Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT00085202
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2004-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D018335', 'term': 'Rhabdoid Tumor'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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': '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'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@stjude.org', 'phone': '866-278-5833', 'title': 'Amar Gajjar, MD', 'organization': "St. Jude Children's Research Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The study participants for Secondary Outcome Measure #4 were randomized to standard-of-care group vs. reading intervention after medical treatment. The participants were a subset of patients who contributed to the primary aim and who signed a separate consent form distinct from the main medical treatment consent. They were then randomly assigned to either the standard-of-care group (SOC) or to the reading intervention (RI) group.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) are reported through 9/17/2013 and include all grade 3, 4 and 5 events occurring during treatment to 30 days after treatment end, and events occurring >30 days after treatment end and felt to be possibly related to protocol treatment.', 'description': 'Per protocol, Grade 3 and 4 hematologic toxicities, grade 3 and 4 electrolyte abnormalities, and total parenteral nutrition or intravenous fluids administered to prevent significant weight loss/malnutrition were not collected if they occurred from the beginning of radiation therapy through the end of 4 courses of high dose chemotherapy.', 'eventGroups': [{'id': 'EG000', 'title': 'Average-Risk Group', 'description': "Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \\<1.5 cm\\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \\<1.5 cm\\^2).", 'otherNumAtRisk': 269, 'otherNumAffected': 236, 'seriousNumAtRisk': 269, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'High-Risk Group', 'description': 'Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm\\^2) at the primary site after surgery.', 'otherNumAtRisk': 144, 'otherNumAffected': 118, 'seriousNumAtRisk': 144, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Febrile neutropenia', 'notes': 'Fever of unknown origin without clinically or microbiologically documented infection (ANC \\<1.0 x 10e9/L).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 383, 'numAffected': 172}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 148, 'numAffected': 77}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection, blood', 'notes': 'Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 76, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 28, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 63, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 29, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Allergic reaction/hypersensitivity (including drug fever)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 54, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 32, 'numAffected': 23}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain, abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 37, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 30, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 30, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection - other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 33, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 36, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Colitis, infectious (e.g., Clostridium difficile)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 28, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils, blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 30, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC, blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 23, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 19, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils, catheter-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 25, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection, catheter-related', 'notes': 'Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, pulmonary/upper respiratory, nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 16, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain, head/headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hearing: patients with/without baseline audiogram and enrolled in a monitoring program', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Allergic reaction/hypersensitivity (including drug fever)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Supraventricular and nodal arrhythmia - sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardiac general - other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pericardial effusion (non-malignant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombotic microangiopathy', 'notes': 'e.g., thrombotic thrombocytopenic purpura (TTP) or hemolytic uremic syndrome (HUS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Death not associated with CTCAE term, death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage/bleeding - other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Febrile neutropenia', 'notes': 'Fever of unknown origin without clinically or microbiologically documented infection (ANC \\<1.0 x 10e9/L).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection, blood', 'notes': 'Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils, blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils, lung (pneumonia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils, meninges (meningitis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils, wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC, meninges (meningitis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC, wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Acidosis (metabolic or respiratory)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Musculoskeletal/soft tissue - other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'CNS cerebrovascular ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'CNS necrosis/cystic progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cognitive disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leak, cerebrospinal fluid (CSF)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leukoencephalopathy (radiographic findings)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Personality/behavioral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Somnolence/depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Syncope (fainting)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Adult Respiratory Distress Syndrome (ARDS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pleural effusion (non-malignant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pneumonitis/pulmonary infiltrates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pulmonary fibrosis (radiographic changes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pulmonary/upper respiratory - other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Syndromes - other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of supratentorial primitive neuroectodermal tumor (PNET), PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma), or atypical teratoid rhabdoid tumor (ATRT) were not included in the analysis of ERBB2 tumors.'}, {'id': 'OG001', 'title': 'Average-Risk Group', 'description': 'Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa. Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \\<1.5 cm\\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \\<1.5 cm\\^2).'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm\\^2) at the primary site after surgery.'}], 'classes': [{'title': 'Positive ERBB2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '79.2', 'groupId': 'OG000', 'lowerLimit': '70.4', 'upperLimit': '88.0'}, {'value': '83.3', 'groupId': 'OG001', 'lowerLimit': '73.5', 'upperLimit': '93.1'}, {'value': '69.6', 'groupId': 'OG002', 'lowerLimit': '50.8', 'upperLimit': '88.4'}]}]}, {'title': 'Negative ERBB2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000', 'lowerLimit': '76.9', 'upperLimit': '96.5'}, {'value': '93.5', 'groupId': 'OG001', 'lowerLimit': '85.1', 'upperLimit': '100'}, {'value': '71.4', 'groupId': 'OG002', 'lowerLimit': '48.9', 'upperLimit': '93.9'}]}]}], 'analyses': [{'pValue': '0.8001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5195', 'groupIds': ['OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7696', 'groupIds': ['OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '2 years after tumor cell analysis in 122 participants', 'description': 'The relationship between ERBB2 protein expression in tumors and progression-free survival was assessed in 122 participants with a diagnosis of medulloblastoma and with ERBB2 protein assessments. If the ERBB2 value was greater than zero, the ERBB2 was defined as positive for the participant. If the ERBB2 value was zero, the ERBB2 was defined as negative. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.', 'unitOfMeasure': 'probability of PFS at 2 years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ERBB2 Positive & Average Risk', 'description': '54 participants who were ERBB2 positive and in the average risk group.'}, {'id': 'OG001', 'title': 'ERBB2 Positive & High Risk', 'description': '23 participants who were ERBB2 positive and in the high risk group'}, {'id': 'OG002', 'title': 'ERBB2 Negative & Average Risk', 'description': '31 participants who were ERBB2 negative and in the average risk group'}, {'id': 'OG003', 'title': 'ERBB2 Negative & High Risk', 'description': '14 participants who were ERBB2 negative and in the high risk group'}], 'classes': [{'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '93.1'}, {'value': '69.6', 'groupId': 'OG001', 'lowerLimit': '50.8', 'upperLimit': '88.4'}, {'value': '93.5', 'groupId': 'OG002', 'lowerLimit': '85.1', 'upperLimit': '100'}, {'value': '71.4', 'groupId': 'OG003', 'lowerLimit': '48.9', 'upperLimit': '93.9'}]}]}], 'analyses': [{'pValue': '0.0206', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '2 years after tumor cell analysis in 122 participants', 'description': '122 participants with a diagnosis of medulloblastoma were grouped by ERBB2 positive/negative assessment and risk group into 4 groups. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.', 'unitOfMeasure': 'probability of PFS at 2 years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was completed for the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Frequency of Mutations Associated With SHH and WNT Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'SHH Pathway - In/Del Somatic', 'description': 'Tissue from this subgroup of patients was analyzed for somatic insertion/deletion (In/Del).'}, {'id': 'OG001', 'title': 'WNT Pathway - In/Del Somatic', 'description': 'Tissue from this subgroup of patients was analyzed for somatic insertion/deletion (In/Del).'}, {'id': 'OG002', 'title': 'SHH Pathway - In/Del Germline', 'description': 'Tissue from this subgroup of patients was analyzed for germline insertion/deletion (In/Del).'}, {'id': 'OG003', 'title': 'WNT Pathway - In/Del Germline', 'description': 'Tissue from this subgroup of patients was analyzed for germline insertion/deletion (In/Del).'}, {'id': 'OG004', 'title': 'SHH Pathway - SNV Somatic', 'description': 'Tissue from this subgroup of patients was analyzed for somatic single nucleotide variation (SNV).'}, {'id': 'OG005', 'title': 'WNT Pathway - SNV Somatic', 'description': 'Tissue from this subgroup of patients was analyzed for somatic single nucleotide variation (SNV).'}, {'id': 'OG006', 'title': 'SHH Pathway - SNV Germline', 'description': 'Tissue from this subgroup of patients was analyzed for germline single nucleotide variation (SNV).'}, {'id': 'OG007', 'title': 'WNT Pathway - SNV Germline', 'description': 'Tissue from this subgroup of patients was analyzed for germline single nucleotide variation (SNV).'}], 'classes': [{'title': 'PTCH1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'DDX3X', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'TP53', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'KMT2D', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'SUFU', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'CREBBP', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'GLI2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'TCF4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'PTEN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'KMT2C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'FBXW7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'GSE1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'CTNNB1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'SMARCA4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'PIK3CA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'APC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'EPHA7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'ARID1A', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'ARID2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'ATM', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'BRCA2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 3.5 years following completion of accrual', 'description': 'The frequency of mutations for the main genes associated with SHH and WNT tumors identified via targeted sequencing based on formalin fixed paraffin embedded material is provided.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with WNT and SHH tumors with available tissue for targeted sequencing were analyzed for frequency of mutation. WNT and SHH subgroups were identified by methylation profiling.'}, {'type': 'SECONDARY', 'title': 'Reading Decoding Composite Scores in the Intervention and Standard of Care Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'A COMPUTER-BASED TRAINING SYSTEM SPECIFICALLY TARGETING LANGUAGE, READING, AND LEARNING SKILLS (FAST FORWORD®, SCIENTIFIC LEARNING CORPORATION)'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'THE CURRENT STANDARD OF CARE ON READING DECODING SKILLS'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '104.1', 'spread': '1.902', 'groupId': 'OG000'}, {'value': '102.4', 'spread': '2.604', 'groupId': 'OG001'}]}]}, {'title': 'Change over time', 'categories': [{'measurements': [{'value': '-1.51', 'spread': '0.4849', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '0.4883', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6231', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change over time', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5720', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '5 years postdiagnosis', 'description': 'SOC is standard-of-Care control group. Patients randomly assigned to the control group received the current standard of care. RI is Reading Intervention Group. Patients randomly assigned to Reading Intervention Group which is with The Fast ForWord program. Assessment of reading decoding was completed using the Woodcock Johnson, Third Edition (WJIII) Tests of Achievement (Woodcock, McGraw, \\& Mather, 2001), with particular attention given to the reading and reading-related abilities. Two subtests were completed: (1) Letter-Word Identification, and (2) Word Attack, a test requiring the patient to read phonologically regular nonwords. The combination of these two subtests provided a standardized composite score of overall reading decoding ability with a population mean of 100 and a standard deviation of 15. Scores of 90-110 are considered to be in the average range, while those 80-89 are considered low-average (refer: Journal of Pediatric Psychology 39(4) pp. 450-458, 2014).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 126 MB patients enrolled, 41 were not eligible. This left 85 patients considered eligible for the randomization study. Of the 85 eligible patients,81 were randomized to either SOC (n= 38) or to RI (n =43). The parents of only four patients did not consent to the intervention study. Two patients randomized to the RI group, and four patients in the SOC group, were excluded due to having only a single assessment, which resulted in 75 patients (RI=41, SOC=34) over a 5-year follow-up period.'}, {'type': 'SECONDARY', 'title': 'Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Average-Risk Group', 'description': 'Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa. Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \\<1.5 cm\\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \\<1.5 cm\\^2).'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Annually for 6 years post irradiation', 'description': 'To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included 100 average risk participants with a diagnosis of medulloblastoma who had cumulative radiotherapy dose profiles and treatment failure volumes data available. All participants included in analysis who were still at risk and on-study were followed for a minimum of 6 years. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Associative Memory for Two Risk Group at Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Average Risk Group', 'description': 'Average-Risk Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa. Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \\<1.5 cm\\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \\<1.5 cm\\^2).'}, {'id': 'OG001', 'title': 'High Risk Group', 'description': 'Participants assigned to the high- risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm\\^2) at the primary site after surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.61', 'spread': '22.25', 'groupId': 'OG000'}, {'value': '98.04', 'spread': '18.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At enrollment', 'description': 'Assessment of associative memory at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Children with medulloblastoma who were age 3-21 years at diagnosis and were enrolled on SJMB03 at St Jude Children's Research Hospital. Patients were excluded if the cumulative RT plan (Craniospinal Irradiation (CSI) and boost) could not be retrieved; if the baseline preRT Magnetic Resonance Image (MRI) scan was of poor quality, preventing delineation of brain substructures ; or if the patient had completed fewer than two specific neurocognitive evaluations for this objective."}, {'type': 'SECONDARY', 'title': 'Associative Memory for Two Risk Group at 5 Years After Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Average Risk Group', 'description': 'Average-Risk Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa. Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \\<1.5 cm\\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \\<1.5 cm\\^2).'}, {'id': 'OG001', 'title': 'High Risk Group', 'description': 'Participants assigned to the high- risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm\\^2) at the primary site after surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.73', 'spread': '16.94', 'groupId': 'OG000'}, {'value': '93.58', 'spread': '13.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 5 years after enrollment', 'description': 'Assessment of associative memory at 5 years after enrollment. Assessment of associative memory score at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Children with medulloblastoma who were age 3-21 years at diagnosis and were enrolled on SJMB03 at St Jude Children's Research Hospital. Patients were excluded if the cumulative RT plan (Craniospinal Irradiation (CSI) and boost) could not be retrieved; if the baseline preRT Magnetic Resonance Image (MRI) scan was of poor quality, preventing delineation of brain substructures; or if the patient had completed fewer than two specific neurocognitive evaluations for this objective."}, {'type': 'SECONDARY', 'title': 'Processing Speed for Two Risk Group at Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Average Risk Group', 'description': 'Average-Risk Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa. Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \\<1.5 cm\\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \\<1.5 cm\\^2).'}, {'id': 'OG001', 'title': 'High Risk Group', 'description': 'Participants assigned to the high- risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm\\^2) at the primary site after surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.98', 'spread': '18.53', 'groupId': 'OG000'}, {'value': '87.29', 'spread': '19.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At enrollment', 'description': 'Assessment of Processing Speed at enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Children with medulloblastoma who were age 3-21 years at diagnosis and were enrolled on SJMB03 at St Jude Children's Research Hospital. Patients were excluded if the cumulative RT plan (Craniospinal Irradiation (CSI) and boost) could not be retrieved; if the baseline preRT Magnetic Resonance Image (MRI) scan was of poor quality, preventing delineation of brain substructures; or if the patient had completed fewer than two specific neurocognitive evaluations for this objective."}, {'type': 'SECONDARY', 'title': 'Processing Speed for Two Risk Group at 5 Years After Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Average Risk Group', 'description': 'Average-Risk Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa. Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \\<1.5 cm\\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \\<1.5 cm\\^2).'}, {'id': 'OG001', 'title': 'High Risk Group', 'description': 'Participants assigned to the high- risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm\\^2) at the primary site after surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.21', 'spread': '24.36', 'groupId': 'OG000'}, {'value': '75.71', 'spread': '25.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 5 years after enrollment', 'description': 'Assessment of Processing Speed at 5 years after enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Children with medulloblastoma who were age 3-21 years at diagnosis and were enrolled on SJMB03 at St Jude Children's Research Hospital. Patients were excluded if the cumulative RT plan (Craniospinal Irradiation (CSI) and boost) could not be retrieved; if the baseline preRT Magnetic Resonance Image (MRI) scan was of poor quality, preventing delineation of brain substructures; or if the patient had completed fewer than two specific neurocognitive evaluations for this objective."}, {'type': 'SECONDARY', 'title': 'Perceptual Speed for Two Risk Group at Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Average Risk Group', 'description': 'Average-Risk Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa. Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \\<1.5 cm\\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \\<1.5 cm\\^2).'}, {'id': 'OG001', 'title': 'High Risk Group', 'description': 'Participants assigned to the high- risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm\\^2) at the primary site after surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.06', 'spread': '19.99', 'groupId': 'OG000'}, {'value': '90.04', 'spread': '18.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At enrollment', 'description': 'Assessment of Perceptual Speed at enrollment. It measures rapidly locating and circling identical numbers from a set of numbers which reflects perceptual speed. Mean=100, SD=15, Average Range 85-115. Higher is better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Children with medulloblastoma who were age 3-21 years at diagnosis and were enrolled on SJMB03 at St Jude Children's Research Hospital. Patients were excluded if the cumulative RT plan (Craniospinal Irradiation (CSI) and boost) could not be retrieved; if the baseline preRT Magnetic Resonance Image (MRI) scan was of poor quality, preventing delineation of brain substructures; or if the patient had completed fewer than two specific neurocognitive evaluations for this objective."}, {'type': 'SECONDARY', 'title': 'Perceptual Speed for Two Risk Group at 5 Years After Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Average Risk Group', 'description': 'Average-Risk Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa. Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \\<1.5 cm\\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \\<1.5 cm\\^2).'}, {'id': 'OG001', 'title': 'High Risk Group', 'description': 'Participants assigned to the high- risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm\\^2) at the primary site after surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.68', 'spread': '21.58', 'groupId': 'OG000'}, {'value': '72.29', 'spread': '27.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 5 years after enrollment', 'description': 'Assessment of Perceptual Speed at 5 years after enrollment. It measures rapidly locating and circling identical numbers from a set of numbers which reflects perceptual speed. Mean=100, SD=15, Average Range 85-115. Higher is better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Children with medulloblastoma who were age 3-21 years at diagnosis and were enrolled on SJMB03 at St Jude Children's Research Hospital. Patients were excluded if the cumulative RT plan (Craniospinal Irradiation (CSI) and boost) could not be retrieved; if the baseline preRT Magnetic Resonance Image (MRI) scan was of poor quality, preventing delineation of brain substructures; or if the patient had completed fewer than two specific neurocognitive evaluations for this objective."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Average-Risk Group', 'description': "Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \\<1.5 cm\\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \\<1.5 cm\\^2)."}, {'id': 'FG001', 'title': 'High-Risk Group', 'description': 'Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm\\^2) at the primary site after surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '269'}, {'groupId': 'FG001', 'numSubjects': '144'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Still on therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Bone involvement confirmed by bone scan', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Excessive toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Non-specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}], 'recruitmentDetails': '416 participants were enrolled between 9/9/2003 and 3/7/2013.', 'preAssignmentDetails': 'Of the 416 participants enrolled, three were ineligible and taken off study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '413', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Average-Risk Group', 'description': "Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \\<1.5 cm\\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \\<1.5 cm\\^2)."}, {'id': 'BG001', 'title': 'High-Risk Group', 'description': 'Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm\\^2) at the primary site after surgery.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.15', 'spread': '4.08', 'groupId': 'BG000'}, {'value': '8.66', 'spread': '3.93', 'groupId': 'BG001'}, {'value': '8.98', 'spread': '4.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.42', 'groupId': 'BG000', 'lowerLimit': '3.06', 'upperLimit': '21.56'}, {'value': '7.87', 'groupId': 'BG001', 'lowerLimit': '3.13', 'upperLimit': '20.43'}, {'value': '8.33', 'groupId': 'BG002', 'lowerLimit': '3.06', 'upperLimit': '21.56'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants had a diagnosis of medulloblastoma, supratentorial primitive neuroectodermal tumor (PNET), PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma), or atypical teratoid rhabdoid tumor (ATRT).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 416}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-11', 'studyFirstSubmitDate': '2004-06-10', 'resultsFirstSubmitDate': '2013-11-04', 'studyFirstSubmitQcDate': '2004-06-10', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-01-09', 'studyFirstPostDateStruct': {'date': '2004-06-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors', 'timeFrame': '2 years after tumor cell analysis in 122 participants', 'description': 'The relationship between ERBB2 protein expression in tumors and progression-free survival was assessed in 122 participants with a diagnosis of medulloblastoma and with ERBB2 protein assessments. If the ERBB2 value was greater than zero, the ERBB2 was defined as positive for the participant. If the ERBB2 value was zero, the ERBB2 was defined as negative. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.'}, {'measure': 'Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group.', 'timeFrame': '2 years after tumor cell analysis in 122 participants', 'description': '122 participants with a diagnosis of medulloblastoma were grouped by ERBB2 positive/negative assessment and risk group into 4 groups. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.'}, {'measure': 'Frequency of Mutations Associated With SHH and WNT Tumors', 'timeFrame': 'within 3.5 years following completion of accrual', 'description': 'The frequency of mutations for the main genes associated with SHH and WNT tumors identified via targeted sequencing based on formalin fixed paraffin embedded material is provided.'}], 'secondaryOutcomes': [{'measure': 'Reading Decoding Composite Scores in the Intervention and Standard of Care Groups', 'timeFrame': '5 years postdiagnosis', 'description': 'SOC is standard-of-Care control group. Patients randomly assigned to the control group received the current standard of care. RI is Reading Intervention Group. Patients randomly assigned to Reading Intervention Group which is with The Fast ForWord program. Assessment of reading decoding was completed using the Woodcock Johnson, Third Edition (WJIII) Tests of Achievement (Woodcock, McGraw, \\& Mather, 2001), with particular attention given to the reading and reading-related abilities. Two subtests were completed: (1) Letter-Word Identification, and (2) Word Attack, a test requiring the patient to read phonologically regular nonwords. The combination of these two subtests provided a standardized composite score of overall reading decoding ability with a population mean of 100 and a standard deviation of 15. Scores of 90-110 are considered to be in the average range, while those 80-89 are considered low-average (refer: Journal of Pediatric Psychology 39(4) pp. 450-458, 2014).'}, {'measure': 'Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa', 'timeFrame': 'Annually for 6 years post irradiation', 'description': 'To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation.'}, {'measure': 'Associative Memory for Two Risk Group at Enrollment', 'timeFrame': 'At enrollment', 'description': 'Assessment of associative memory at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better.'}, {'measure': 'Associative Memory for Two Risk Group at 5 Years After Enrollment', 'timeFrame': 'At 5 years after enrollment', 'description': 'Assessment of associative memory at 5 years after enrollment. Assessment of associative memory score at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better.'}, {'measure': 'Processing Speed for Two Risk Group at Enrollment', 'timeFrame': 'At enrollment', 'description': 'Assessment of Processing Speed at enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better.'}, {'measure': 'Processing Speed for Two Risk Group at 5 Years After Enrollment', 'timeFrame': 'At 5 years after enrollment', 'description': 'Assessment of Processing Speed at 5 years after enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better.'}, {'measure': 'Perceptual Speed for Two Risk Group at Enrollment', 'timeFrame': 'At enrollment', 'description': 'Assessment of Perceptual Speed at enrollment. It measures rapidly locating and circling identical numbers from a set of numbers which reflects perceptual speed. Mean=100, SD=15, Average Range 85-115. Higher is better.'}, {'measure': 'Perceptual Speed for Two Risk Group at 5 Years After Enrollment', 'timeFrame': 'At 5 years after enrollment', 'description': 'Assessment of Perceptual Speed at 5 years after enrollment. It measures rapidly locating and circling identical numbers from a set of numbers which reflects perceptual speed. Mean=100, SD=15, Average Range 85-115. Higher is better.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['untreated childhood medulloblastoma', 'untreated childhood supratentorial primitive neuroectodermal tumor', 'childhood atypical teratoid/rhabdoid tumor', 'untreated childhood pineoblastoma'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'referencesModule': {'references': [{'pmid': '34714708', 'type': 'DERIVED', 'citation': 'Acharya S, Guo Y, Patni T, Li Y, Wang C, Gargone M, Ashford JM, Wilson L, Faught A, Reddick WE, Patay Z, Gajjar A, Conklin HM, Merchant TE. Association Between Brain Substructure Dose and Cognitive Outcomes in Children With Medulloblastoma Treated on SJMB03: A Step Toward Substructure-Informed Planning. J Clin Oncol. 2022 Jan 1;40(1):83-95. doi: 10.1200/JCO.21.01480. Epub 2021 Oct 29.'}, {'pmid': '33743477', 'type': 'DERIVED', 'citation': 'Partanen M, Anghelescu DL, Hall L, Schreiber JE, Rossi M, Gajjar A, Jacola LM. Longitudinal associations between exposure to anesthesia and neurocognitive functioning in pediatric medulloblastoma. Eur J Cancer. 2021 May;148:103-111. doi: 10.1016/j.ejca.2021.02.010. Epub 2021 Mar 17.'}, {'pmid': '33502920', 'type': 'DERIVED', 'citation': 'Kumar R, Smith KS, Deng M, Terhune C, Robinson GW, Orr BA, Liu APY, Lin T, Billups CA, Chintagumpala M, Bowers DC, Hassall TE, Hansford JR, Khuong-Quang DA, Crawford JR, Bendel AE, Gururangan S, Schroeder K, Bouffet E, Bartels U, Fisher MJ, Cohn R, Partap S, Kellie SJ, McCowage G, Paulino AC, Rutkowski S, Fleischhack G, Dhall G, Klesse LJ, Leary S, Nazarian J, Kool M, Wesseling P, Ryzhova M, Zheludkova O, Golanov AV, McLendon RE, Packer RJ, Dunham C, Hukin J, Fouladi M, Faria CC, Pimentel J, Walter AW, Jabado N, Cho YJ, Perreault S, Croul SE, Zapotocky M, Hawkins C, Tabori U, Taylor MD, Pfister SM, Klimo P Jr, Boop FA, Ellison DW, Merchant TE, Onar-Thomas A, Korshunov A, Jones DTW, Gajjar A, Ramaswamy V, Northcott PA. Clinical Outcomes and Patient-Matched Molecular Composition of Relapsed Medulloblastoma. J Clin Oncol. 2021 Mar 1;39(7):807-821. doi: 10.1200/JCO.20.01359. Epub 2021 Jan 27.'}, {'pmid': '33405951', 'type': 'DERIVED', 'citation': 'Gajjar A, Robinson GW, Smith KS, Lin T, Merchant TE, Chintagumpala M, Mahajan A, Su J, Bouffet E, Bartels U, Schechter T, Hassall T, Robertson T, Nicholls W, Gururangan S, Schroeder K, Sullivan M, Wheeler G, Hansford JR, Kellie SJ, McCowage G, Cohn R, Fisher MJ, Krasin MJ, Stewart CF, Broniscer A, Buchhalter I, Tatevossian RG, Orr BA, Neale G, Klimo P Jr, Boop F, Srinivasan A, Pfister SM, Gilbertson RJ, Onar-Thomas A, Ellison DW, Northcott PA. Outcomes by Clinical and Molecular Features in Children With Medulloblastoma Treated With Risk-Adapted Therapy: Results of an International Phase III Trial (SJMB03). J Clin Oncol. 2021 Mar 1;39(7):822-835. doi: 10.1200/JCO.20.01372. Epub 2021 Jan 6.'}, {'pmid': '25665007', 'type': 'DERIVED', 'citation': 'Xu H, Robinson GW, Huang J, Lim JY, Zhang H, Bass JK, Broniscer A, Chintagumpala M, Bartels U, Gururangan S, Hassall T, Fisher M, Cohn R, Yamashita T, Teitz T, Zuo J, Onar-Thomas A, Gajjar A, Stewart CF, Yang JJ. Common variants in ACYP2 influence susceptibility to cisplatin-induced hearing loss. Nat Genet. 2015 Mar;47(3):263-6. doi: 10.1038/ng.3217. Epub 2015 Feb 9.'}], 'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}, {'url': 'http://www.stjude.org/protocols', 'label': 'Clinical Trials Open at St. Jude'}]}, 'descriptionModule': {'briefSummary': 'Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. It is not yet known which radiation therapy regimen combined with chemotherapy and donor stem cell transplant is more effective in treating medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor.\n\nThis phase III trial is studying two different regimens of radiation therapy when given together with chemotherapy and autologous stem cell transplant to see how well they work in treating patients with newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor.\n\nPRIMARY OBJECTIVE:\n\n* To assess the relationship between ERBB2 protein expression in tumors and progression-free survival probability for patients with medulloblastoma.\n* To estimate the frequency of mutations associated with SHH and WNT tumors (as defined by gene expression profiling) via targeted sequencing performed in an independent cohort of WNT and SHH tumors (also defined by gene expression profiling).', 'detailedDescription': 'SECONDARY OBJECTIVES:\n\n* To compare the effects of a computer-based training system specifically targeting language, reading, and learning skills (Fast ForWord, Scientific Learning Corporation) with the current standard of care on reading decoding skills as measured by individual academic testing.\n* To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation.\n* To correlate radiation dosimetry of target and normal tissues with rate and patterns of failure and longitudinal measures of audiometric, endocrine and cognitive effects.\n\nEXPLORATORY OBJECTIVES:\n\n* To estimate the change in neuropsychological performance from the neuropsychology assessment battery (intellect, academic achievement and cognitive ability) and examine the relationship of these changes to risk group, age at diagnosis, and parent measures.\n* To evaluate the differences between neurotoxicity in the average-risk patient group with that in the high-risk group through qMRI, and fMRI.\n* To develop or refine novel models relating impact of medulloblastoma therapy on neurocognitive performance to quantitative and functional neuroimaging measures.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to disease risk (high-risk disease vs average-risk disease).\n\nPatients in both strata undergo peripheral blood stem cell or bone marrow harvest.\n\n* Stratum 1 (high-risk group):\n\n * Radiotherapy: Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks.\n * High-dose chemotherapy and autologous stem cell transplantation (SCT): Six weeks after the completion of radiotherapy, patients receive high-dose chemotherapy comprising vincristine IV followed by cisplatin IV over 6 hours on day -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Patients undergo autologous SCT on day 0. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 1 and continuing until blood counts recover. Patients receive vincristine IV on day 6. High-dose chemotherapy and autologous SCT repeat every 4 weeks for 3 additional courses in the absence of unacceptable toxicity.\n* Stratum 2 (average-risk group):\n\n * Radiotherapy: Patients undergo craniospinal radiotherapy as in stratum 1, but at a lower dose.\n * High-dose chemotherapy and autologous SCT: Patients receive high-dose chemotherapy, autologous SCT, G-CSF, and post-transplantation vincristine as in stratum 1.\n\nSome patients undergo a neuropsychology assessment at baseline, before chemotherapy, and then annually for 5 years.\n\nAfter completion of study therapy, patients are followed every 3 months until month 30 (2.5 years) after diagnosis and then every 6 months until month 72 (6 years) after diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed diagnosis of 1 of the following:\n\n * Medulloblastoma\n * Supratentorial primitive neuroectodermal tumor (PNET)\n * PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma)\n * Atypical teratoid rhabdoid tumor (ATRT)\n* Definitive surgery for CNS tumor within the past 31 days\n* Meets one of the following risk criteria:\n\n * Average-risk disease\n\n * Localized disease with no overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET or ATRT) by intraoperative observations of the neurosurgeon AND postoperative CT scan or MRI\n * T4 disease eligible if all of the following are true:\n\n * Gross total resection determined by intraoperative observations of the neurosurgeon AND postoperative CT scan or MRI\n * Residual tumor or imaging abnormality whose size is \\< 1.5 cm\\^2\n * No evidence of CNS or extraneural metastasis by MRI of the spine (with and without contrast agent) or CT-based myelogram AND by cytologic examination of the lumbar cerebral spinal fluid (CSF) 14-28 days after surgery\n * Brain stem invasion allowed in the absence of residual tumor (tumor \\< 1.5 cm\\^2 by imaging)\n * High-risk disease meeting one of the following criteria:\n\n * Metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination by imaging and/or cytologic examination of CSF)\n * Presence of residual disease \\> 1.5 cm\\^2 at the primary site after surgery\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 3 to 21 at diagnosis\n\nPerformance status\n\n* Lansky 30-100% (\\< 10 years old)\n* Karnofsky 30-100% (≥ 10 years old) (except for posterior fossa syndrome)\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Hemoglobin \\> 8 g/dL\n* WBC \\> 2,000/mm\\^3\n* Absolute neutrophil count \\> 500/mm\\^3\n* Platelet count \\> 50,000/mm\\^3\n\nHepatic\n\n* ALT \\< 5 times normal\n* Bilirubin \\< 3.0 mg/dL\n\nRenal\n\n* Creatinine \\< 2.0 mg/dL OR\n* Creatinine clearance \\> 70 mL/min\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior chemotherapy\n\nEndocrine therapy\n\n* Prior corticosteroid therapy allowed\n\nRadiotherapy\n\n* No prior radiotherapy\n\nSurgery\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00085202', 'briefTitle': 'Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor', 'orgStudyIdInfo': {'id': 'SJMB03'}, 'secondaryIdInfos': [{'id': 'NCI-2011-01185', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trial Registration Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stratum 1 (high-risk group)', 'description': 'Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks. Six weeks after the completion of radiotherapy, patients receive high-dose chemotherapy followed by autologous stem cell transplantation (SCT) and filgrastim (G-CSF) with post-transplantation vincristine. High-dose chemotherapy and autologous SCT repeat every 4 weeks for 3 additional courses in the absence of unacceptable toxicity.\n\nInterventions: vincristine, cisplatin, cyclophosphamide, autologous hematopoietic stem cell transplantation, filgrastim, radiation therapy', 'interventionNames': ['Biological: filgrastim', 'Drug: cisplatin', 'Drug: cyclophosphamide', 'Drug: vincristine', 'Procedure: autologous hematopoietic stem cell transplantation', 'Radiation: radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Stratum 2 (average-risk group)', 'description': 'Patients undergo craniospinal radiotherapy as in stratum 1, but at a lower dose. Patients receive high-dose chemotherapy, autologous SCT, G-CSF, and post-transplantation vincristine as in stratum 1.\n\nInterventions: vincristine, cisplatin, cyclophosphamide, autologous hematopoietic stem cell transplantation, filgrastim, radiation therapy', 'interventionNames': ['Biological: filgrastim', 'Drug: cisplatin', 'Drug: cyclophosphamide', 'Drug: vincristine', 'Procedure: autologous hematopoietic stem cell transplantation', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL', 'otherNames': ['Neupogen(R)', 'G-CSF'], 'description': 'Given subcutaneously', 'armGroupLabels': ['Stratum 1 (high-risk group)', 'Stratum 2 (average-risk group)']}, {'name': 'cisplatin', 'type': 'DRUG', 'otherNames': ['Platinol-AQ(R)'], 'description': 'Given IV', 'armGroupLabels': ['Stratum 1 (high-risk group)', 'Stratum 2 (average-risk group)']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan(R)'], 'description': 'Given IV', 'armGroupLabels': ['Stratum 1 (high-risk group)', 'Stratum 2 (average-risk group)']}, {'name': 'vincristine', 'type': 'DRUG', 'otherNames': ['Oncovin(R)'], 'description': 'Given IV', 'armGroupLabels': ['Stratum 1 (high-risk group)', 'Stratum 2 (average-risk group)']}, {'name': 'autologous hematopoietic stem cell transplantation', 'type': 'PROCEDURE', 'otherNames': ['autologous HSCT'], 'description': 'Patients undergo autologous stem cell transplantation', 'armGroupLabels': ['Stratum 1 (high-risk group)', 'Stratum 2 (average-risk group)']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'otherNames': ['RT', 'Craniospinal radiotherapy'], 'description': 'Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks.', 'armGroupLabels': ['Stratum 1 (high-risk group)', 'Stratum 2 (average-risk group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030-2399', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': "Sydney Children's Hospital", 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': "Children's Hospital at Westmead", 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4029', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': "Lady Cilento Children's Hospital, Brisbane", 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': "Royal Children's Hospital", 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': 'M5S 0A4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Amar Gajjar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}