{"analyses":[{"ciLowerLimit":"0.5330","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.8022","groupDescription":"Accuracy of SUVmax @ Baseline to Predict LRPF at year 2 as measured by the Area under the ROC curve (AUC/c-statistic) and Optimal Threshold separating responders and non-responders as measured by the Youden index","groupIds":["OG000"],"nonInferiorityComment":"The AUC/C-statistic is a measure of discrimination between responders and non-responders","nonInferiorityType":"OTHER","paramType":"AUC","paramValue":"0.6676"},{"ciNumSides":"TWO_SIDED","groupDescription":"Maximum Youden index","groupIds":["OG000"],"nonInferiorityComment":"Maximum Youden index is the point value corresponding tothe optimum threshold for distributional separation.\n\nYouden index (max( sensitivity + specificity-1)) over all SUVmax @ Baseline","nonInferiorityType":"OTHER","paramType":"Youdin index","paramValue":"0.4105"},{"ciNumSides":"TWO_SIDED","groupDescription":"The optimal SUVmax @ Baseline threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index","groupIds":["OG000"],"nonInferiorityComment":"SUVmax @ Baseline @ Max(Youden index)","nonInferiorityType":"OTHER","paramType":"Optimal SUVmax @ Baseline threshold","paramValue":"21.6300"},{"ciLowerLimit":"0.5183","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.9192","groupDescription":"Accuracy of SUVmax @ Baseline to Predict LRPF at year 2 as measured by the Area under the ROC curve (AUC/c-statistic) and Optimal Threshold separating responders and non-responders as measured by the Youden index","groupIds":["OG001"],"nonInferiorityComment":"The AUC/C-statistic is a measure of discrimination between responders and non-responders","nonInferiorityType":"OTHER","paramType":"AUC","paramValue":"0.7188"},{"ciNumSides":"TWO_SIDED","groupDescription":"Maximum Youden index","groupIds":["OG001"],"nonInferiorityComment":"Maximum Youden index is the point value corresponding tothe optimum threshold for distributional separation.\n\nYouden index (max( sensitivity + specificity-1)) over all SUVmax @ Baseline","nonInferiorityType":"OTHER","paramType":"Youdin index","paramValue":"0.5625"},{"ciNumSides":"TWO_SIDED","groupDescription":"The optimal SUVmax @ Baseline threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index","groupIds":["OG001"],"nonInferiorityComment":"SUVmax @ Baseline @ Max(Youden index)","nonInferiorityType":"OTHER","paramType":"Optimal SUVmax @ Baseline threshold","paramValue":"21.2400"},{"ciLowerLimit":"0.4281","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.8100","groupDescription":"Accuracy of SUVmax @ Baseline to Predict LRPF at year 2 as measured by the Area under the ROC curve (AUC/c-statistic) and Optimal Threshold separating responders and non-responders as measured by the Youden index","groupIds":["OG002"],"nonInferiorityComment":"The AUC/C-statistic is a measure of discrimination between responders and non-responders","nonInferiorityType":"OTHER","paramType":"AUC","paramValue":"0.6190"},{"ciNumSides":"TWO_SIDED","groupDescription":"Maximum Youden index","groupIds":["OG002"],"nonInferiorityComment":"Maximum Youden index is the point value corresponding tothe optimum threshold for distributional separation.\n\nYouden index (max( sensitivity + specificity-1)) over all SUVmax @ Baseline","nonInferiorityType":"OTHER","paramType":"Youdin index","paramValue":"0.3189"},{"ciNumSides":"TWO_SIDED","groupDescription":"The optimal SUVmax @ Baseline threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index","groupIds":["OG002"],"nonInferiorityComment":"SUVmax @ Baseline @ Max(Youden index)","nonInferiorityType":"OTHER","paramType":"Optimal SUVmax @ Baseline threshold","paramValue":"20.8500"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.966","value":"21.44"},{"groupId":"OG001","spread":"6.810","value":"22.10"},{"groupId":"OG002","spread":"7.368","value":"20.96"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"11"}],"units":"Participants"}],"title":"Responder(No Event)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.355","value":"17.82"},{"groupId":"OG001","spread":"8.296","value":"15.86"},{"groupId":"OG002","spread":"9.762","value":"18.82"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"63"}],"units":"Participants"}],"title":"Non-Responder"}],"denoms":[{"counts":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"74"}],"units":"Participants"}],"description":"SUVmax, as measured at Baseline, will be assessed in its ability to predict Local-Regional Progression-Free(LRPF) and an Optimal Threshold (OT) for differentiating responders from non-responders will be identified LRPF defined as as NO progressive lung cancer within 1 cm from the planning target volume.or Progressive disease in any of the 14 nodal stations beyond 1cm 2 Years from regitration (Responders) OT defined as the SUVmax value corresponding to the maximum Youden index","dispersionType":"Standard Deviation","groups":[{"description":"Patients undergo chemoradiotherapy as defined for the arm of the study to which they were randomized.\n\n18F-Fluoromisonidazole: Undergo FMISO PET/CT prior to therapy for patients enrolling at institutions participating in the FMISO correlative study","id":"OG000","title":"Both Arms"},{"description":"Patients undergo standard radiotherapy QD 5 days a week for 30 fractions. Patients also receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for 6 weeks. Patients undergo FMISO-PET imaging at baseline\n\n18F-Fluoromisonidazole: Undergo FMISO PET/CT prior to therapy for patients enrolling at institutions participating in the FMISO correlative study\n\nCarboplatin: Given IV\n\nExternal Beam Radiation Therapy: Undergo radiotherapy","id":"OG001","title":"Arm I (Standard Chemoradiotherapy)"},{"description":"Patients undergo an individualized dose of image-guided radiotherapy QD 5 days a week for 30 fractions and undergo 18 F FDG-PET/CT between fractions 18 and 19. Based on the scan results, patients undergo individualized adaptive radiotherapy for the final 9 fractions. Patients also receive paclitaxel and carboplatin as in Arm I.\n\n18F-Fluoromisonidazole: Participants enrolled at institutions participating in the FMISO correlative study undergo FMISO-PET prior to treatment\n\nCarboplatin: Given IV\n\nComputed Tomography: Undergo FDG PET/CT\n\nComputed Tomography: Undergo FMISO PET/CT (Correlative studies)\n\nFludeoxyglucose F-18: Undergo FDG PET/CT\n\nImage-Guided Adaptive Radiation Therapy: Undergo individualized adaptive radiotherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPaclitaxel: Given IV\n\nPositron Emission Tomography: Undergo FDG PET/CT\n\nPositron Emission Tomography: Undergo FMISO PET/CT (Correlative studies)","id":"OG002","title":"Arm II (Experimental Chemoradiotherapy)"}],"paramType":"MEAN","populationDescription":"Number analyzed represents the denominator for the estimated value The sum of rows = Overall Number of Participants Analyzed","reportingStatus":"POSTED","timeFrame":"Baseline to up to 5 years","title":"FDG SUVmax @ Baseline FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)","type":"SECONDARY","unitOfMeasure":"SUV"}