Viewing Study NCT00085735

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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 10:14 PM

Ignite Modification Date: 2025-12-28 @ 6:11 PM

Study NCT ID: NCT00085735

Status: COMPLETED

Last Update Posted: 2025-01-14

First Post: 2004-06-14

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008527', 'term': 'Medulloblastoma'}], 'ancestors': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C044245', 'term': '1,2-diaminocyclohexaneplatinum II citrate'}, {'id': 'D010984', 'term': 'Platinum'}, {'id': 'D061888', 'term': 'Craniospinal Irradiation'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D008130', 'term': 'Lomustine'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'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': 'D013812', 'term': 'Therapeutics'}, {'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': 'D009607', 'term': 'Nitrosourea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009603', 'term': 'Nitroso Compounds'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'resultsreporingcoordinator@childrensoncologygroup.org', 'phone': '626-447-0064', 'title': 'Results Reporting Coordinator', 'organization': "Childrens's Oncology Group"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE\'s were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (3-7 Years of Age, LDCSI, IFRT)', 'description': 'See Detailed Description (Arm I)\n\nCisplatin: Given IV\n\nCraniospinal Irradiation: Undergo craniospinal Irradiation\n\nCyclophosphamide: Given IV\n\nInvolved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLomustine: Given orally\n\nQuality-of-Life Assessment: Ancillary studies\n\nVincristine Sulfate: Given IV', 'otherNumAtRisk': 63, 'otherNumAffected': 60, 'seriousNumAtRisk': 63, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Arm II (3-7 Years of Age, LDCSI, PFRT)', 'description': 'See Detailed Description (Arm II)\n\nCisplatin: Given IV\n\nCraniospinal Irradiation: Undergo craniospinal Irradiation\n\nCyclophosphamide: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLomustine: Given orally\n\nQuality-of-Life Assessment: Ancillary studies\n\nRadiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)\n\nVincristine Sulfate: Given IV', 'otherNumAtRisk': 64, 'otherNumAffected': 61, 'seriousNumAtRisk': 64, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Arm III (3-7 Years of Age, SDCSI, IFRT)', 'description': 'See Detailed Description (Arm III)\n\nCisplatin: Given IV\n\nCraniospinal Irradiation: Undergo craniospinal Irradiation\n\nCyclophosphamide: Given IV\n\nInvolved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLomustine: Given orally\n\nQuality-of-Life Assessment: Ancillary studies\n\nVincristine Sulfate: Given IV', 'otherNumAtRisk': 60, 'otherNumAffected': 55, 'seriousNumAtRisk': 60, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Arm IV (3-7 Years of Age, SDCSI, PFRT)', 'description': 'See Detailed Description (Arm IV)\n\nCraniospinal Irradiation: Undergo craniospinal Irradiation\n\nCyclophosphamide: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLomustine: Given orally\n\nQuality-of-Life Assessment: Ancillary studies\n\nRadiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)\n\nVincristine Sulfate: Given IV', 'otherNumAtRisk': 58, 'otherNumAffected': 53, 'seriousNumAtRisk': 58, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Arm V (8-21 Years of Age, SDCSI, IFRT)', 'description': 'See Detailed Description (Arm V)\n\nCisplatin: Given IV\n\nCraniospinal Irradiation: Undergo craniospinal Irradiation\n\nCyclophosphamide: Given IV\n\nInvolved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLomustine: Given orally\n\nQuality-of-Life Assessment: Ancillary studies\n\nVincristine Sulfate: Given IV', 'otherNumAtRisk': 130, 'otherNumAffected': 123, 'seriousNumAtRisk': 130, 'seriousNumAffected': 16}, {'id': 'EG005', 'title': 'Arm VI (8-21 Years of Age, SDCSI, PFRT)', 'description': 'See Detailed Description (Arm VI)\n\nCisplatin: Given IV\n\nCraniospinal Irradiation: Undergo craniospinal Irradiation\n\nCyclophosphamide: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLomustine: Given orally\n\nQuality-of-Life Assessment: Ancillary studies\n\nRadiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)\n\nVincristine Sulfate: Given IV', 'otherNumAtRisk': 138, 'otherNumAffected': 135, 'seriousNumAtRisk': 138, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 109, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 117, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 125, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 104, 'numAffected': 27}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 278, 'numAffected': 62}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 203, 'numAffected': 55}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Blood and lymphatic system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 40, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 32, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 40, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 48, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 69, 'numAffected': 42}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 68, 'numAffected': 48}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Ear and labyrinth disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'External ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'External ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 20, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 27, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 27, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 23, 'numAffected': 11}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Middle ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders'}, {'term': 'Endocrine disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Extraocular muscle paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 10, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Eye disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Eye 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{'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypermagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Central nervous system necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cognitive disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Myelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Psychiatric disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Event-free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-dose Craniospinal Radiation (LDSCI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)'}, {'id': 'OG001', 'title': 'Standard-dose Craniospinal Radiation (SDCSI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)'}, {'id': 'OG002', 'title': 'Involved Field Radiation (IFRT)', 'description': 'Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).'}, {'id': 'OG003', 'title': 'Posterior Fossa Radiation (PFRT)', 'description': 'Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).'}], 'classes': [{'title': 'LDCSI vs SDCSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76.3', 'groupId': 'OG000', 'lowerLimit': '67.9', 'upperLimit': '84.7'}, {'value': '84.9', 'groupId': 'OG001', 'lowerLimit': '77.6', 'upperLimit': '92.2'}]}]}, {'title': 'IFRT vs PFRT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG002', 'lowerLimit': '81.1', 'upperLimit': '90.5'}, {'value': '85.8', 'groupId': 'OG003', 'lowerLimit': '81.1', 'upperLimit': '90.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '80', 'paramValue': '1.5', 'ciUpperLimit': '1.9', 'groupDescription': 'The comparison is based on all eligible randomized patients 3-7 years of age without anaplastic histology or excess residual disease or disseminated disease by central review per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed to have power of 0.80 to detect a 10% reduction in cure rate due to the use of LDCSI compared to SDCSI.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis of comparing LDCSI vs. SDCSI, a one-sided 80% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by RT group (IFRT vs. PFRT)). If the upper confidence limit is lower than 1.6, LDCSI would be deemed to be non-inferior. If not, non-inferiority would not be established.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '94', 'paramValue': '1.0', 'ciUpperLimit': '1.3', 'groupDescription': 'The comparison is based on all eligible randomized patients 3-21 years of age without anaplastic histology or excess residual disease or disseminated disease by central review as per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed with power of 0.94 to detect a 10% reduction in cure rate and power of 0.65 to detect a 5% reduction in cure rate, due to the use of IFRT compared to PFRT.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis comparing IFRT vs. PFRT, a one-sided 94% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by age group and RT group (LDCSI vs. SDCSI)). If the upper confidence limit is lower than 1.6, IFRT would be deemed to be non-inferior. If not, non-inferiority would not be established.'}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed at 3 years', 'description': "EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% confidence intervals (CI's).", 'unitOfMeasure': 'probability of 3 year EFS', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol only eligible \\& evaluable pts are included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 for this comparison. The LD/SD CSI comparison was done only in pts 3-7 yrs of age. 11/8 LD/SDCSI pts were NE, leaving 116 vs 110 for this comparison.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-dose Craniospinal Radiation (LDSCI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II)'}, {'id': 'OG001', 'title': 'Standard-dose Craniospinal Radiation (SDCSI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV)'}, {'id': 'OG002', 'title': 'Involved Field Radiation (IFRT)', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V)'}, {'id': 'OG003', 'title': 'Posterior Fossa Radiation (PFRT)', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI)'}], 'classes': [{'title': 'IFRT vs PFRT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90.3', 'groupId': 'OG002', 'lowerLimit': '86.2', 'upperLimit': '94.4'}, {'value': '93.3', 'groupId': 'OG003', 'lowerLimit': '90.0', 'upperLimit': '96.6'}]}]}, {'title': 'LDCSI vs SDCSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000', 'lowerLimit': '78.4', 'upperLimit': '92.6'}, {'value': '90.4', 'groupId': 'OG001', 'lowerLimit': '84.3', 'upperLimit': '96.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': "OS was defined as the time interval from date of study entry to date of death from any cause or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. For purposes of this analysis, arms I, III and V (involved field radiation therapy \\[IFRT\\]) are combined and compared to arms II, IV and VI (posterior fossa irradiation \\[PFRT\\]).", 'unitOfMeasure': 'Probability of 3 yr OS rate', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol only eligible \\& evaluable pts were included.Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 for this comparison. The LD/SD CSI comparison was done only in pts 3-7 yrs of age. 11/8 LD/SDCSI pts were NE, leaving 116 vs 110 for this comparison.'}, {'type': 'SECONDARY', 'title': 'Local Posterior Fossa (LPF) Failure Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Involved Field Radiation (IFRT)', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V)'}, {'id': 'OG001', 'title': 'Posterior Fossa Radiation (PFRT)', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.89'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '4.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'LPF failure was defined as tumor recurrence/progression within the tumor bed. The cumulative incidence (CI) of LPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF) and with other events prior to LPF failure (e.g., death, second malignancy) were considered as having competing events.', 'unitOfMeasure': 'percentage 3 yr cumulative incidence', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V \\[IFRT\\] are combined \\& arms II/IV/VI \\[PFRT\\] are combined. 26 \\& 23 IFRT \\& PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts.'}, {'type': 'SECONDARY', 'title': 'Non-local Posterior Fossa (NLPF) Failure Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Involved Field Radiation (IFRT)', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V)'}, {'id': 'OG001', 'title': 'Posterior Fossa Radiation (PFRT)', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '10.3'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '4.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'NLPF failure was defined as tumor recurrence/progression outside the radiation therapy clinical target volume boost (CTV-boost) but within the posterior fossa CTV (CTV-PF). The cumulative incidence (CI) of NLPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF, LPF) and with other events prior to NLPF failure (e.g., death, second malignancy) were considered as having competing events.', 'unitOfMeasure': 'Percentage of 3 yr cumulative incidence', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V \\[IFRT\\] are combined \\& arms II/IV/VI \\[PFRT\\] are combined. 26 \\& 23 IFRT \\& PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts.'}, {'type': 'SECONDARY', 'title': 'Non-posterior Fossa (NPF) Failure Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Involved Field Radiation (IFRT)', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V).'}, {'id': 'OG001', 'title': 'Posterior Fossa Radiation (PFRT)', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '8.0'}, {'value': '6.2', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '9.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'NPF failure was defined as tumor recurrence within the neuroaxis but outside the radiation therapy clinical target volume (CTV). The cumulative incidence (CI) of NPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., LPF failure) and with other events prior to NPF failure (e.g., death, second malignancy) were considered as having competing events.', 'unitOfMeasure': 'Percentage of 3 yr cumulative incidence', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V \\[IFRT\\] are combined \\& arms II/IV/VI \\[PFRT\\] are combined. 26 \\& 23 IFRT \\& PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts.'}, {'type': 'SECONDARY', 'title': 'Post-treatment Endocrine Function by CSI Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-dose Craniospinal Radiation (LDSCI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II) and with a post-treatment TSH value.'}, {'id': 'OG001', 'title': 'Standard-dose Craniospinal Radiation (SDCSI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV) and with a post-treatment TSH value.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '5.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 3 years', 'description': 'Post-treatment endocrine function was measured by laboratory assessment of the thyroid stimulating hormone (TSH). The mean TSH will be reported.', 'unitOfMeasure': 'uU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only eligible \\& evaluable pts 3-7 years of age were included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 11 and 8 LDSCI and SDCSI pts were NE, respectively, leaving 116 vs 110 for this comparison. Of these, 89 LDSCI and 79 SDCSI pts had post-treatment TSH values available and were included.'}, {'type': 'SECONDARY', 'title': 'Post-treatment Grade 3+ Hearing Loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-dose Craniospinal Radiation (LDSCI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II)'}, {'id': 'OG001', 'title': 'Standard-dose Craniospinal Radiation (SDCSI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years', 'description': 'Proportions of patients with grade 3+ hearing loss after the completion of therapy will be calculated and reported separately for low dose craniospinal irradiation (LDCSI) versus (vs.) standard dose craniospinal irradiation (SDCSI) patients. Eligible and evaluable patients 3-7 years of age will be used.', 'unitOfMeasure': 'Percentage of pts with g3+ hearing loss', 'reportingStatus': 'POSTED', 'populationDescription': 'Only eligible \\& evaluable pts 3-7 years of age are included since only younger pts were randomized to either LD or SD CSI. 11 and 8 LDCSI and SDCSI pts respectively were not evaluable due to anaplastic disease or excess residual/disseminated disease, leaving 116 vs 110 patients for this analysis.'}, {'type': 'SECONDARY', 'title': 'Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 1 (4 - 15 Months Post Diagnosis).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-dose Craniospinal Radiation (LDSCI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II) and with a post-treatment TSH value.'}, {'id': 'OG001', 'title': 'Standard-dose Craniospinal Radiation (SDCSI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV) and with a post-treatment TSH value.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.8', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '96.2', 'spread': '15.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 -15 months post diagnosis', 'description': 'Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 4-15 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only eligible \\& evaluable patients 3-7 years of age with FSIQ observations within time window were included.'}, {'type': 'SECONDARY', 'title': 'Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 2 (27 - 48 Months Post Diagnosis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-dose Craniospinal Radiation (LDSCI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II) and with a post-treatment TSH value.'}, {'id': 'OG001', 'title': 'Standard-dose Craniospinal Radiation (SDCSI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV) and with a post-treatment TSH value.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.2', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '90.5', 'spread': '13.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '27 - 48 months post diagnosis', 'description': 'Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 27-48 months post diagnosis, only the assessments before progression date were reported. The range of FSIQ is 50 - 150. A higher FSIQ is better.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only eligible \\& evaluable patients 3-7 years of age with FSIQ observations within time window were included.'}, {'type': 'SECONDARY', 'title': 'Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-dose Craniospinal Radiation (LDSCI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II) and with a post-treatment TSH value.'}, {'id': 'OG001', 'title': 'Standard-dose Craniospinal Radiation (SDCSI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV) and with a post-treatment TSH value.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.5', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '86.4', 'spread': '13.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '49 - 72 months post diagnosis', 'description': 'Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 49-72 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable patients are reported.'}, {'type': 'SECONDARY', 'title': 'Incidence of Grade 3+ Hearing Loss at 1-year Post Treatment as Assessed by CTCAE v4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Involved Field Radiation (IFRT)', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V).'}, {'id': 'OG001', 'title': 'Posterior Fossa Radiation (PFRT)', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI).'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years', 'description': 'Proportions of patients with grade 3+ hearing impairment as assessed by CTCAE v4 at 1-year post treatment were calculated.', 'unitOfMeasure': 'Percentage of pts with g3+ hearing loss', 'reportingStatus': 'POSTED', 'populationDescription': "Eligible \\& evaluable pts were included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable(NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 eligible/evaluable pts. However some pts (28/22) weren't followed for at least 1-yr post-off tx (e.g., withdrew consent for FU or died), leaving 199 IFRT/215 PFRT pts."}, {'type': 'SECONDARY', 'title': 'Incidence of Endocrine Dysfunction as Measured by Growth Hormone Stimulation Tests at the Time of Completion of Therapy by Radiotherapy (RT) Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Involved Field Radiation (IFRT)', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V)'}, {'id': 'OG001', 'title': 'Posterior Fossa Radiation (PFRT)', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '95.0'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '97.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-treatment up to 3 years', 'description': 'Endocrine dysfunction was assessed by growth hormone stimulation (GHS) tests. We report the percentage of patients with abnormal growth hormone stimulation tests.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only eligible \\& evaluable patients 3-7 years of age were included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Availability of growth hormone stimulation test results were very limited. Only 3 out of 464 eligible and evaluable patients had this data available (2 PFRT patients and 1 IFRT).'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) by Molecular Subgroup Based on Methylation Arrays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 3 Medulloblastoma', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and classified as Group 3 medulloblastoma by methylation arrays'}, {'id': 'OG001', 'title': 'Group 4 Medulloblastoma', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and classified as Group 4 medulloblastoma by methylation arrays'}, {'id': 'OG002', 'title': 'Sonic Hedgehog (SHH) Medulloblastoma', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and classified as SHH medulloblastoma by methylation arrays'}, {'id': 'OG003', 'title': 'Wingless (WNT) Medulloblastoma', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and classified as WNT medulloblastoma by methylation arrays'}], 'classes': [{'categories': [{'measurements': [{'value': '76.3', 'groupId': 'OG000', 'lowerLimit': '66.5', 'upperLimit': '86.1'}, {'value': '97.3', 'groupId': 'OG001', 'lowerLimit': '94.8', 'upperLimit': '99.8'}, {'value': '92.0', 'groupId': 'OG002', 'lowerLimit': '85.1', 'upperLimit': '98.9'}, {'value': '98.3', 'groupId': 'OG003', 'lowerLimit': '95.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': "OS was defined as the time interval from date of study entry to date of death from any cause or to date of last contact for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's.", 'unitOfMeasure': 'Percent probability of overall survival', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '355 patients were classified into one of the medulloblastoma subgroups by methylation arrays and included in this analysis; 74 were Group 3 medulloblastoma, 154 were Group 4 medulloblastoma, 64 were SHH medulloblastoma, and 63 were WNT medulloblastoma patients.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) by Molecular Subgroup Based on Methylation Arrays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 3 Medulloblastoma', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and classified as Group 3 medulloblastoma by methylation arrays'}, {'id': 'OG001', 'title': 'Group 4 Medulloblastoma', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and classified as Group 4 medulloblastoma by methylation arrays'}, {'id': 'OG002', 'title': 'Sonic Hedgehog (SHH) Medulloblastoma', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and classified as SHH medulloblastoma by methylation arrays'}, {'id': 'OG003', 'title': 'Wingless (WNT) Medulloblastoma', 'description': 'Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and classified as WNT medulloblastoma by methylation arrays'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000', 'lowerLimit': '60.0', 'upperLimit': '81.2'}, {'value': '90.6', 'groupId': 'OG001', 'lowerLimit': '85.9', 'upperLimit': '95.3'}, {'value': '90.4', 'groupId': 'OG002', 'lowerLimit': '83.1', 'upperLimit': '97.7'}, {'value': '98.4', 'groupId': 'OG003', 'lowerLimit': '95.3', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': "PFS was defined as the time interval from date of study entry to disease progression, relapse or death due to cancer or to last follow-up. Second malignancies and deaths from causes clearly not associated with tumor progression or recurrence were censored. PFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's.", 'unitOfMeasure': 'Percentage probability of PFS', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '355 patients were classified into one of the medulloblastoma subgroups by methylation arrays and included in this analysis; 74 were Group 3 medulloblastoma, 154 were Group 4 medulloblastoma, 64 were SHH medulloblastoma, and 63 were WNT medulloblastoma patients.'}, {'type': 'SECONDARY', 'title': 'Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 1 (4-15 Months Post Diagnosis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-dose Craniospinal Radiation (LDSCI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II) and with a post-treatment TSH value.'}, {'id': 'OG001', 'title': 'Standard-dose Craniospinal Radiation (SDCSI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV) and with a post-treatment TSH value.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.7', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '51.3', 'spread': '9.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 - 15 months post diagnosis', 'description': 'Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only eligible \\& evaluable patients 3-7 years of age with MI values within time window were included.'}, {'type': 'SECONDARY', 'title': 'Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 2 (27-48 Months Post Diagnosis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-dose Craniospinal Radiation (LDSCI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II) and with a post-treatment TSH value.'}, {'id': 'OG001', 'title': 'Standard-dose Craniospinal Radiation (SDCSI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV) and with a post-treatment TSH value.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.4', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '55.0', 'spread': '9.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '27-48 months post diagnosis', 'description': 'Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only eligible \\& evaluable patients 3-7 years of age with MI values within time window were included.'}, {'type': 'SECONDARY', 'title': 'Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-dose Craniospinal Radiation (LDSCI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II) and with a post-treatment TSH value.'}, {'id': 'OG001', 'title': 'Standard-dose Craniospinal Radiation (SDCSI)', 'description': 'Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV) and with a post-treatment TSH value.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.1', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '58.6', 'spread': '11.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '49 - 72 months post diagnosis', 'description': 'Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only eligible \\& evaluable patients 3-7 years of age with MI values within time window were included.'}, {'type': 'SECONDARY', 'title': 'Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 1 (4-15 Months Post Diagnosis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eligible and Evaluable Patients', 'description': 'All eligible and evaluable patients enrolled on ACNS0331'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '54', 'upperLimit': '62'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-15 months post diagnosis', 'description': 'Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 4 - 15 months post diagnosis.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible and evaluable patients enrolled. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate.'}, {'type': 'SECONDARY', 'title': 'Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 2 (27-48 Months Post Diagnosis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eligible and Evaluable Patients', 'description': 'All eligible and evaluable patients enrolled on ACNS0331'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '36'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '27-48 months post diagnosis', 'description': 'Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 27 - 48 months post diagnosis.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible and evaluable patients enrolled. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate.'}, {'type': 'SECONDARY', 'title': 'Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 3 (49 - 72 Months Post Diagnosis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eligible and Evaluable Patients', 'description': 'All eligible and evaluable patients enrolled on ACNS0331'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '61', 'upperLimit': '77'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '49 - 72 months post diagnosis', 'description': 'Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 49 - 72 months post diagnosis.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible and evaluable patients enrolled. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (3-7 Yrs of Age, LDCSI, IFRT)', 'description': 'Patients 3-7 years of age, LDCSI, IFRT'}, {'id': 'FG001', 'title': 'Arm II (3-7 Yrs of Age, LDCSI, PFRT)', 'description': 'Patients 3-7 years of age, LDCSI, PFRT'}, {'id': 'FG002', 'title': 'Arm III (3-7 Yrs of Age, SDCSI, IFRT)', 'description': 'Patients 3-7 years of age, SDCSI, IFRT'}, {'id': 'FG003', 'title': 'Arm IV (3-7 Yrs of Age, SDCSI, PFRT)', 'description': 'Patients 3-7 years of age, SDCSI, PFRT'}, {'id': 'FG004', 'title': 'Arm V (8-21 Yrs of Age, SDCSI, IFRT)', 'description': 'Patients 8-21 years of age, SDCSI, IFRT'}, {'id': 'FG005', 'title': 'Arm VI (8-21 Yrs of Age, SDCSI, PFRT)', 'description': 'Patients 8-21 yrs of age, SDCSI, PFRT'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '65'}, {'groupId': 'FG004', 'numSubjects': '147'}, {'groupId': 'FG005', 'numSubjects': '146'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '46'}, {'groupId': 'FG003', 'numSubjects': '46'}, {'groupId': 'FG004', 'numSubjects': '105'}, {'groupId': 'FG005', 'numSubjects': '115'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '42'}, {'groupId': 'FG005', 'numSubjects': '31'}]}], 'dropWithdraws': [{'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'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', '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'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'Patient ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'Excess residual disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Reason not documented', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Pt transferred to inst w/out study open', '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'}]}]}], 'recruitmentDetails': "Participants 3-21 years of age were recruited at Children's Oncology Group institutions worldwide and at sites affiliated with the Dutch Childhood Oncology Group. The first patient was enrolled on April 30, 2004 and the last patient was enrolled on January 6, 2014.", 'preAssignmentDetails': 'Patients were randomized to receive a smaller volume boost (radiation to tumor bed)(IFRT) or standard volume boost (radiation to the entire posterior fossa) (PFRT).Patients 3-7 years of age were also randomized to receive reduced-dose craniospinal radiation (LDCSI) or standard-dose craniospinal radiation (SDCSI).Patients 8 and older received SDCSI.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '130', 'groupId': 'BG004'}, {'value': '138', 'groupId': 'BG005'}, {'value': '513', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (3-7 Years of Age, LDCSI, IFRT)', 'description': 'Eligible patients 3-7 yrs of age, LDCSI, IFRT'}, {'id': 'BG001', 'title': 'Arm II (3-7 Years of Age, LDCSI, PFRT)', 'description': 'Eligible patients 3-7 yrs of age, LDCSI, PFRT'}, {'id': 'BG002', 'title': 'Arm III (3-7 Years of Age, SDCSI, IFRT)', 'description': 'Eligible patients 3-7 yrs of age, SDCSI, IFRT'}, {'id': 'BG003', 'title': 'Arm IV (3-7 Years of Age, SDCSI, PFRT)', 'description': 'Eligible patients 3-7 yrs of age, SDCSI, PFRT'}, {'id': 'BG004', 'title': 'Arm V (8-21 Years of Age, SDCSI, IFRT)', 'description': 'Eligible patients 8-21 yrs of age, SDCSI, IFRT'}, {'id': 'BG005', 'title': 'Arm VI (8-21 Years of Age, SDCSI, PFRT)', 'description': 'Eligible patients 8-21 yrs of age, SDCSI, PFRT'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}, {'value': '128', 'groupId': 'BG005'}, {'value': '493', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'BG000', 'lowerLimit': '3.2', 'upperLimit': '7.8'}, {'value': '5.9', 'groupId': 'BG001', 'lowerLimit': '3.3', 'upperLimit': '7.9'}, {'value': '5.9', 'groupId': 'BG002', 'lowerLimit': '3.0', 'upperLimit': '8.0'}, {'value': '5.4', 'groupId': 'BG003', 'lowerLimit': '3.1', 'upperLimit': '7.7'}, {'value': '12.4', 'groupId': 'BG004', 'lowerLimit': '8.0', 'upperLimit': '19.8'}, {'value': '11.8', 'groupId': 'BG005', 'lowerLimit': '8', 'upperLimit': '21.8'}, {'value': '8.3', 'groupId': 'BG006', 'lowerLimit': '3.0', 'upperLimit': '21.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '51', 'groupId': 'BG005'}, {'value': '184', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}, {'value': '87', 'groupId': 'BG005'}, {'value': '329', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '87', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}, {'value': '109', 'groupId': 'BG005'}, {'value': '410', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}]}]}], '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': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '108', 'groupId': 'BG004'}, {'value': '120', 'groupId': 'BG005'}, {'value': '420', 'groupId': 'BG006'}]}, {'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'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '35', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Only eligible patients are included in each of the 6 groups for baseline characteristics.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 549}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2004-06-14', 'resultsFirstSubmitDate': '2017-02-22', 'studyFirstSubmitQcDate': '2004-06-15', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-16', 'studyFirstPostDateStruct': {'date': '2004-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free Survival (EFS)', 'timeFrame': 'Assessed at 3 years', 'description': "EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% confidence intervals (CI's)."}, {'measure': 'Overall Survival (OS)', 'timeFrame': '3 years', 'description': "OS was defined as the time interval from date of study entry to date of death from any cause or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. For purposes of this analysis, arms I, III and V (involved field radiation therapy \\[IFRT\\]) are combined and compared to arms II, IV and VI (posterior fossa irradiation \\[PFRT\\])."}], 'secondaryOutcomes': [{'measure': 'Local Posterior Fossa (LPF) Failure Rate', 'timeFrame': '3 years', 'description': 'LPF failure was defined as tumor recurrence/progression within the tumor bed. The cumulative incidence (CI) of LPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF) and with other events prior to LPF failure (e.g., death, second malignancy) were considered as having competing events.'}, {'measure': 'Non-local Posterior Fossa (NLPF) Failure Rate', 'timeFrame': '3 years', 'description': 'NLPF failure was defined as tumor recurrence/progression outside the radiation therapy clinical target volume boost (CTV-boost) but within the posterior fossa CTV (CTV-PF). The cumulative incidence (CI) of NLPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF, LPF) and with other events prior to NLPF failure (e.g., death, second malignancy) were considered as having competing events.'}, {'measure': 'Non-posterior Fossa (NPF) Failure Rate', 'timeFrame': '3 years', 'description': 'NPF failure was defined as tumor recurrence within the neuroaxis but outside the radiation therapy clinical target volume (CTV). The cumulative incidence (CI) of NPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., LPF failure) and with other events prior to NPF failure (e.g., death, second malignancy) were considered as having competing events.'}, {'measure': 'Post-treatment Endocrine Function by CSI Group', 'timeFrame': 'Up to 3 years', 'description': 'Post-treatment endocrine function was measured by laboratory assessment of the thyroid stimulating hormone (TSH). The mean TSH will be reported.'}, {'measure': 'Post-treatment Grade 3+ Hearing Loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4', 'timeFrame': 'Up to 3 years', 'description': 'Proportions of patients with grade 3+ hearing loss after the completion of therapy will be calculated and reported separately for low dose craniospinal irradiation (LDCSI) versus (vs.) standard dose craniospinal irradiation (SDCSI) patients. Eligible and evaluable patients 3-7 years of age will be used.'}, {'measure': 'Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 1 (4 - 15 Months Post Diagnosis).', 'timeFrame': '4 -15 months post diagnosis', 'description': 'Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 4-15 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better.'}, {'measure': 'Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 2 (27 - 48 Months Post Diagnosis)', 'timeFrame': '27 - 48 months post diagnosis', 'description': 'Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 27-48 months post diagnosis, only the assessments before progression date were reported. The range of FSIQ is 50 - 150. A higher FSIQ is better.'}, {'measure': 'Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)', 'timeFrame': '49 - 72 months post diagnosis', 'description': 'Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 49-72 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better.'}, {'measure': 'Incidence of Grade 3+ Hearing Loss at 1-year Post Treatment as Assessed by CTCAE v4', 'timeFrame': 'Up to 3 years', 'description': 'Proportions of patients with grade 3+ hearing impairment as assessed by CTCAE v4 at 1-year post treatment were calculated.'}, {'measure': 'Incidence of Endocrine Dysfunction as Measured by Growth Hormone Stimulation Tests at the Time of Completion of Therapy by Radiotherapy (RT) Group', 'timeFrame': 'Post-treatment up to 3 years', 'description': 'Endocrine dysfunction was assessed by growth hormone stimulation (GHS) tests. We report the percentage of patients with abnormal growth hormone stimulation tests.'}, {'measure': 'Overall Survival (OS) by Molecular Subgroup Based on Methylation Arrays', 'timeFrame': '3 years', 'description': "OS was defined as the time interval from date of study entry to date of death from any cause or to date of last contact for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's."}, {'measure': 'Progression-free Survival (PFS) by Molecular Subgroup Based on Methylation Arrays', 'timeFrame': '3 years', 'description': "PFS was defined as the time interval from date of study entry to disease progression, relapse or death due to cancer or to last follow-up. Second malignancies and deaths from causes clearly not associated with tumor progression or recurrence were censored. PFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's."}, {'measure': 'Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 1 (4-15 Months Post Diagnosis)', 'timeFrame': '4 - 15 months post diagnosis', 'description': 'Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction.'}, {'measure': 'Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 2 (27-48 Months Post Diagnosis)', 'timeFrame': '27-48 months post diagnosis', 'description': 'Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction.'}, {'measure': 'Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)', 'timeFrame': '49 - 72 months post diagnosis', 'description': 'Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction.'}, {'measure': 'Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 1 (4-15 Months Post Diagnosis)', 'timeFrame': '4-15 months post diagnosis', 'description': 'Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 4 - 15 months post diagnosis.'}, {'measure': 'Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 2 (27-48 Months Post Diagnosis)', 'timeFrame': '27-48 months post diagnosis', 'description': 'Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 27 - 48 months post diagnosis.'}, {'measure': 'Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 3 (49 - 72 Months Post Diagnosis)', 'timeFrame': '49 - 72 months post diagnosis', 'description': 'Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 49 - 72 months post diagnosis.'}]}, 'conditionsModule': {'conditions': ['Medulloblastoma']}, 'referencesModule': {'availIpds': [{'url': 'https://nctn-data-archive.nci.nih.gov/', 'type': 'Individual Participant Data Set', 'comment': 'Data Available: Individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive'}], 'references': [{'pmid': '34110925', 'type': 'DERIVED', 'citation': "Michalski JM, Janss AJ, Vezina LG, Smith KS, Billups CA, Burger PC, Embry LM, Cullen PL, Hardy KK, Pomeroy SL, Bass JK, Perkins SM, Merchant TE, Colte PD, Fitzgerald TJ, Booth TN, Cherlow JM, Muraszko KM, Hadley J, Kumar R, Han Y, Tarbell NJ, Fouladi M, Pollack IF, Packer RJ, Li Y, Gajjar A, Northcott PA. Children's Oncology Group Phase III Trial of Reduced-Dose and Reduced-Volume Radiotherapy With Chemotherapy for Newly Diagnosed Average-Risk Medulloblastoma. J Clin Oncol. 2021 Aug 20;39(24):2685-2697. doi: 10.1200/JCO.20.02730. Epub 2021 Jun 10."}]}, 'descriptionModule': {'briefSummary': 'This randomized phase III trial is studying how well standard-dose radiation therapy works compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard volume boost radiation therapy works compared to smaller volume boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy is more effective than reduced-dose radiation therapy when given together with chemotherapy after surgery in treating young patients with medulloblastoma.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine whether reducing the craniospinal dose of radiation therapy to 18.00 Gy in children 3-7 years of age does not compromise event-free survival and overall survival as compared to treatment with 23.40 Gy of craniospinal radiation; and to determine if reducing the irradiated volume of the primary site tumor boost from the whole posterior fossa to the tumor bed only will not compromise event-free and overall survival.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate patterns of failure in children treated with an irradiation boost volume smaller than conventional posterior fossa volumes.\n\nII. To reduce the cognitive, auditory and endocrinologic effects of treatment of average-risk medulloblastoma by reducing the dose of craniospinal irradiation therapy.\n\nIII. To determine if the audiologic and endocrinologic toxicity will be reduced with the use of limited tumor boost volume irradiation compared to patients treated with conventional target volumes of radiation.\n\nIV. To develop an optimal gene expression medulloblastoma outcome predictor, validated prospectively in a multi-institution randomized clinical trial.\n\nV. To improve compliance with long-term quality of life and functional status data submission by educating institutional nurses to administer and submit for analysis a battery of four instruments: Behavior Assessment System for Children- 2nd Edition (BASC-2), Adaptive Behavior Assessment System - 2nd Edition (ABAS-II), Behavior Rating Inventory of Executive Function (BRIEF), PedsQLTM 4.0.\n\nOUTLINE: Patients 3-7 years of age are randomized to 1 of 4 arms (Arm I-IV). Patients 8-21 years of age are randomized to 1 of 2 arms (Arm V or VI).\n\nWithin 31 days after definitive surgery, all patients begin therapy. Patients undergo radiation therapy with doses according to their Arm randomization on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6). All patients receive vincristine intravenously (IV) over 1 minute (or infusion via minibag as per institutional policy) on days 8, 15, 22, 29, 36, and 43 (weeks 1-6).\n\nARM I: Patients 3-7 years of age undergo lowered dose craniospinal irradiation (LDCSI) with involved-field radiation therapy (IFRT) boost.\n\nARM II: Patients 3-7 years of age undergo LDCSI with whole posterior fossa radiation therapy (PFRT) boost.\n\nARM III: Patients 3-7 years of age undergo standard dose craniospinal irradiation (SDCSI) with IFRT boost.\n\nARM IV: Patients 3-7 years of age undergo SDCSI with PFRT boost.\n\nARM V: Patients 8-21 years of age undergo SDCSI with IFRT boost.\n\nARM VI: Patients 8-21 years of age undergo SDCSI with PFRT boost.\n\nMAINTENANCE CHEMOTHERAPY: Beginning 4 weeks after completion of chemoradiotherapy, patients receive 2 different regimens of maintenance chemotherapy for a total of 9 courses. Each course in regimen A is 6 weeks (42 days) in duration. Each course in regimen B is 4 weeks (28 days) in duration.\n\nREGIMEN A (courses 1, 2, 4, 5, 7, and 8): Patients receive lomustine orally and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1, 8, and 15 of weeks 11, 17, 27, 33, 43, and 49.\n\nREGIMEN B (courses 3, 6, and 9): Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and vincristine IV on days 1 and 8 of weeks 23, 39, and 55.\n\nTreatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at 3-6 months after completion of radiotherapy and at 3-4 years after study entry. Neurocognitive function may also be assessed.\n\nPatients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.\n\nOUTLINE: Patients 3-7 years of age are randomized to 1 of 4 arms (Arm I-IV). Patients 8-21 years of age are randomized to 1 of 2 arms (Arm V or VI).\n\nWithin 31 days after definitive surgery, all patients begin therapy. Patients undergo radiation therapy with doses according to their Arm randomization on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6). All patients receive vincristine intravenously (IV) over 1 minute (or infusion via minibag as per institutional policy) on days 8, 15, 22, 29, 36, and 43 (weeks 1-6).\n\nARM I: Patients 3-7 years of age undergo lowered dose craniospinal irradiation (LDCSI) with involved-field radiation therapy (IFRT) boost.\n\nARM II: Patients 3-7 years of age undergo LDCSI with whole posterior fossa radiation therapy (PFRT) boost.\n\nARM III: Patients 3-7 years of age undergo standard dose craniospinal irradiation (SDCSI) with IFRT boost.\n\nARM IV: Patients 3-7 years of age undergo SDCSI with PFRT boost.\n\nARM V: Patients 8-21 years of age undergo SDCSI with IFRT boost.\n\nARM VI: Patients 8-21 years of age undergo SDCSI with PFRT boost.\n\nMAINTENANCE CHEMOTHERAPY: Beginning 4 weeks after completion of chemoradiotherapy, patients receive 2 different regimens of maintenance chemotherapy for a total of 9 courses. Each course in regimen A is 6 weeks (42 days) in duration. Each course in regimen B is 4 weeks (28 days) in duration.\n\nREGIMEN A (courses 1, 2, 4, 5, 7, and 8): Patients receive lomustine orally and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1, 8, and 15 of weeks 11, 17, 27, 33, 43, and 49.\n\nREGIMEN B (courses 3, 6, and 9): Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and vincristine IV on days 1 and 8 of weeks 23, 39, and 55.\n\nTreatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at 3-6 months after completion of radiotherapy and at 3-4 years after study entry. Neurocognitive function may also be assessed.\n\nPatients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed medulloblastoma located in the posterior fossa\n\n * Standard-risk disease\n* Minimal volume, non-disseminated disease, defined by the following:\n\n * Residual tumor ≤ 1.5 cm\\^2 confirmed by MRI with contrast imaging within 21 days after surgery\n * No metastatic disease in the head, spine, or cerebrospinal fluid (CSF) confirmed by both of the following:\n\n * Enhanced MRI of the spine within 5 days before surgery OR within 28 days after surgery\n * Negative cytological examination of CSF after surgery, but before study enrollment\n* Brain stem involvement allowed\n* Performance status - Karnofsky 50-100% (\\> 16 years of age)\n* Performance status - Lansky 30-100% (≤ 16 years of age)\n* Absolute neutrophil count \\> 1,500/uL\n* Platelet count \\> 100,000/uL (transfusion independent)\n* Hemoglobin \\> 10 g/dL (transfusions allowed)\n* Bilirubin \\< 1.5 times upper limit of normal (ULN) for age\n* AST or ALT \\< 1.5 times ULN for age\n* Creatinine clearance OR radioisotope glomerular filtration rate \\>= 70 mL/min/1.73m\\^2 or a serum creatinine based on age/gender as follows:\n\nAge Maximum Serum Creatine (mg/dL)\n\n* 1month to \\< 6 months male: 0.4 female: 0.4\n* 6 months to \\<1 year male: 0.5 female: 0.5\n* 1 year to \\< 2 years male: 0.6 female: 0.6\n* 2 to \\< 6 years male: 0.8 female: 0.8\n* 6 to \\< 10 years male: 1 female: 1\n* 10 to \\< 13 years male: 1.2 female: 1.2\n* 13 to \\< 16 years male: 1.5 female: 1.4\n* \\>= 16 years male: 1.7 female: 1.4\n\n * Not pregnant or nursing\n * Negative pregnancy test\n * Fertile patients must use effective contraception\n * No prior chemotherapy\n * Prior corticosteroids allowed\n * No prior radiotherapy'}, 'identificationModule': {'nctId': 'NCT00085735', 'briefTitle': 'Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children With Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial', 'orgStudyIdInfo': {'id': 'ACNS0331'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00335', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'ACNS0331'}, {'id': '12238'}, {'id': 'COG-ACNS0331'}, {'id': 'CDR0000365506'}, {'id': 'ACNS0331', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'ACNS0331', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180886', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180886', 'type': 'NIH'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (3-7 years of age, LDCSI, IFRT)', 'description': 'See Detailed Description (Arm I)', 'interventionNames': ['Drug: Cisplatin', 'Radiation: Craniospinal Irradiation', 'Drug: Cyclophosphamide', 'Radiation: Involved-Field Radiation Therapy', 'Other: Laboratory Biomarker Analysis', 'Drug: Lomustine', 'Other: Quality-of-Life Assessment', 'Drug: Vincristine Sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (3-7 years of age, LDCSI, PFRT)', 'description': 'See Detailed Description (Arm II)', 'interventionNames': ['Drug: Cisplatin', 'Radiation: Craniospinal Irradiation', 'Drug: Cyclophosphamide', 'Other: Laboratory Biomarker Analysis', 'Drug: Lomustine', 'Other: Quality-of-Life Assessment', 'Radiation: Radiation Therapy', 'Drug: Vincristine Sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm III (3-7 years of age, SDCSI, IFRT)', 'description': 'See Detailed Description (Arm III)', 'interventionNames': ['Drug: Cisplatin', 'Radiation: Craniospinal Irradiation', 'Drug: Cyclophosphamide', 'Radiation: Involved-Field Radiation Therapy', 'Other: Laboratory Biomarker Analysis', 'Drug: Lomustine', 'Other: Quality-of-Life Assessment', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm IV (3-7 years of age, SDCSI, PFRT)', 'description': 'See Detailed Description (Arm IV)', 'interventionNames': ['Radiation: Craniospinal Irradiation', 'Drug: Cyclophosphamide', 'Other: Laboratory Biomarker Analysis', 'Drug: Lomustine', 'Other: Quality-of-Life Assessment', 'Radiation: Radiation Therapy', 'Drug: Vincristine Sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm V (8-21 years of age, SDCSI, IFRT)', 'description': 'See Detailed Description (Arm V)', 'interventionNames': ['Drug: Cisplatin', 'Radiation: Craniospinal Irradiation', 'Drug: Cyclophosphamide', 'Radiation: Involved-Field Radiation Therapy', 'Other: Laboratory Biomarker Analysis', 'Drug: Lomustine', 'Other: Quality-of-Life Assessment', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm VI (8-21 years of age, SDCSI, PFRT)', 'description': 'See Detailed Description (Arm VI)', 'interventionNames': ['Drug: Cisplatin', 'Radiation: Craniospinal Irradiation', 'Drug: Cyclophosphamide', 'Other: Laboratory Biomarker Analysis', 'Drug: Lomustine', 'Other: Quality-of-Life Assessment', 'Radiation: Radiation Therapy', 'Drug: Vincristine Sulfate']}], 'interventions': [{'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 I (3-7 years of age, LDCSI, IFRT)', 'Arm II (3-7 years of age, LDCSI, PFRT)', 'Arm III (3-7 years of age, SDCSI, IFRT)', 'Arm V (8-21 years of age, SDCSI, IFRT)', 'Arm VI (8-21 years of age, SDCSI, PFRT)']}, {'name': 'Craniospinal Irradiation', 'type': 'RADIATION', 'description': 'Undergo craniospinal Irradiation', 'armGroupLabels': ['Arm I (3-7 years of age, LDCSI, IFRT)', 'Arm II (3-7 years of age, LDCSI, PFRT)', 'Arm III (3-7 years of age, SDCSI, IFRT)', 'Arm IV (3-7 years of age, SDCSI, PFRT)', 'Arm V (8-21 years of age, SDCSI, IFRT)', 'Arm VI (8-21 years of age, SDCSI, PFRT)']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['(-)-Cyclophosphamide', '2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate', 'Asta B 518', 'B 518', 'B-518', 'B518', 'Carloxan', 'Ciclofosfamida', 'Ciclofosfamide', 'Cicloxal', 'Clafen', 'Claphene', 'CP monohydrate', 'CTX', 'CYCLO-cell', 'Cycloblastin', 'Cycloblastine', 'Cyclophospham', 'Cyclophosphamid monohydrate', 'Cyclophosphamide Monohydrate', 'Cyclophosphamidum', 'Cyclophosphan', 'Cyclophosphane', 'Cyclophosphanum', 'Cyclostin', 'Cyclostine', 'Cytophosphan', 'Cytophosphane', 'Cytoxan', 'Fosfaseron', 'Genoxal', 'Genuxal', 'Ledoxina', 'Mitoxan', 'Neosar', 'Revimmune', 'Syklofosfamid', 'WR 138719', 'WR- 138719', 'WR-138719', 'WR138719'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (3-7 years of age, LDCSI, IFRT)', 'Arm II (3-7 years of age, LDCSI, PFRT)', 'Arm III (3-7 years of age, SDCSI, IFRT)', 'Arm IV (3-7 years of age, SDCSI, PFRT)', 'Arm V (8-21 years of age, SDCSI, IFRT)', 'Arm VI (8-21 years of age, SDCSI, PFRT)']}, {'name': 'Involved-Field Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['IFRT', 'Involved field radiotherapy'], 'description': 'Undergo smaller volume boost (involved-field radiation therapy)', 'armGroupLabels': ['Arm I (3-7 years of age, LDCSI, IFRT)', 'Arm III (3-7 years of age, SDCSI, IFRT)', 'Arm V (8-21 years of age, SDCSI, IFRT)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (3-7 years of age, LDCSI, IFRT)', 'Arm II (3-7 years of age, LDCSI, PFRT)', 'Arm III (3-7 years of age, SDCSI, IFRT)', 'Arm IV (3-7 years of age, SDCSI, PFRT)', 'Arm V (8-21 years of age, SDCSI, IFRT)', 'Arm VI (8-21 years of age, SDCSI, PFRT)']}, {'name': 'Lomustine', 'type': 'DRUG', 'otherNames': ['1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea', '1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-', 'Belustin', 'Belustine', 'CCNU', 'Cecenu', 'CeeNU', 'Chloroethylcyclohexylnitrosourea', 'Citostal', 'Gleostine', 'Lomeblastin', 'Lomustinum', 'Lucostin', 'Lucostine', "N-(2-Chloroethyl)-N'-cyclohexyl-N-nitrosourea", 'Prava', 'RB-1509', 'WR-139017'], 'description': 'Given orally', 'armGroupLabels': ['Arm I (3-7 years of age, LDCSI, IFRT)', 'Arm II (3-7 years of age, LDCSI, PFRT)', 'Arm III (3-7 years of age, SDCSI, IFRT)', 'Arm IV (3-7 years of age, SDCSI, PFRT)', 'Arm V (8-21 years of age, SDCSI, IFRT)', 'Arm VI (8-21 years of age, SDCSI, PFRT)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (3-7 years of age, LDCSI, IFRT)', 'Arm II (3-7 years of age, LDCSI, PFRT)', 'Arm III (3-7 years of age, SDCSI, IFRT)', 'Arm IV (3-7 years of age, SDCSI, PFRT)', 'Arm V (8-21 years of age, SDCSI, IFRT)', 'Arm VI (8-21 years of age, SDCSI, PFRT)']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Cancer Radiotherapy', 'Energy Type', 'ENERGY_TYPE', 'Irradiate', 'Irradiated', 'Irradiation', 'Radiation', 'Radiation Therapy, NOS', 'Radiotherapeutics', 'Radiotherapy', 'RT', 'Therapy, Radiation'], 'description': 'Undergo standard volume boost (whole posterior fossa radiation therapy)', 'armGroupLabels': ['Arm II (3-7 years of age, LDCSI, PFRT)', 'Arm IV (3-7 years of age, SDCSI, PFRT)', 'Arm VI (8-21 years of age, SDCSI, PFRT)']}, {'name': 'Vincristine Sulfate', 'type': 'DRUG', 'otherNames': ['Kyocristine', 'Leurocristine Sulfate', 'Leurocristine, sulfate', 'Oncovin', 'Vincasar', 'Vincosid', 'Vincrex', 'Vincristine, sulfate'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (3-7 years of age, LDCSI, IFRT)', 'Arm II (3-7 years of age, LDCSI, PFRT)', 'Arm III (3-7 years of age, SDCSI, IFRT)', 'Arm IV (3-7 years of age, SDCSI, PFRT)', 'Arm V (8-21 years of age, SDCSI, IFRT)', 'Arm VI (8-21 years of age, SDCSI, PFRT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Childrens Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Downey Medical Center', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Miller Children's and Women's Hospital Long Beach", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93636', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': "Valley Children's Hospital", 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "UCSF Benioff Children's Hospital Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94611', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Oakland', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital Stanford University", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Medical Center Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Comprehensive Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital - San Diego", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center-Parnassus', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center-Mission Bay', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '93102', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Santa Barbara Cottage Hospital', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 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