{"analyses":[{"ciLowerLimit":"0.4176","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.6488","groupDescription":"Accuracy of ΔSUVmax to Predict OS at year 5 independent of treatment arm 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":"0.5332"},{"ciNumSides":"TWO_SIDED","groupDescription":"Maximum Youden index","groupIds":["OG000"],"nonInferiorityComment":"Maximum Youden index is the point value corresponding to the optimum threshold for distributional separation.\n\nYouden index (max( sensitivity + specificity-1)) over all ΔSUVmax","nonInferiorityType":"OTHER","paramType":"Youdin index","paramValue":"0.1507"},{"ciNumSides":"TWO_SIDED","groupDescription":"the optimal SUVmax threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index","groupIds":["OG000"],"nonInferiorityComment":"SUVmax @ Max(Youden index)","nonInferiorityType":"OTHER","paramType":"optimal ΔSUVmax threshold","paramValue":"-46.86"},{"ciLowerLimit":"0.2845","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.7025","groupDescription":"Accuracy of ΔSUVmax 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":"0.4935"},{"ciNumSides":"TWO_SIDED","groupDescription":"Maximum Youden index =(max( sensitivity + specificity-1)) over all ΔSUVmax","groupIds":["OG001"],"nonInferiorityComment":"Maximum Youden index is the point value corresponding to the optimum threshold for distributional separation.","nonInferiorityType":"OTHER","paramType":"Youdin index","paramValue":"0.1948"},{"ciNumSides":"TWO_SIDED","groupDescription":"the optimal SUVmax threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index","groupIds":["OG001"],"nonInferiorityComment":"SUVmax @ Max(Youden index)","nonInferiorityType":"OTHER","paramType":"optimal ΔSUVmax threshold","paramValue":"-67.5365"},{"ciLowerLimit":"0.4092","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.6937","groupDescription":"Accuracy of ΔSUVmax 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":"0.5514"},{"ciNumSides":"TWO_SIDED","groupDescription":"Maximum Youden index =(max( sensitivity + specificity-1)) over all ΔSUVmax","groupIds":["OG002"],"nonInferiorityComment":"Maximum Youden index is the point value corresponding to the optimum threshold for distributional separation.","nonInferiorityType":"OTHER","paramType":"Youdin index","paramValue":"0.1773"},{"ciNumSides":"TWO_SIDED","groupDescription":"the optimal SUVmax threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index","groupIds":["OG002"],"nonInferiorityComment":"SUVmax @ Max(Youden index)","nonInferiorityType":"OTHER","paramType":"optimal ΔSUVmax threshold","paramValue":"-46.8637"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.57","value":"-38.68"},{"groupId":"OG001","spread":"27.02","value":"-39.13"},{"groupId":"OG002","spread":"30.01","value":"-38.42"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"24"}],"units":"Participants"}],"title":"Alive"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"29.90","value":"-41.11"},{"groupId":"OG001","spread":"38.00","value":"-33.75"},{"groupId":"OG002","spread":"24.98","value":"-44.56"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"47"}],"units":"Participants"}],"title":"Event (death)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"107"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"71"}],"units":"Participants"}],"description":"FDG ΔSUVmax as measured at baseline PET imaging will be assessed in its ability to predict Overall Survival (OS) at year 5.\n\nRelative change in FDG SUVmax defined as ΔSUVmax = (during-treatment SUVmax - baseline SUVmax )/baseline SUVmax x 100%), Outcomes evaluated at 5 years. Overall Survival (OS): True if Alive 5 years from registration.","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":"Responders and non-responders are placed in separate rows. Number analyzed represents the denominator for the estimated value sum of rows = Overall Number of Participants Analyzed","reportingStatus":"POSTED","timeFrame":"Baseline to up to 5 years","title":"FDG ΔSUVmax, From Baseline to the During-treatment FDG PET/CT, to Predict OS and Optimal Threshold (ECOG-ACRIN)","type":"SECONDARY","unitOfMeasure":"percent change"}