{"analyses":[{"groupDescription":"Assuming a two-year LRPF rate of 50% in the Standard Radiation Therapy (RT) arm and using a 2:1 randomization in favor of the Adaptive RT arm, 117 eligible patients (78 in the Adaptive RT arm and 39 in the Standard RT arm) provide 85% power to detect a 20% absolute increase in the 2-year LRPF rate at a significance level of 0.15 using a one-sided Z test for 2 proportions.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.6585","statisticalMethod":"Z-test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"37.9","upperLimit":"75.7","value":"59.5"},{"groupId":"OG001","lowerLimit":"39.9","upperLimit":"67.0","value":"54.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"84"}],"units":"Participants"}],"description":"LRPF survival is defined as survival without local-regional progression (LRP) as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria with integration of 8F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT), and reviewed centrally based on submitted CT scans. LRP is defined as any of the following:\n\n* ≥ 20% increase in any of the target lesions (primary and nodal disease),\n* ≥ 20% increase in the peak SUV of target lesions,\n* appearance of one or more new lesions within previously irradiated regions.\n\nLRPF-free survival time is defined as time from registration to the date of first local-regional progression, distant recurrence (censored), death without documented LRP (censored), or death. LRPF survival rates are estimated using the Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.","id":"OG000","title":"Standard Radiation Therapy"},{"description":"A maximum of 80.4 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel. Radiation therapy dose is individualized for final 9 fractions based on imaging results from PET/CT scan between fractions 18 and 19.","id":"OG001","title":"Adaptive Radiation Therapy"}],"paramType":"NUMBER","populationDescription":"Eligible participants","reportingStatus":"POSTED","timeFrame":"Randomization to 2 years","title":"Percentage of Participants Alive Without Local-regional Progression [Local-regional Progression-free (LRPF) Survival] at Two Years (NRG)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}