Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 11:44 AM
Study NCT ID:
NCT00025259
Status:
COMPLETED
Last Update Posted:
2017-04-12
First Post:
2001-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001761', 'term': 'Bleomycin'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C044245', 'term': '1,2-diaminocyclohexaneplatinum II citrate'}, {'id': 'D010984', 'term': 'Platinum'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'C059464', 'term': 'auricularum'}, {'id': 'C018038', 'term': 'dexamethasone acetate'}, {'id': 'C004180', 'term': 'dexamethasone 21-phosphate'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'C407664', 'term': 'deltacortene'}, {'id': 'C036266', 'term': 'prednylidene'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'resultsreportingcoordinator@childrensoncologygroup.org', 'phone': '626-447-0064', 'title': 'Results Reporting Coordinator', 'organization': "Children's Oncology Group"}, 'certainAgreement': {'otherDetails': 'Must obtain prior approval.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Serious AE:\n\nEligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).\n\nOther AE:\n\nEligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Patients Off-therapy Before Callback-Induction Only)', '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', 'otherNumAtRisk': 38, 'otherNumAffected': 23, 'seriousNumAtRisk': 38, 'seriousNumAffected': 1}, {'id': 'EG001', '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 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', 'otherNumAtRisk': 380, 'otherNumAffected': 341, 'seriousNumAtRisk': 380, 'seriousNumAffected': 2}, {'id': 'EG002', '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 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', 'otherNumAtRisk': 382, 'otherNumAffected': 334, 'seriousNumAtRisk': 382, 'seriousNumAffected': 1}, {'id': 'EG003', '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 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', 'otherNumAtRisk': 571, 'otherNumAffected': 497, 'seriousNumAtRisk': 571, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Arm V (RER With PD)', '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', 'otherNumAtRisk': 36, 'otherNumAffected': 26, 'seriousNumAtRisk': 36, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Arm VI (SER [DECA, ABVE-PC, IFRT])', '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', 'otherNumAtRisk': 153, 'otherNumAffected': 135, 'seriousNumAtRisk': 153, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Arm VII (SER [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', 'otherNumAtRisk': 152, 'otherNumAffected': 133, 'seriousNumAtRisk': 152, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 196, 'numAffected': 196}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 162, 'numAffected': 162}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 245, 'numAffected': 245}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 85, 'numAffected': 85}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 63, 'numAffected': 63}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Blood and lymphatic system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 50, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 57, 'numAffected': 57}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 111, 'numAffected': 111}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 99, 'numAffected': 99}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 128, 'numAffected': 128}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 45, 'numAffected': 45}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 31, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Cardiac disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Left ventricular systolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Endocrine disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Eye disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 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1}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Anaphylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}, {'term': 'Blood antidiuretic hormone abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 380, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 382, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 571, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Event-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '571', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '153', 'groupId': 'OG005'}, {'value': '152', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Patients Off-therapy Before Callback-Induction Only)', 'description': 'All patients-off therapy before callback-Induction only'}, {'id': 'OG001', 'title': 'Arm II (RER With CR [ABVE-PC, IFRT])', 'description': 'RER with Complete Response - IFRT (Standard Arm)'}, {'id': 'OG002', 'title': 'Arm III (RER With CR [ABVE-PC])', 'description': 'RER with Complete Response - no IFRT (Reduced Therapy Arm)'}, {'id': 'OG003', 'title': 'Arm IV (RER With Less Than CR [ABVE-PC, IFRT])', 'description': 'RER with less than Complete Response - IFRT'}, {'id': 'OG004', 'title': 'Arm V (RER With PD)', 'description': 'RER with Progressive Disease - Off Therapy'}, {'id': 'OG005', 'title': 'Arm VI (SER [DECA, ABVE-PC, IFRT])', 'description': 'SER - randomized to DECAX2 + ABVE-PCX2 + IFRT'}, {'id': 'OG006', 'title': 'Arm VII (SER [ABVE-PC, IFRT])', 'description': 'SER - randomized to ABVE-PCX2 + IFRT'}], 'classes': [{'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '0.96'}, {'value': '0.87', 'groupId': 'OG001', 'lowerLimit': '0.83', 'upperLimit': '0.90'}, {'value': '0.84', 'groupId': 'OG002', 'lowerLimit': '0.80', 'upperLimit': '0.87'}, {'value': '0.87', 'groupId': 'OG003', 'lowerLimit': '0.83', 'upperLimit': '0.89'}, {'value': '0.70', 'groupId': 'OG004', 'lowerLimit': '0.51', 'upperLimit': '0.82'}, {'value': '0.79', 'groupId': 'OG005', 'lowerLimit': '0.71', 'upperLimit': '0.85'}, {'value': '0.74', 'groupId': 'OG006', 'lowerLimit': '0.66', 'upperLimit': '0.80'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact.', 'unitOfMeasure': 'Probability of survival', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).'}, {'type': 'SECONDARY', 'title': 'Disease Response Assessed by Modified RECIST Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '571', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '153', 'groupId': 'OG005'}, {'value': '152', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Patients Off-therapy Before Callback-Induction Only)', 'description': 'All patients-off therapy before callback-Induction only'}, {'id': 'OG001', 'title': 'Arm II (RER With CR [ABVE-PC, IFRT])', 'description': 'RER with Complete Response - IFRT (Standard Arm)'}, {'id': 'OG002', 'title': 'Arm III (RER With CR [ABVE-PC])', 'description': 'RER with Complete Response - no IFRT ( Reduced Therapy Arm)'}, {'id': 'OG003', 'title': 'Arm IV (RER With Less Than CR [ABVE-PC, IFRT])', 'description': 'RER with less than Complete Response - IFRT'}, {'id': 'OG004', 'title': 'Arm V (RER With PD)', 'description': 'RER with Progressive Disease - Off Therapy'}, {'id': 'OG005', 'title': 'Arm VI (SER [DECA, ABVE-PC, IFRT])', 'description': 'SER - randomized to DECAX2 + ABVE-PCX2 + IFRT'}, {'id': 'OG006', 'title': 'Arm VII (SER [ABVE-PC, IFRT])', 'description': 'SER - randomized to ABVE-PCX2 + IFRT'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '380', 'groupId': 'OG002'}, {'value': '538', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}, {'value': '100', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.', 'description': 'Number of participants with complete response and very good partial response at the end of protocol therapy.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).'}, {'type': 'SECONDARY', 'title': 'Grade 3 or 4 Non-hematologic Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '571', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '153', 'groupId': 'OG005'}, {'value': '152', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Patients Off-therapy Before Callback-Induction Only)', 'description': 'All patients-off therapy before callback-Induction only'}, {'id': 'OG001', 'title': 'Arm II (RER With CR [ABVE-PC, IFRT])', 'description': 'RER with Complete Response - IFRT (Standard Arm)'}, {'id': 'OG002', 'title': 'Arm III (RER With CR [ABVE-PC])', 'description': 'RER with Complete Response - no IFRT ( Reduced Therapy Arm)'}, {'id': 'OG003', 'title': 'Arm IV (RER With Less Than CR [ABVE-PC, IFRT])', 'description': 'RER with less than Complete Response - IFRT'}, {'id': 'OG004', 'title': 'Arm V (RER With PD)', 'description': 'RER with Progressive Disease - Off Therapy'}, {'id': 'OG005', 'title': 'Arm VI (SER [DECA, ABVE-PC, IFRT])', 'description': 'SER - randomized to DECAX2 + ABVE-PCX2 + IFRT'}, {'id': 'OG006', 'title': 'Arm VII (SER [ABVE-PC, IFRT])', 'description': 'SER - randomized to ABVE-PCX2 + IFRT'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '216', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '62', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.', 'description': "Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated.", 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '382', 'groupId': 'OG002'}, {'value': '571', 'groupId': 'OG003'}, {'value': '153', 'groupId': 'OG004'}, {'value': '152', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Patients Off-therapy Before Callback-Induction Only)', 'description': 'All patients-off therapy before callback-Induction only'}, {'id': 'OG001', 'title': 'Arm II (RER With CR [ABVE-PC, IFRT])', 'description': 'RER with Complete Response - IFRT (Standard Arm)'}, {'id': 'OG002', 'title': 'Arm III (RER With CR [ABVE-PC])', 'description': 'RER with Complete Response - no IFRT ( Reduced Therapy Arm)'}, {'id': 'OG003', 'title': 'Arm IV (RER With Less Than CR [ABVE-PC, IFRT])', 'description': 'RER with less than Complete Response - IFRT'}, {'id': 'OG004', 'title': 'Arm VI (SER [DECA, ABVE-PC, IFRT])', 'description': 'SER - randomized to DECAX2 + ABVE-PCX2 + IFRT'}, {'id': 'OG005', 'title': 'Arm VII (SER [ABVE-PC, IFRT])', 'description': 'SER - randomized to ABVE-PCX2 + IFRT'}], 'classes': [{'categories': [{'measurements': [{'value': '0.93', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '0.98'}, {'value': '0.98', 'groupId': 'OG001', 'lowerLimit': '0.96', 'upperLimit': '0.99'}, {'value': '0.98', 'groupId': 'OG002', 'lowerLimit': '0.96', 'upperLimit': '0.99'}, {'value': '0.98', 'groupId': 'OG003', 'lowerLimit': '0.96', 'upperLimit': '0.99'}, {'value': '0.96', 'groupId': 'OG004', 'lowerLimit': '0.91', 'upperLimit': '0.98'}, {'value': '0.93', 'groupId': 'OG005', 'lowerLimit': '0.87', 'upperLimit': '0.96'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact.', 'unitOfMeasure': 'Probability of survival', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Arm V (RER with PD), has been excluded as there were no deaths observed by the Time Frame of 5 years. Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).'}]}, 'participantFlowModule': {'groups': [{'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 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': '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 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': '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 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': '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 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': 'FG004', 'title': 'Arm V (RER With PD)', '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': 'FG005', 'title': 'Arm VI (SER [DECA, ABVE-PC, IFRT])', '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': 'FG006', 'title': 'Arm VII (SER [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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', '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': 'COMPLETED', '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': 'NOT 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'}]}], 'dropWithdraws': [{'type': 'Death', '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': 'Lack of Efficacy', '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': 'Lost to Follow-up', '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': 'Physician Decision', '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': 'Protocol Violation', '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': 'Withdrawal by Subject', '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': 'Ineligible', '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': 'Randomization error', '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': 'Adverse Event', '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'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '381', 'groupId': 'BG001'}, {'value': '382', 'groupId': 'BG002'}, {'value': '571', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '153', 'groupId': 'BG005'}, {'value': '153', 'groupId': 'BG006'}, {'value': '1734', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Patients Off-therapy Before Callback-Induction Only)', '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': 'BG001', '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 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': 'BG002', '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 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': 'BG003', '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 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': 'BG004', 'title': 'Arm V (RER With PD)', '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': 'BG005', 'title': 'Arm VI (SER [DECA, ABVE-PC, IFRT])', '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': 'BG006', 'title': 'Arm VII (SER [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': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '363', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}, {'value': '143', 'groupId': 'BG005'}, {'value': '148', 'groupId': 'BG006'}, {'value': '1649', 'groupId': 'BG007'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '85', 'groupId': 'BG007'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '20'}, {'value': '14', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '21'}, {'value': '14', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '21'}, {'value': '15', 'groupId': 'BG003', 'lowerLimit': '1', 'upperLimit': '21'}, {'value': '15', 'groupId': 'BG004', 'lowerLimit': '5', 'upperLimit': '19'}, {'value': '15', 'groupId': 'BG005', 'lowerLimit': '5', 'upperLimit': '21'}, {'value': '15', 'groupId': 'BG006', 'lowerLimit': '5', 'upperLimit': '21'}, {'value': '15', 'groupId': 'BG007', 'lowerLimit': '1', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '288', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '81', 'groupId': 'BG005'}, {'value': '77', 'groupId': 'BG006'}, {'value': '815', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}, {'value': '283', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '72', 'groupId': 'BG005'}, {'value': '76', 'groupId': 'BG006'}, {'value': '919', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '259', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '293', 'groupId': 'BG001'}, {'value': '306', 'groupId': 'BG002'}, {'value': '487', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '127', 'groupId': 'BG005'}, {'value': '134', 'groupId': 'BG006'}, {'value': '1425', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '50', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '50', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '194', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '290', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}, {'value': '444', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '122', 'groupId': 'BG005'}, {'value': '124', 'groupId': 'BG006'}, {'value': '1348', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '132', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'New Zealand', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '175', 'groupId': 'BG007'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '333', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}, {'value': '491', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '125', 'groupId': 'BG005'}, {'value': '128', 'groupId': 'BG006'}, {'value': '1469', 'groupId': 'BG007'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '40', 'groupId': 'BG007'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}, {'title': 'Kuwait', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '22', 'groupId': 'BG007'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}]}]}, {'title': 'Bermuda', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}, {'title': 'French Polynesia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1734}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'lastUpdateSubmitDate': '2017-03-15', 'studyFirstSubmitDate': '2001-10-11', 'resultsFirstSubmitDate': '2016-10-19', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-13', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free Survival', 'timeFrame': '5 years', 'description': 'Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact.'}], 'secondaryOutcomes': [{'measure': 'Disease Response Assessed by Modified RECIST Criteria', 'timeFrame': 'Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.', 'description': 'Number of participants with complete response and very good partial response at the end of protocol therapy.'}, {'measure': 'Grade 3 or 4 Non-hematologic Toxicity', 'timeFrame': 'Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.', 'description': "Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated."}, {'measure': 'Overall Survival', 'timeFrame': '5 years', 'description': 'Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact.'}]}, 'conditionsModule': {'conditions': ['Childhood Lymphocyte-Depleted Classical Hodgkin Lymphoma', 'Childhood Mixed Cellularity Classical Hodgkin Lymphoma', 'Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma', 'Childhood Nodular Sclerosis Classical Hodgkin Lymphoma', 'Stage I Childhood Hodgkin Lymphoma', 'Stage II Childhood Hodgkin Lymphoma', 'Stage III Childhood Hodgkin Lymphoma', 'Stage IV Childhood Hodgkin Lymphoma']}, 'referencesModule': {'references': [{'pmid': '40135712', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.'}, {'pmid': '37505794', 'type': 'DERIVED', 'citation': "Castellino SM, Giulino-Roth L, Harker-Murray P, Kahn JM, Forlenza C, Cho S, Hoppe B, Parsons SK, Kelly KM; COG Hodgkin Lymphoma Committee. Children's Oncology Group's 2023 blueprint for research: Hodgkin lymphoma. Pediatr Blood Cancer. 2023 Sep;70 Suppl 6(Suppl 6):e30580. doi: 10.1002/pbc.30580. Epub 2023 Jul 28."}, {'pmid': '34662378', 'type': 'DERIVED', 'citation': 'Johnston RL, Mottok A, Chan FC, Jiang A, Diepstra A, Visser L, Telenius A, Gascoyne RD, Friedman DL, Schwartz CL, Kelly KM, Scott DW, Horton TM, Steidl C. A gene expression-based model predicts outcome in children with intermediate-risk classical Hodgkin lymphoma. Blood. 2022 Feb 10;139(6):889-893. doi: 10.1182/blood.2021011941.'}, {'pmid': '33512412', 'type': 'DERIVED', 'citation': "Giulino-Roth L, Pei Q, Buxton A, Bush R, Wu Y, Wolden SL, Constine LS, Kelly KM, Schwartz CL, Friedman DL. Subsequent malignant neoplasms among children with Hodgkin lymphoma: a report from the Children's Oncology Group. Blood. 2021 Mar 18;137(11):1449-1456. doi: 10.1182/blood.2020007225."}, {'pmid': '29296710', 'type': 'DERIVED', 'citation': 'Welch JJG, Schwartz CL, Higman M, Chen L, Buxton A, Kanakry JA, Kahwash SB, Hutchison RE, Friedman DL, Ambinder RF. Epstein-Barr virus DNA in serum as an early prognostic marker in children and adolescents with Hodgkin lymphoma. Blood Adv. 2017 Apr 24;1(11):681-684. doi: 10.1182/bloodadvances.2016002618. eCollection 2017 Apr 25.'}, {'pmid': '25311218', 'type': 'DERIVED', 'citation': "Friedman DL, Chen L, Wolden S, Buxton A, McCarten K, FitzGerald TJ, Kessel S, De Alarcon PA, Chen AR, Kobrinsky N, Ehrlich P, Hutchison RE, Constine LS, Schwartz CL. Dose-intensive response-based chemotherapy and radiation therapy for children and adolescents with newly diagnosed intermediate-risk hodgkin lymphoma: a report from the Children's Oncology Group Study AHOD0031. J Clin Oncol. 2014 Nov 10;32(32):3651-8. doi: 10.1200/JCO.2013.52.5410. Epub 2014 Oct 13."}]}, 'descriptionModule': {'briefSummary': "This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.", 'detailedDescription': 'OBJECTIVES:\n\nI. To compare response-based therapy to standard therapy for intermediate risk Hodgkin disease.\n\nII. To determine whether involved field radiation therapy (IFRT) can be eliminated based upon early and complete response to multiagent chemotherapy.\n\nIII. To determine whether the addition of an additional two cycles of chemotherapy (DECA) can improve outcome in those with a slow early response to standard chemotherapy.\n\nIV. To prospectively collect information on the individual prognostic significance of the following presenting factors: erythrocyte sedimentation rate, circulating levels of IL-10, each of the "B" symptoms - fever, night sweats, weight loss, nodal aggregate \\> 6 cm, large mediastinal mass \\> 1/3 thoracic diameter and number of involved nodal sites, histology, albumin, blood counts, sex and age.\n\nV. To study the reliability and utility of \\[18F\\] -Fluorodeoxyglucose (FDG) Imaging (PET scans) as an imaging modality in Hodgkin disease.\n\nVI. To determine the frequency and severity of late effects of therapy including thyroid dysfunction, infertility, cardiotoxicity, pulmonary toxicity and second malignant neoplasms.\n\nVII. To serve as the therapeutic companion to biology studies in Hodgkin disease and correlate those results with response to therapy, event free-survival and overall survival.\n\nOUTLINE: This is a randomized, multicenter study.\n\nARM I (ALL PATIENTS-OFF THERAPY BEFORE CALLBACK-INDUCTION CHEMOTHERAPY \\[ABVE-PC\\]): Patients receive doxorubicin intravenously (IV) over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or subcutaneously (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. At the end of initial chemotherapy, patients undergo evaluation for response. Patients with less than 60% disease reduction are considered to have slow early response (SER). Patients with 60% or more disease reduction are considered to have rapid early response (RER).\n\nRER: Patients receive 2 additional courses of ABVE-PC chemotherapy. After completion of treatment, patients are randomized to 1 of 4 treatment arms.\n\nARM II: Patients with sustained complete response (CR) undergo involved field radiation therapy (IFRT) approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.\n\nARM III: Patients with sustained CR receive no further treatment.\n\nARM IV: Patients with very good partial response (VGPR), partial response (PR) or stable disease (SD) undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.\n\nARM V: Patients with progressive disease are taken off therapy and treated their physician\'s discretion.\n\nSER: Patients are randomized to 1 of 2 treatment arms.\n\nARM VI: Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, cytarabine IV over 3 hours on days 1-2, and receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 and 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 and G-CSF SC beginning on day 3 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After these 2 courses, patients then receive 2 additional courses of ABVE-PC chemotherapy.\n\nARM VII: Patients receive 2 courses of ABVE-PC chemotherapy.\n\nIn both SER arms, patients with sustained CR or PR undergo IFRT approximately 3 weeks after the last course of chemotherapy.\n\nPatients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly diagnosed, pathologically confirmed Hodgkin disease (all histologies) are eligible for this protocol if they meet the following clinical stage guidelines:\n\n * All Stage IB regardless of bulk disease\n * All Stage IIB regardless of bulk disease\n * Stage IA only with bulk disease\n * Stage IIA only with bulk disease\n * All Stage IAE, IIAE regardless of bulk disease\n * All Stage IIIA, IIIAE, IIIAS, IIIAE+S regardless of bulk disease\n * All Stage IVA, IVAE regardless of bulk disease\n* May not be staged by laparotomy alone\n\n * Surgically staged patients must also have presurgical staging\n* Bilirubin no greater than 1.5 times normal\n* SGOT or SGPT less than 2.5 times normal\n* Creatinine no greater than 1.5 times normal\n* Creatinine clearance greater than 40 mL/min\n* Radioisotope glomerular filtration rate greater than 70 mL/min\n* Shortening fraction at least 27% by echocardiogram\n* Ejection fraction at least 50% by MUGA\n* No pathologic prolongation of QTc interval on 12-lead electrocardiogram\n* FEV\\_1/FVC greater than 60% by pulmonary function test\n* Pulse oximetry greater than 94%\n* No evidence of dyspnea at rest\n* No exercise intolerance\n* Adequate venous access\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No prior chemotherapy\n* At least 1 month since prior corticosteroids except prednisone for respiratory distress\n* No prior radiotherapy'}, 'identificationModule': {'nctId': 'NCT00025259', 'briefTitle': "Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease", 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease', 'orgStudyIdInfo': {'id': 'AHOD0031'}, 'secondaryIdInfos': [{'id': 'NCI-2011-02069', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000068943'}, {'id': 'COG-AHOD0031'}, {'id': 'AHOD0031', 'type': 'OTHER', 'domain': 'Childrens Oncology Group'}, {'id': 'AHOD0031', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (Patients off-therapy before callback-Induction only)', '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.', 'interventionNames': ['Biological: Bleomycin Sulfate', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin Hydrochloride', 'Drug: Etoposide', 'Biological: Filgrastim', 'Drug: Prednisone', 'Drug: Vincristine Sulfate Liposome']}, {'type': 'EXPERIMENTAL', 'label': '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 undergo IFRT approximately 3 weeks after the last day of ABVE course 4.', 'interventionNames': ['Biological: Bleomycin Sulfate', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin Hydrochloride', 'Drug: Etoposide', 'Biological: Filgrastim', 'Radiation: Involved-Field Radiation Therapy', 'Drug: Prednisone', 'Drug: Vincristine Sulfate Liposome']}, {'type': 'EXPERIMENTAL', 'label': '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 sustained CR are randomized to receive no further treatment.', 'interventionNames': ['Biological: Bleomycin Sulfate', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin Hydrochloride', 'Drug: Etoposide', 'Biological: Filgrastim', 'Drug: Prednisone', 'Drug: Vincristine Sulfate Liposome']}, {'type': 'EXPERIMENTAL', 'label': '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 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.', 'interventionNames': ['Biological: Bleomycin Sulfate', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin Hydrochloride', 'Drug: Etoposide', 'Biological: Filgrastim', 'Radiation: Involved-Field Radiation Therapy', 'Drug: Prednisone', 'Drug: Vincristine Sulfate Liposome']}, {'type': 'EXPERIMENTAL', 'label': 'Arm V (RER with PD)', '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.', 'interventionNames': ['Biological: Bleomycin Sulfate', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin Hydrochloride', 'Drug: Etoposide', 'Biological: Filgrastim', 'Drug: Prednisone', 'Drug: Vincristine Sulfate Liposome']}, {'type': 'EXPERIMENTAL', 'label': 'Arm VI (SER [DECA, ABVE-PC, IFRT])', 'description': 'Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, and cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 and 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 and G-CSF SC beginning on day 3 and 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.', 'interventionNames': ['Biological: Bleomycin Sulfate', 'Drug: Cisplatin', 'Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Dexamethasone', 'Drug: Doxorubicin Hydrochloride', 'Drug: Etoposide', 'Biological: Filgrastim', 'Radiation: Involved-Field Radiation Therapy', 'Drug: Prednisone', 'Drug: Vincristine Sulfate Liposome']}, {'type': 'EXPERIMENTAL', 'label': 'Arm VII (SER [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.', 'interventionNames': ['Biological: Bleomycin Sulfate', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin Hydrochloride', 'Drug: Etoposide', 'Biological: Filgrastim', 'Radiation: Involved-Field Radiation Therapy', 'Drug: Prednisone', 'Drug: Vincristine Sulfate Liposome']}], 'interventions': [{'name': 'Bleomycin Sulfate', 'type': 'BIOLOGICAL', 'otherNames': ['Blanoxan', 'BleMomycine', 'Blenoxane', 'Bleo-cell', 'Bleo-S', 'Bleocin', 'Bleolem', 'Bleomycin Sulfas', 'Bleomycin Sulphate', 'Blexane', 'Oil Bleo'], 'description': 'Given IV or SC', 'armGroupLabels': ['Arm I (Patients off-therapy before callback-Induction only)', 'Arm II (RER with CR [ABVE-PC, IFRT])', 'Arm III (RER with CR [ABVE-PC])', 'Arm IV (RER with less than CR [ABVE-PC, IFRT])', 'Arm V (RER with PD)', 'Arm VI (SER [DECA, ABVE-PC, IFRT])', 'Arm VII (SER [ABVE-PC, IFRT])']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['Abiplatin', 'Blastolem', 'Briplatin', 'CDDP', 'Cis-diammine-dichloroplatinum', 'Cis-diamminedichloridoplatinum', 'Cis-diamminedichloro Platinum (II)', 'Cis-diamminedichloroplatinum', 'Cis-dichloroammine Platinum (II)', 'Cis-platinous Diamine Dichloride', 'Cis-platinum', 'Cis-platinum II', 'Cis-platinum II Diamine Dichloride', 'Cismaplat', 'Cisplatina', 'Cisplatinum', 'Cisplatyl', 'Citoplatino', 'Citosin', 'Cysplatyna', 'DDP', 'Lederplatin', 'Metaplatin', 'Neoplatin', "Peyrone's Chloride", "Peyrone's Salt", 'Placis', 'Plastistil', 'Platamine', 'Platiblastin', 'Platiblastin-S', 'Platinex', 'Platinol', 'Platinol- AQ', 'Platinol-AQ', 'Platinol-AQ VHA Plus', 'Platinoxan', 'Platinum', 'Platinum Diamminodichloride', 'Platiran', 'Platistin', 'Platosin'], 'description': 'Given IV', 'armGroupLabels': ['Arm VI (SER [DECA, ABVE-PC, IFRT])']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['(-)-Cyclophosphamide', '2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate', 'Carloxan', 'Ciclofosfamida', 'Ciclofosfamide', 'Cicloxal', 'Clafen', 'Claphene', 'CP monohydrate', 'CTX', 'CYCLO-cell', 'Cycloblastin', 'Cycloblastine', 'Cyclophospham', 'Cyclophosphamid monohydrate', 'Cyclophosphamidum', 'Cyclophosphan', 'Cyclophosphane', 'Cyclophosphanum', 'Cyclostin', 'Cyclostine', 'Cytophosphan', 'Cytophosphane', 'Cytoxan', 'Fosfaseron', 'Genoxal', 'Genuxal', 'Ledoxina', 'Mitoxan', 'Neosar', 'Revimmune', 'Syklofosfamid', 'WR- 138719'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (Patients off-therapy before callback-Induction only)', 'Arm II (RER with CR [ABVE-PC, IFRT])', 'Arm III (RER with CR [ABVE-PC])', 'Arm IV (RER with less than CR [ABVE-PC, IFRT])', 'Arm V (RER with PD)', 'Arm VI (SER [DECA, ABVE-PC, IFRT])', 'Arm VII (SER [ABVE-PC, IFRT])']}, {'name': 'Cytarabine', 'type': 'DRUG', 'otherNames': ['.beta.-Cytosine arabinoside', '1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone', '1-.beta.-D-Arabinofuranosylcytosine', '1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone', '1-Beta-D-arabinofuranosylcytosine', '1.beta.-D-Arabinofuranosylcytosine', '2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-', '2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-', 'Alexan', 'Ara-C', 'ARA-cell', 'Arabine', 'Arabinofuranosylcytosine', 'Arabinosylcytosine', 'Aracytidine', 'Aracytin', 'Aracytine', 'Beta-Cytosine Arabinoside', 'CHX-3311', 'Cytarabinum', 'Cytarbel', 'Cytosar', 'Cytosar-U', 'Cytosine Arabinoside', 'Cytosine-.beta.-arabinoside', 'Cytosine-beta-arabinoside', 'Erpalfa', 'Starasid', 'Tarabine PFS', 'U 19920', 'U-19920', 'Udicil', 'WR-28453'], 'description': 'Given IV', 'armGroupLabels': ['Arm VI (SER [DECA, ABVE-PC, IFRT])']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Aacidexam', 'Adexone', 'Aknichthol Dexa', 'Alba-Dex', 'Alin', 'Alin Depot', 'Alin Oftalmico', 'Amplidermis', 'Anemul mono', 'Auricularum', 'Auxiloson', 'Baycuten', 'Baycuten N', 'Cortidexason', 'Cortisumman', 'Decacort', 'Decadrol', 'Decadron', 'Decalix', 'Decameth', 'Decasone R.p.', 'Dectancyl', 'Dekacort', 'Deltafluorene', 'Deronil', 'Desamethasone', 'Desameton', 'Dexa-Mamallet', 'Dexa-Rhinosan', 'Dexa-Scheroson', 'Dexa-sine', 'Dexacortal', 'Dexacortin', 'Dexafarma', 'Dexafluorene', 'Dexalocal', 'Dexamecortin', 'Dexameth', 'Dexamethasonum', 'Dexamonozon', 'Dexapos', 'Dexinoral', 'Dexone', 'Dinormon', 'Fluorodelta', 'Fortecortin', 'Gammacorten', 'Hexadecadrol', 'Hexadrol', 'Lokalison-F', 'Loverine', 'Methylfluorprednisolone', 'Millicorten', 'Mymethasone', 'Orgadrone', 'Spersadex', 'Visumetazone'], 'description': 'Given IV', 'armGroupLabels': ['Arm VI (SER [DECA, ABVE-PC, IFRT])']}, {'name': 'Doxorubicin Hydrochloride', 'type': 'DRUG', 'otherNames': ['5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)', 'ADM', 'Adriacin', 'Adriamycin', 'Adriamycin Hydrochloride', 'Adriamycin PFS', 'Adriamycin RDF', 'ADRIAMYCIN, HYDROCHLORIDE', 'Adriamycine', 'Adriblastina', 'Adriblastine', 'Adrimedac', 'Chloridrato de Doxorrubicina', 'DOX', 'DOXO-CELL', 'Doxolem', 'Doxorubicin.HCl', 'Doxorubin', 'Farmiblastina', 'FI 106', 'FI-106', 'hydroxydaunorubicin', 'Rubex'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (Patients off-therapy before callback-Induction only)', 'Arm II (RER with CR [ABVE-PC, IFRT])', 'Arm III (RER with CR [ABVE-PC])', 'Arm IV (RER with less than CR [ABVE-PC, IFRT])', 'Arm V (RER with PD)', 'Arm VI (SER [DECA, ABVE-PC, IFRT])', 'Arm VII (SER [ABVE-PC, IFRT])']}, {'name': 'Etoposide', 'type': 'DRUG', 'otherNames': ['Demethyl Epipodophyllotoxin Ethylidine Glucoside', 'EPEG', 'Lastet', 'Toposar', 'Vepesid', 'VP 16-213', 'VP-16', 'VP-16-213'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (Patients off-therapy before callback-Induction only)', 'Arm II (RER with CR [ABVE-PC, IFRT])', 'Arm III (RER with CR [ABVE-PC])', 'Arm IV (RER with less than CR [ABVE-PC, IFRT])', 'Arm V (RER with PD)', 'Arm VI (SER [DECA, ABVE-PC, IFRT])', 'Arm VII (SER [ABVE-PC, IFRT])']}, {'name': 'Filgrastim', 'type': 'BIOLOGICAL', 'otherNames': ['Filgrastim XM02', 'G-CSF', 'Neupogen', 'r-metHuG-CSF', 'Recombinant Methionyl Human Granulocyte Colony Stimulating Factor', 'rG-CSF', 'Tbo-filgrastim', 'Tevagrastim'], 'description': 'Given SC', 'armGroupLabels': ['Arm I (Patients off-therapy before callback-Induction only)', 'Arm II (RER with CR [ABVE-PC, IFRT])', 'Arm III (RER with CR [ABVE-PC])', 'Arm IV (RER with less than CR [ABVE-PC, IFRT])', 'Arm V (RER with PD)', 'Arm VI (SER [DECA, ABVE-PC, IFRT])', 'Arm VII (SER [ABVE-PC, IFRT])']}, {'name': 'Involved-Field Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['IFRT', 'Involved field radiotherapy'], 'description': 'Undergo IFRT', 'armGroupLabels': ['Arm II (RER with CR [ABVE-PC, IFRT])', 'Arm IV (RER with less than CR [ABVE-PC, IFRT])', 'Arm VI (SER [DECA, ABVE-PC, IFRT])', 'Arm VII (SER [ABVE-PC, IFRT])']}, {'name': 'Prednisone', 'type': 'DRUG', 'otherNames': ['.delta.1-Cortisone', '1, 2-Dehydrocortisone', 'Adasone', 'Cortancyl', 'Dacortin', 'DeCortin', 'Decortisyl', 'Decorton', 'Delta 1-Cortisone', 'Delta-Dome', 'Deltacortene', 'Deltacortisone', 'Deltadehydrocortisone', 'Deltasone', 'Deltison', 'Deltra', 'Econosone', 'Lisacort', 'Meprosona-F', 'Metacortandracin', 'Meticorten', 'Ofisolona', 'Orasone', 'Panafcort', 'Panasol-S', 'Paracort', 'PRED', 'Predicor', 'Predicorten', 'Prednicen-M', 'Prednicort', 'Prednidib', 'Prednilonga', 'Predniment', 'Prednisonum', 'Prednitone', 'Promifen', 'Servisone', 'SK-Prednisone'], 'description': 'Given orally', 'armGroupLabels': ['Arm I (Patients off-therapy before callback-Induction only)', 'Arm II (RER with CR [ABVE-PC, IFRT])', 'Arm III (RER with CR [ABVE-PC])', 'Arm IV (RER with less than CR [ABVE-PC, IFRT])', 'Arm V (RER with PD)', 'Arm VI (SER [DECA, ABVE-PC, IFRT])', 'Arm VII (SER 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