{"analyses":[{"ciLowerLimit":"0.83","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.28","estimateComment":"Adjusted Hazard Ratio, ECF vs 5-FU/LV","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Cox Proportional Hazard","paramValue":"1.03"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.9","upperLimit":"3.8","value":"2.7"},{"groupId":"OG001","lowerLimit":"1.5","upperLimit":"3.1","value":"2.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"280"},{"groupId":"OG001","value":"266"}],"units":"Participants"}],"description":"Disease free survival is defined as the time from the date of study enrollment to death or documented second primary tumor, or cancer recurrence.The distribution of disease free survival time will be estimated using the method of Kaplan-Meier.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive leucovorin calcium (LV) IV (20 mg/m\\^2 per day) and fluorouracil (5-FU) IV (425 mg/m\\^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.","id":"OG000","title":"Arm I (5-FU/LV)"},{"description":"Patients receive epirubicin IV (50 mg/m\\^2) over 3-15 minutes and cisplatin IV (60 mg/m\\^2) over 1 hour on day 1 and 5-FU IV (200 mg/m\\^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.","id":"OG001","title":"Arm II (ECF)"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"From the date of study enrollment until death or documented second primary tumor, or cancer recurrence; up to 4 years","title":"Disease Free Survival","type":"SECONDARY","unitOfMeasure":"years"}