{"analyses":[{"ciLowerLimit":"0.2196","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.8915","groupDescription":"Accuracy of HV to Predict LRPF at year 2 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":"0.5556"},{"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":"0.2333"},{"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":"2.7500"},{"ciLowerLimit":"0.0000","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.0000","groupDescription":"Accuracy of HV to Predict LRPF at year 2 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":"0.5000"},{"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":"0.5000"},{"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":"26.8500"},{"ciLowerLimit":"0.1842","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.9067","groupDescription":"Accuracy of HV to Predict LRPF at year 2 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":"0.5455"},{"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":"0.3636"},{"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":"22.9100"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.104","value":"10.87"},{"groupId":"OG001","spread":"20.952","value":"14.82"},{"groupId":"OG002","spread":"9.901","value":"8.24"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"}],"units":"Participants"}],"title":"Responder(No Event)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"86.769","value":"34.79"},{"groupId":"OG001","spread":"8.706","value":"8.18"},{"groupId":"OG002","spread":"109.282","value":"51.72"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"11"}],"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 (HV) @baseline, will be assessed in its ability to predict Local-Regional Progression-Free (LRPF) and an Optimal Threshold (OT) for differentiating responders from non-responders will be identified HV defined as the number of pixels in the grLRPFs tumor volume with a tumor-to-blood pool ratio of \\> 1.2 in cc LRPF defined as as NO progressive lung cancer within 1 cm from the planning target volume.or Progressive disease in any of the 14 nodal stations beyond 1cm 2 Years from regitration (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 @Baseline, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)","type":"SECONDARY","unitOfMeasure":"cm^3"}