Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-02-26 @ 7:25 PM
Study NCT ID:
NCT02843568
Status:
COMPLETED
Last Update Posted:
2024-10-10
First Post:
2016-07-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Pulmonary Function Following Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011827', 'term': 'Radiation'}, {'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@cancer.wisc.edu', 'phone': '800-622-8922', 'title': 'Cancer Connect', 'organization': 'University of Wisconsin Carbone Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'SAEs were collected for 3 months, Other Adverse Events were collected for 12 months, All Cause mortality was collected for 30 days post-RT', 'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care', 'description': '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.\n\nRadiation 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.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nStandard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments\n\nStereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments\n\nFour 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.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 61, 'seriousNumAtRisk': 61, 'deathsNumAffected': 3, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Pulmonary Function Damage Reduction', 'description': '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.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nStandard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments\n\nStereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments\n\nFour 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.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 55, 'seriousNumAtRisk': 55, 'deathsNumAffected': 3, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other- FEV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other - DLCO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'SVT arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pulmonary Function, Based on Changes in Tissue Elasticity Measured From 4DCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': '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.\n\nRadiation 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.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nStandard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments\n\nStereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments\n\nFour 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.'}, {'id': 'OG001', 'title': 'Pulmonary Function Damage Reduction', 'description': '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.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nStandard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments\n\nStereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments\n\nFour 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.09', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '2.8'}, {'value': '1.13', 'groupId': 'OG001', 'lowerLimit': '0.37', 'upperLimit': '3.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months post RT', 'description': '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).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Temporal Changes in Reduced Elasticity Determined by the Volume of Lung Where Expansion is Improved', 'timeFrame': 'During therapy to 12 months post-RT', 'description': 'All statistical tests will be two-sided and assessed for significance at the 5% level.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-04'}, {'type': 'SECONDARY', 'title': 'Temporal Changes in Increased Elasticity Determined by the Volume of Lung Where Expansion is Improved', 'timeFrame': 'During therapy to 12 months post-RT', 'description': 'All statistical tests will be two-sided and assessed for significance at the 5% level.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-04'}, {'type': 'SECONDARY', 'title': 'Temporal Changes in Fraction of Expanding Lung Determined by the Volume of Lung Where "Meaningful" Expansion Occurs', 'timeFrame': 'During therapy to 12 months post-RT', 'description': 'All statistical tests will be two-sided and assessed for significance at the 5% level.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-04'}, {'type': 'SECONDARY', 'title': 'Validation in Consistency of Tissue Elasticity Changes Measured With Values Predicted Based on Existing Radiation Dose Response Curves', 'timeFrame': 'Up to 12 months post-RT', 'description': 'All statistical tests will be two-sided and assessed for significance at the 5% level.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-04'}, {'type': 'SECONDARY', 'title': 'Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care: Conventionally Fractionated Cohort', 'description': 'Standard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments'}, {'id': 'OG001', 'title': 'Pulmonary Function Damage Reduction: Conventionally Fractionated Cohort', 'description': 'Standard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments'}, {'id': 'OG002', 'title': 'Standard of Care: SBRT Cohort', 'description': 'Participants undergoing stereotactic body radiation therapy (SBRT) 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments'}, {'id': 'OG003', 'title': 'Pulmonary Function Damage Reduction: SBRT Cohort', 'description': 'Participants undergoing Stereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments'}], 'classes': [{'title': 'Median Absolute Change in the FEV1 percent predicted from baseline to 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG000', 'lowerLimit': '-28', 'upperLimit': '10'}, {'value': '-3', 'groupId': 'OG001', 'lowerLimit': '-12', 'upperLimit': '46'}, {'value': '-2', 'groupId': 'OG002', 'lowerLimit': '-15', 'upperLimit': '10'}, {'value': '-2', 'groupId': 'OG003', 'lowerLimit': '-21', 'upperLimit': '18'}]}]}, {'title': 'Median Absolute Change in the FEV1 percent predicted from baseline to 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4', 'groupId': 'OG000', 'lowerLimit': '-32', 'upperLimit': '14'}, {'value': '-4', 'groupId': 'OG001', 'lowerLimit': '-15', 'upperLimit': '13'}, {'value': '-2', 'groupId': 'OG002', 'lowerLimit': '-31', 'upperLimit': '13'}, {'value': '-3', 'groupId': 'OG003', 'lowerLimit': '-24', 'upperLimit': '19'}]}]}, {'title': 'Median Absolute Change in the FEV1 percent predicted from baseline to 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '-26', 'upperLimit': '23'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '-36', 'upperLimit': '25'}, {'value': '-2', 'groupId': 'OG002', 'lowerLimit': '-18', 'upperLimit': '12'}, {'value': '-1', 'groupId': 'OG003', 'lowerLimit': '-29', 'upperLimit': '18'}]}]}, {'title': 'Median Absolute Change in the FVC percent predicted from baseline to 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6', 'groupId': 'OG000', 'lowerLimit': '-34', 'upperLimit': '11'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '-15', 'upperLimit': '28'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '-15', 'upperLimit': '30'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '-20', 'upperLimit': '24'}]}]}, {'title': 'Median Absolute Change in the FVC percent predicted from baseline to 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.5', 'groupId': 'OG000', 'lowerLimit': '-35', 'upperLimit': '20'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-21', 'upperLimit': '27'}, {'value': '-0.5', 'groupId': 'OG002', 'lowerLimit': '-41', 'upperLimit': '30'}, {'value': '-2', 'groupId': 'OG003', 'lowerLimit': '-18', 'upperLimit': '20'}]}]}, {'title': 'Median Absolute Change in the FVC percent predicted from baseline to 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG000', 'lowerLimit': '-20', 'upperLimit': '29'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '-36', 'upperLimit': '21'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '-19', 'upperLimit': '15'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '-26', 'upperLimit': '27'}]}]}, {'title': 'Median Absolute Change in the DLCO percent predicted from baseline to 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-12', 'groupId': 'OG000', 'lowerLimit': '-57', 'upperLimit': '12'}, {'value': '-11', 'groupId': 'OG001', 'lowerLimit': '-29', 'upperLimit': '4'}, {'value': '-2.5', 'groupId': 'OG002', 'lowerLimit': '-21', 'upperLimit': '33'}, {'value': '-2', 'groupId': 'OG003', 'lowerLimit': '-52', 'upperLimit': '22'}]}]}, {'title': 'Median Absolute Change in the DLCO percent predicted from baseline to 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-11', 'groupId': 'OG000', 'lowerLimit': '-62', 'upperLimit': '15'}, {'value': '-9.5', 'groupId': 'OG001', 'lowerLimit': '-33', 'upperLimit': '7'}, {'value': '-6.5', 'groupId': 'OG002', 'lowerLimit': '-31', 'upperLimit': '15'}, {'value': '-0.5', 'groupId': 'OG003', 'lowerLimit': '-43', 'upperLimit': '24'}]}]}, {'title': 'Median Absolute Change in the DLCO percent predicted from baseline to 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '-24', 'upperLimit': '48'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '-9', 'upperLimit': '43'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '-37', 'upperLimit': '48'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '-36', 'upperLimit': '55'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-RT up to 12 months post-RT', 'description': '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.', 'unitOfMeasure': 'percent predicted', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This measures a change from baseline, not all participants completed all time points'}, {'type': 'SECONDARY', 'title': 'Change in Level of Plasma TGF-beta', 'timeFrame': 'Baseline up to 12 months post-RT', 'description': 'All statistical tests will be two-sided and assessed for significance at the 5% level.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-04'}, {'type': 'SECONDARY', 'title': 'Change in Level of Plasma Cytokines', 'timeFrame': 'Baseline up to 12 months post-RT', 'description': 'All statistical tests will be two-sided and assessed for significance at the 5% level.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-04'}, {'type': 'SECONDARY', 'title': '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', 'timeFrame': 'Up to 12 months post-RT', 'description': 'All statistical tests will be two-sided and assessed for significance at the 5% level.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-04'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care', 'description': '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.\n\nRadiation 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.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nStandard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments\n\nStereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments\n\nFour 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.'}, {'id': 'FG001', 'title': 'Pulmonary Function Damage Reduction', 'description': '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.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nStandard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments\n\nStereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments\n\nFour 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'Evaluable for Primary Analysis', 'comment': 'Participants were excluded as they had a change in treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'SBRT Cohort (Analyzed for Toxicities)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Conventional Cohort (Analyzed for Toxicities)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Participants at 3 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'Participants at 6 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Participants at 12 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Analyzed for Primary Endpoints', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Excluded from Primary Population due to change in treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care', 'description': '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.\n\nRadiation 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.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nStandard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments\n\nStereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments\n\nFour 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.'}, {'id': 'BG001', 'title': 'Pulmonary Function Damage Reduction', 'description': '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.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nStandard fractionation: 60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments\n\nStereotactic Body Radiation Therapy (SBRT): 40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments\n\nFour 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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'median age', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '89'}, {'value': '71', 'groupId': 'BG001', 'lowerLimit': '52', 'upperLimit': '88'}, {'value': '70', 'groupId': 'BG002', 'lowerLimit': '49', 'upperLimit': '89'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Evaluable for Primary Analysis'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-09', 'size': 1129104, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-26T15:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2016-07-15', 'resultsFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2016-07-20', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-08', 'studyFirstPostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary Function, Based on Changes in Tissue Elasticity Measured From 4DCT', 'timeFrame': '3 months post RT', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Temporal Changes in Reduced Elasticity Determined by the Volume of Lung Where Expansion is Improved', 'timeFrame': 'During therapy to 12 months post-RT', 'description': 'All statistical tests will be two-sided and assessed for significance at the 5% level.'}, {'measure': 'Temporal Changes in Increased Elasticity Determined by the Volume of Lung Where Expansion is Improved', 'timeFrame': 'During therapy to 12 months post-RT', 'description': 'All statistical tests will be two-sided and assessed for significance at the 5% level.'}, {'measure': 'Temporal Changes in Fraction of Expanding Lung Determined by the Volume of Lung Where "Meaningful" Expansion Occurs', 'timeFrame': 'During therapy to 12 months post-RT', 'description': 'All statistical tests will be two-sided and assessed for significance at the 5% level.'}, {'measure': 'Validation in Consistency of Tissue Elasticity Changes Measured With Values Predicted Based on Existing Radiation Dose Response Curves', 'timeFrame': 'Up to 12 months post-RT', 'description': 'All statistical tests will be two-sided and assessed for significance at the 5% level.'}, {'measure': 'Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs)', 'timeFrame': 'Pre-RT up to 12 months post-RT', 'description': '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.'}, {'measure': 'Change in Level of Plasma TGF-beta', 'timeFrame': 'Baseline up to 12 months post-RT', 'description': 'All statistical tests will be two-sided and assessed for significance at the 5% level.'}, {'measure': 'Change in Level of Plasma Cytokines', 'timeFrame': 'Baseline up to 12 months post-RT', 'description': 'All statistical tests will be two-sided and assessed for significance at the 5% level.'}, {'measure': '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', 'timeFrame': 'Up to 12 months post-RT', 'description': 'All statistical tests will be two-sided and assessed for significance at the 5% level.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '38387810', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://cancer.wisc.edu/', 'label': 'UW Carbone Cancer Center Home Page'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologic diagnosis of non-small cell lung cancer or lung metastasis from a solid tumor. One biopsy site is adequate for multiple sites of thoracic disease.\n* Treatment includes localized radiation therapy with or without chemotherapy\n* Karnofsky ≥ 60%\n* Not pregnant per radiation oncology standard procedures\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Prior (within last 6 months) or future planned therapeutic surgery for the treatment of the existing lung cancer\n* Prior thoracic radiotherapy\n* Severe COPD defined as disease requiring an inpatient stay for respiratory deterioration within the past 3 months\n* Oxygen dependence of \\> 2 L/min continuously throughout the day at baseline\n* Known underlying collagen vascular disease or intrinsic lung disease that could complicate expected sequelae of radiation (idiopathic pulmonary fibrosis, Wegener's granulomatosis)\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements."}, 'identificationModule': {'nctId': 'NCT02843568', 'briefTitle': 'Improving Pulmonary Function Following Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Improving Pulmonary Function Following Radiation Therapy', 'orgStudyIdInfo': {'id': 'UW16037'}, 'secondaryIdInfos': [{'id': 'NCI-2016-01085', 'type': 'REGISTRY', 'domain': 'NCI Trial ID'}, {'id': '2016-0610', 'type': 'OTHER', 'domain': 'Institutional Review Board'}, {'id': 'A539933', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH\\VOLUNTEER STAFF\\HUM ONCOL', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 6/9/2022', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'R01CA166703', 'link': 'https://reporter.nih.gov/quickSearch/R01CA166703', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': '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.\n\nRadiation 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.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Radiation: Standard fractionation', 'Radiation: Stereotactic Body Radiation Therapy (SBRT)', 'Procedure: Four Dimensional Computed Tomographic Imaging (4DCT)']}, {'type': 'EXPERIMENTAL', 'label': 'Pulmonary Function Damage Reduction', 'description': '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.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Radiation: Standard fractionation', 'Radiation: Stereotactic Body Radiation Therapy (SBRT)', 'Procedure: Four Dimensional Computed Tomographic Imaging (4DCT)']}], 'interventions': [{'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Pulmonary Function Damage Reduction', 'Standard of Care']}, {'name': 'Standard fractionation', 'type': 'RADIATION', 'otherNames': ['Cancer Radiotherapy', 'Radiation'], 'description': '60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments', 'armGroupLabels': ['Pulmonary Function Damage Reduction', 'Standard of Care']}, {'name': 'Stereotactic Body Radiation Therapy (SBRT)', 'type': 'RADIATION', 'otherNames': ['SBRT', 'Cancer Radiotherapy', 'Radiation'], 'description': '40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments', 'armGroupLabels': ['Pulmonary Function Damage Reduction', 'Standard of Care']}, {'name': 'Four Dimensional Computed Tomographic Imaging (4DCT)', 'type': 'PROCEDURE', 'otherNames': ['4DCT'], 'description': '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.', 'armGroupLabels': ['Pulmonary Function Damage Reduction', 'Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53038', 'city': 'Johnson Creek', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'UW Johnson Creek', 'geoPoint': {'lat': 43.07611, 'lon': -88.77427}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Carbone Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Carri K Glide-Hurst, PhD, DABR, FAAPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}