{"analyses":[{"ciLowerLimit":"0.4690","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.6962","groupDescription":"Accuracy of SUVmax at Baseline 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","nonInferiorityType":"OTHER","paramType":"AUC","paramValue":"0.5826"},{"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.","nonInferiorityType":"OTHER","paramType":"Youdin index","paramValue":"0.2162"},{"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 SUVmax threshold","paramValue":"20.85"},{"ciLowerLimit":".5668","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.9159","groupDescription":"Accuracy of SUVmax at Baseline to Predict OS at year 5 in the Standard Therapy Arm as measured by the Area Under the ROC Curve (AUC/c-statistic) and the Optimal Threshold (cut-point) for 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","otherAnalysisDescription":"The optimal threshold for discriminating Positive and Negative cases in the Standard Therapy Arm occurs when baseline SUVmax = 18.27 corresponding to a Youden index (max( sensitivity + specificity-1)) of 0.5333","paramType":"AUC","paramValue":"0.7413"},{"ciNumSides":"TWO_SIDED","groupDescription":"Maximum Youden index","groupIds":["OG001"],"nonInferiorityComment":"Maximum Youden index is the point value corresponding to the optimum threshold for distributional separation","nonInferiorityType":"OTHER","paramType":"[Youdin index","paramValue":"0.5333"},{"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 SUVmax threshold","paramValue":"18.27"},{"ciLowerLimit":"0.3227","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.6218","groupDescription":"Accuracy of SUVmax at Baseline to Predict OS at year 5 in the Experimental Chemoradiotherapy Arm as measured by the Area Under the ROC Curve (AUC/c-statistic) and the Optimal Threshold (cut-point) for 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","otherAnalysisDescription":"The optimal threshold for discriminating Positive and Negative cases in the Standard Therapy Arm occurs when baseline SUVmax = 20.85 corresponding to a Youden index (max( sensitivity + specificity-1)) of 0.0931","paramType":"AUC","paramValue":"0.4722"},{"ciNumSides":"TWO_SIDED","groupDescription":"Maximum Youden index","groupIds":["OG002"],"nonInferiorityComment":"Maximum Youden index is the point value corresponding to the optimum threshold for distributional separation.","nonInferiorityType":"OTHER","paramType":"Youdin index","paramValue":"0.0931"},{"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 SUVmax threshold","paramValue":"20.85"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.36","value":"19.85"},{"groupId":"OG001","spread":"7.34","value":"21.00"},{"groupId":"OG002","spread":"10.47","value":"19.16"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"25"}],"units":"Participants"}],"title":"Alive"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"8.89","value":"17.66"},{"groupId":"OG001","spread":"8.14","value":"14.78"},{"groupId":"OG002","spread":"8.97","value":"19.12"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"49"}],"units":"Participants"}],"title":"Event (death)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"74"}],"units":"Participants"}],"description":"FDG SUVmax as measured at baseline PET imaging will be assessed in its ability to predict Overall Survival (OS) at year 5.","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":"SUVmax at Baseline Prediction of OS and Optimal Threshold (ECOG-ACRIN)","type":"SECONDARY","unitOfMeasure":"SUV"}