{"groups":[{"description":"Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP).\n\nbleomycin sulfate: At least one course administered\n\ncisplatin: At least one course administered\n\netoposide: At least one course administered","id":"FG000","title":"Arm I"},{"description":"Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.\n\nbleomycin sulfate: At least one course administered\n\ncisplatin: At least one course administered\n\netoposide: At least one course administered\n\nifosfamide: Given in a dose-dense sequential fashion\n\noxaliplatin: Given in a dose-dense sequential fashion\n\npaclitaxel: Given in a dose-dense sequential fashion","id":"FG001","title":"Arm II"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"10"}],"type":"treatment interruption"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"98"},{"groupId":"FG001","numSubjects":"105"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"91"},{"groupId":"FG001","numSubjects":"91"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"14"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Of the 263 patients registered 255 were evaluated for biomarker decrease after one cycle of BEP. Eight patients were not evaluated for biomarker decrease: 6 patients died early, 1 patient 1 withdrew consent and 1 patient was included by error. 1 patient was not covered by EC approval and excluded froma analysis. The 203 patients with unfavorable decrease in tumor biomarkers were randomized in Arm I (98 patients) or Arm II (105 patients)."}