{"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":"FG000","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":"FG001","title":"Chemoradiotherapy"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}],"type":"Site withdrew before starting treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Protocol Violation"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"144"},{"groupId":"FG001","numSubjects":"141"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"138"},{"groupId":"FG001","numSubjects":"135"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}]}