{"groups":[{"description":"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)\n\ndactinomycin: Given IV\n\ncyclophosphamide: Given IV\n\nvincristine sulfate: Given IV\n\nradiation therapy: Undergo radiotherapy","id":"FG000","title":"Regimen I (Chemotherapy, Radiotherapy)"},{"description":"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).\n\nconventional surgery: Some patients may undergo second-look surgery\n\ndactinomycin: Given IV\n\ncyclophosphamide: Given IV\n\nvincristine sulfate: Given IV\n\nradiation therapy: Undergo radiotherapy","id":"FG001","title":"Regimen II (Chemotherapy, Radiotherapy, Surgery)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"8"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"8"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"36"},{"groupId":"FG001","numSubjects":"16"}],"type":"Ineligible for study"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"305"},{"groupId":"FG001","numSubjects":"85"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"255"},{"groupId":"FG001","numSubjects":"50"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"50"},{"groupId":"FG001","numSubjects":"35"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}]}