{"analyses":[{"ciNumSides":"TWO_SIDED","groupDescription":"Assess Baseline Tumor Hypoxic volume(HV) Association With LRPF using Hazard ratios along with the associated p-values to compare arms","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.4235","paramType":"Hazard Ratio (HR)","paramValue":"1.002","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"77.14","value":"29.59"},{"groupId":"OG001","spread":"10.97","value":"9.65"},{"groupId":"OG002","spread":"97.70","value":"42.40"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"14"}],"units":"Participants"}],"description":"Tumor Hypoxic Volume (PET-MISO measure) is defined as the number of pixels in the gross tumor volume with a tumor-to-blood pool ratio of \\> 1.2, Association With LRPF 2-years Post 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":"Participants enrolled at an institution participating in the FMISO Correlative Study. Note that the company supplying FMISO ceased production early in the study.","reportingStatus":"POSTED","timeFrame":"Baseline and 2-years after randomization","title":"Baseline 18F-fluoromisonidazole (FMISO) Tumor Hypoxic Volume Association With LRPF 2-years Post Registration (ECOG-ACRIN)","type":"SECONDARY","unitOfMeasure":"cm^3"}