{"groups":[{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"FG000","title":"Arm I (Patients Off-therapy Before Callback-Induction Only)"},{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nInvolved-Field Radiation Therapy: Undergo IFRT\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"FG001","title":"Arm II (RER With CR [ABVE-PC, IFRT])"},{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"FG002","title":"Arm III (RER With CR [ABVE-PC])"},{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nInvolved-Field Radiation Therapy: Undergo IFRT\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"FG003","title":"Arm IV (RER With Less Than CR [ABVE-PC, IFRT])"},{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"FG004","title":"Arm V (RER With PD)"},{"description":"Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, \\& cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 \\& 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 \\& G-CSF SC beginning on day 3 \\& continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.\n\nBleomycin Sulfate: Given IV or SC\n\nCisplatin: Given IV\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV\n\nDexamethasone: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nInvolved-Field Radiation Therapy: Undergo IFRT\n\nPre","id":"FG005","title":"Arm VI (SER [DECA, ABVE-PC, IFRT])"},{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nInvolved-Field Radiation Therapy: Undergo IFRT\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"FG006","title":"Arm VII (SER [ABVE-PC, IFRT])"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"46"},{"groupId":"FG002","numSubjects":"60"},{"groupId":"FG003","numSubjects":"78"},{"groupId":"FG004","numSubjects":"11"},{"groupId":"FG005","numSubjects":"30"},{"groupId":"FG006","numSubjects":"38"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"13"},{"groupId":"FG003","numSubjects":"13"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"3"},{"groupId":"FG006","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"5"},{"groupId":"FG004","numSubjects":"4"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"3"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"27"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"14"},{"groupId":"FG004","numSubjects":"11"},{"groupId":"FG005","numSubjects":"8"},{"groupId":"FG006","numSubjects":"3"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"6"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"}],"type":"Ineligible"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"7"},{"groupId":"FG006","numSubjects":"2"}],"type":"Randomization error"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"Adverse Event"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"52"},{"groupId":"FG001","numSubjects":"381"},{"groupId":"FG002","numSubjects":"382"},{"groupId":"FG003","numSubjects":"571"},{"groupId":"FG004","numSubjects":"42"},{"groupId":"FG005","numSubjects":"153"},{"groupId":"FG006","numSubjects":"153"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"292"},{"groupId":"FG002","numSubjects":"301"},{"groupId":"FG003","numSubjects":"457"},{"groupId":"FG004","numSubjects":"6"},{"groupId":"FG005","numSubjects":"101"},{"groupId":"FG006","numSubjects":"102"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"45"},{"groupId":"FG001","numSubjects":"89"},{"groupId":"FG002","numSubjects":"81"},{"groupId":"FG003","numSubjects":"114"},{"groupId":"FG004","numSubjects":"36"},{"groupId":"FG005","numSubjects":"52"},{"groupId":"FG006","numSubjects":"51"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}]}