{"analyses":[{"ciLowerLimit":"0.4179","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.6477","groupDescription":"Accuracy of ΔMTV to Predict OS 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":"0.5328"},{"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 ΔMTV","nonInferiorityType":"OTHER","paramType":"Youdin index","paramValue":"0.1468"},{"ciNumSides":"TWO_SIDED","groupDescription":"The optimal ΔMTV threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index","groupIds":["OG000"],"nonInferiorityComment":"ΔMTV @ Max(Youden index)","nonInferiorityType":"OTHER","paramType":"Optimal ΔMTV threshold","paramValue":"-41.2268"},{"ciLowerLimit":"0.3821","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.7738","groupDescription":"Accuracy of ΔMTV to Predict OS 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":"0.5779"},{"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 ΔMTV","nonInferiorityType":"OTHER","paramType":"Youdin index","paramValue":"0.2273"},{"ciNumSides":"TWO_SIDED","groupDescription":"The optimal ΔMTV threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index","groupIds":["OG001"],"nonInferiorityComment":"ΔMTV @ Max(Youden index)","nonInferiorityType":"OTHER","paramType":"Optimal ΔMTV threshold","paramValue":"-46.7619"},{"ciLowerLimit":"0.3712","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.6607","groupDescription":"Accuracy of ΔMTV to Predict OS 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":"0.5160"},{"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 ΔMTV","nonInferiorityType":"OTHER","paramType":"Youdin index","paramValue":"0.1339"},{"ciNumSides":"TWO_SIDED","groupDescription":"The optimal ΔMTV threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index","groupIds":["OG002"],"nonInferiorityComment":"ΔMTV @ Max(Youden index)","nonInferiorityType":"OTHER","paramType":"Optimal ΔMTV threshold","paramValue":"-31.8376"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"37.955","value":"-34.27"},{"groupId":"OG001","spread":"32.240","value":"-33.15"},{"groupId":"OG002","spread":"41.578","value":"-34.92"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"24"}],"units":"Participants"}],"title":"Responder(No Event)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"719.072","value":"53.59"},{"groupId":"OG001","spread":"41.755","value":"-21.60"},{"groupId":"OG002","spread":"871.545","value":"88.79"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"47"}],"units":"Participants"}],"title":"Non-Responder"}],"denoms":[{"counts":[{"groupId":"OG000","value":"107"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"71"}],"units":"Participants"}],"description":"FDG ΔMTV, as measured from Baseline to the During-treatment FDG PET/CT, will be assessed in its ability to predict Overall Survival (OS) and an Optimal Threshold (OT) for differentiating responders from non-responders will be identified FDG ΔMTV defined as ((during-treatment measure - baseline measure)/baseline measure) x 100%) OS defined as Alive 5 years post registration (Responders) OT defined as the ΔMTV 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 ΔMTV From Baseline to the During-treatment FDG PET/CT, to Predict Overall Survival and Optimal Threshold (ECOG-ACRIN)","type":"SECONDARY","unitOfMeasure":"percent change"}