients were lost to follow up and therefore data does not exist on a subset of patients | Posted | Median | Full Range | percent | During therapy to 12 months post-RT |
|
|
|
|
| Secondary | 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. | patients were lost to follow up and therefore data does not exist on a subset of patients | Posted | Median | Full Range | ratio | During therapy to 12 months post-RT |
|
|
|
|
| Secondary | 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. | patients were lost to follow up and therefore data does not exist on a subset of patients | Posted | Median | Full Range | percent | During therapy to 12 months post-RT |
|
|
|
|
| Secondary | Temporal Changes in Increased Elasticity Determined by the Volume of Lung Where Expansion is Improved (Ratio) | 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. | patients were lost to follow up and therefore data does not exist on a subset of patients | Posted | Median | Full Range | ratio | During therapy to 12 months post-RT |
|
|
|
|
| Secondary | 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. | patients were lost to follow up and therefore data does not exist on a subset of patients | Posted | Median | Full Range | percent | During therapy to 12 months post-RT |
|
|
|
|
| Secondary | 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. | patients were lost to follow up and therefore data does not exist on a subset of patients | Posted | Median | Full Range | ratio | During therapy to 12 months post-RT |
|
|
|
|
| Secondary | 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. | This measures a change from baseline, not all participants completed all time points | Posted | Median | Full Range | percent predicted | Pre-RT up to 12 months post-RT |
|
|
|
| Secondary | 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. | Raw data was collected from participants, but the processed output data needed to run the analysis does not exist, cannot be produced at this institution, and will not be processed. The investigator left the institution along with the ability to process the 4DCTs and generate the data needed to answer the objective. | Posted | Up to 12 months post-RT |
|
|
| Secondary | 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. | Raw data was collected from participants, but the processed output data needed to run the analysis does not exist, cannot be produced at this institution, and will not be processed. The investigator left the institution along with the ability to process the 4DCTs and generate the data needed to answer the objective. | Posted | Up to 12 months post-RT |
|
|
| Other Pre-specified | Change in Blood Inflammation Markers | All statistical tests will be two-sided and assessed for significance at the 5% level. Analysis is exploratory and compares pre-treatment versus post-treatment for the entire population. | Not Posted | Baseline to 3 months following radiation | Participants |
| 3 |
| 61 |
| 7 |
| 61 |
| 61 |
| 61 |
| EG001 | 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. | 3 | 55 | 10 | 55 | 55 | 55 |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Stroke | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Heart failure | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rib fracture | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other- FEV | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other - DLCO | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| SVT arrhythmia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D019635 |
| Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| t-test, 2 sided |
| 0.34 |
| Equivalence |
assessed for significance at the 5% level |
| t-test, 2 sided |
| 0.71 |
| Equivalence |
assessed for significance at the 5% level |
| t-test, 2 sided |
| 0.66 |
| Equivalence |
assessed for significance at the 5% level |
| t-test, 2 sided |
| 0.66 |
| Equivalence |
assessed for significance at the 5% level |
| t-test, 2 sided |
| 0.64 |
| Equivalence |
assessed for significance at the 5% level |
| t-test, 2 sided |
| 0.44 |
| Equivalence |
assessed for significance at the 5% level |
|
| Median Absolute Change in the FEV1 percent predicted from baseline to 6 months |
|
|
| Median Absolute Change in the FEV1 percent predicted from baseline to 12 months |
|
|
| Median Absolute Change in the FVC percent predicted from baseline to 3 months |
|
|
| Median Absolute Change in the FVC percent predicted from baseline to 6 months |
|
|
| Median Absolute Change in the FVC percent predicted from baseline to 12 months |
|
|
| Median Absolute Change in the DLCO percent predicted from baseline to 3 months |
|
|
| Median Absolute Change in the DLCO percent predicted from baseline to 6 months |
|
|
| Median Absolute Change in the DLCO percent predicted from baseline to 12 months |
|
|