{"analyses":[{"ciLowerLimit":"0.2650","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.7985","groupDescription":"Accuracy of HV 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":"0.5317"},{"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 HV","nonInferiorityType":"OTHER","paramType":"Youdin index","paramValue":"0.2222"},{"ciNumSides":"TWO_SIDED","groupDescription":"The optimal HV threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index","groupIds":["OG000"],"nonInferiorityComment":"HV @ Max(Youden index)","nonInferiorityType":"OTHER","paramType":"Optimal HV threshold","paramValue":"0.2650"},{"ciLowerLimit":"0.0000","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.0000","groupDescription":"Accuracy of HV 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":"0.5556"},{"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 HV","nonInferiorityType":"OTHER","paramType":"Youdin index","paramValue":"0.3333"},{"ciNumSides":"TWO_SIDED","groupDescription":"The optimal HV threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index","groupIds":["OG001"],"nonInferiorityComment":"HV @ Max(Youden index)","nonInferiorityType":"OTHER","paramType":"Optimal HV threshold","paramValue":"7.6300"},{"ciLowerLimit":"0.2271","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.8979","groupDescription":"Accuracy of HV 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":"0.5625"},{"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 HV","nonInferiorityType":"OTHER","paramType":"Youdin index","paramValue":"0.2083"},{"ciNumSides":"TWO_SIDED","groupDescription":"The optimal HV threshold for discriminating Positive and Negative cases as determined by the value having the maximum Youden index","groupIds":["OG002"],"nonInferiorityComment":"HV @ Max(Youden index)","nonInferiorityType":"OTHER","paramType":"Optimal HV threshold","paramValue":"19.5900"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"31.177","value":"18.08"},{"groupId":"OG001","spread":"15.385","value":"12.42"},{"groupId":"OG002","spread":"37.838","value":"20.91"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"6"}],"units":"Participants"}],"title":"Responder(No Event)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"96.549","value":"36.98"},{"groupId":"OG001","spread":"9.533","value":"8.27"},{"groupId":"OG002","spread":"126.530","value":"58.52"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"8"}],"units":"Participants"}],"title":"Non-Responder"}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"14"}],"units":"Participants"}],"description":"FMISO Hypoxic tumor volume @baseline, 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 HV defined as the number of pixels in the gross tumor volume with a tumor-to-blood pool ratio of \\> 1.2 in cc LCCS defined as NO Lung Cancer Cause-specific disease 5 years post registration (Responders) OT defined as the HV 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":"FMISO Hypoxic Tumor Volume (HV) @Baseline, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)","type":"SECONDARY","unitOfMeasure":"cm^3"}