{"groups":[{"description":"Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone.\n\nInduction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy.","id":"FG000","title":"ZD1839 500mg by Mouth (po) Daily"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Duodenal Ulcer"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"59"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"57"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Induction Chemotherapy"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"69"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"66"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"}],"type":"NOT COMPLETED"}],"title":"Concurrent Chemo and Radiation Treatment"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"}],"type":"Elevated liver transaminases"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Rush"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Diarrhea"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Xerostomia"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Nausea"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Comorbid Illness"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Disease Recurrence"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"60"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"48"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"12"}],"type":"NOT COMPLETED"}],"title":"Maintenance"}],"preAssignmentDetails":"1 patient withdrew before initiating therapy and was not included in the trial. 10 patients underwent surgery to remove all gross disease before initiating study and were unevaluable for response.","recruitmentDetails":"From February 2003 to October 2004, 70 patients signed consent at three participating institutions."}