{"analyses":[{"ciLowerLimit":"0.3451","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.5702","groupDescription":"Accuracy of ΔSUVpeak to Predict LCCS at year 5 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":"0.4576"},{"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 ΔSUVpeak","nonInferiorityType":"OTHER","paramType":"Youdin index","paramValue":"0.0858"},{"ciNumSides":"TWO_SIDED","groupDescription":"The optimal ΔSUVpeak threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index","groupIds":["OG000"],"nonInferiorityComment":"ΔSUVpeak @ Max(Youden index)","nonInferiorityType":"OTHER","paramType":"Optimal ΔSUVpeak threshold","paramValue":"-16.7768"},{"ciLowerLimit":"0.3126","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.7124","groupDescription":"Accuracy of ΔSUVpeak to Predict LCCS at year 5 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":"0.5125"},{"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 ΔSUVpeak","nonInferiorityType":"OTHER","paramType":"Youdin index","paramValue":"0.2000"},{"ciNumSides":"TWO_SIDED","groupDescription":"The optimal ΔSUVpeak threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index","groupIds":["OG001"],"nonInferiorityComment":"ΔSUVpeak @ Max(Youden index)","nonInferiorityType":"OTHER","paramType":"Optimal ΔSUVpeak threshold","paramValue":"-71.4286"},{"ciLowerLimit":"0.3115","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.5908","groupDescription":"Accuracy of ΔSUVpeak to Predict LCCS at year 5 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":"0.4511"},{"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 ΔSUVpeak","nonInferiorityType":"OTHER","paramType":"Youdin index","paramValue":"0.1106"},{"ciNumSides":"TWO_SIDED","groupDescription":"The optimal ΔSUVpeak threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index","groupIds":["OG002"],"nonInferiorityComment":"ΔSUVpeak @ Max(Youden index)","nonInferiorityType":"OTHER","paramType":"Optimal ΔSUVpeak threshold","paramValue":"-14.9523"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"49.018","value":"-39.15"},{"groupId":"OG001","spread":"25.898","value":"-42.35"},{"groupId":"OG002","spread":"57.536","value":"-37.55"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"32"}],"units":"Participants"}],"title":"Responder(No Event)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.651","value":"-40.34"},{"groupId":"OG001","spread":"35.710","value":"-34.88"},{"groupId":"OG002","spread":"22.486","value":"-43.15"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"39"}],"units":"Participants"}],"title":"Non-Responder"}],"denoms":[{"counts":[{"groupId":"OG000","value":"107"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"71"}],"units":"Participants"}],"description":"FDG ΔSUVpeak, as measured from Baseline to the During-treatment FDG PET/CT, will be assessed in its ability to predict Lung Cancer Cause-specific Survival (LCCS) and an Optimal Threshold (OT) for differentiating responders from non-responders will be identified ΔSUVpeak defined as ((during-treatment measure - baseline measure)/baseline measure) x 100%) LCCS defined as NO Lung Cancer Cause-specific disease 5 years post registration (Responders) OT defined as the ΔSUVpeak 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 ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)","type":"SECONDARY","unitOfMeasure":"percent change"}