{"analyses":[{"ciLowerLimit":"0.55","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.25","estimateComment":"Hazard ratio is (Induction+CRT)/CRT","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.37","paramType":"Hazard Ratio (HR)","paramValue":"0.83","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"61.1","upperLimit":"77.5","value":"69.3"},{"groupId":"OG001","lowerLimit":"55.4","upperLimit":"72.2","value":"63.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"138"},{"groupId":"OG001","value":"135"}],"units":"Participants"}],"description":"DFFS rates over 6 years. DFFS is time from randomization to distant recurrence or death from any cause","dispersionType":"95% Confidence Interval","groups":[{"description":"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.\n\nChemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.\n\ndocetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)\n\ncisplatin: 75 mg/m2 on day 1\n\nhydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)\n\nfluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)\n\nchemotherapy: See protocol for details\n\nradiotherapy: See protocol for details","id":"OG000","title":"Induction Plus Chemoradiotherapy"},{"description":"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.\n\ndocetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)\n\nhydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)\n\nfluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)\n\nchemotherapy: See protocol for details\n\nradiotherapy: See protocol for details","id":"OG001","title":"Chemoradiotherapy"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Up to 6 years","title":"Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause","type":"SECONDARY","unitOfMeasure":"percentage of participants"}