{"groups":[{"description":"INDUCTION THERAPY: Patients receive Induction therapy with alternating cycles of VDC and IE given every 2 weeks for 6 cycles.\n\nLOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.\n\nCONSOLIDATION THERAPY: Patients receive Consolidation therapy with alternating cycles of VDC and IE given every 2 weeks for 8 cycles.\n\nMETASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT.\n\nCyclophosphamide: Given IV\n\nDoxorubicin: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nEtoposide Phosphate: Given IV\n\nExternal Beam Radiation Therapy: Undergo EBRT\n\nIfosfamide: Given IV\n\nStereotactic Radiosurgery: Undergo SBRT\n\nTherapeutic Surgical Procedure: Undergo surgery\n\nVincristine: Given IV\n\nVincristine Sulfate: Given IV","id":"FG000","title":"Regimen A (VDC/IE)"},{"description":"INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11.\n\nLOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.\n\nCONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15.\n\nMETASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT.\n\nMAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles.\n\nCyclophosphamide: Given IV\n\nDoxorubicin: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nEtoposide Phosphate: Given IV\n\nExternal Beam Radiation Therapy: Undergo EBRT\n\nGanitumab: Given IV\n\nIfosfamide: Given IV\n\nStereotactic Radiosurgery: Undergo SBRT\n\nTherapeutic Surgical Procedure: Undergo surgery\n\nVincristine: Given IV\n\nVincristine Sulfate: Given IV","id":"FG001","title":"Regimen B (VDC/IE + Ganitumab)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"43"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"18"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"5"}],"type":"Ineligible"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"157"},{"groupId":"FG001","numSubjects":"155"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"93"},{"groupId":"FG001","numSubjects":"86"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"64"},{"groupId":"FG001","numSubjects":"69"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}]}