Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-01 @ 3:17 AM
Study NCT ID:
NCT00105560
Status:
COMPLETED
Last Update Posted:
2021-12-28
First Post:
2005-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'NTARBELL@mgh.harvard.edu', 'phone': '617-724-1836', 'title': 'Dr. Nancy Tarbell, Pediatric Radiation Oncologist', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, median duration of 7 years', 'description': 'Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.', 'eventGroups': [{'id': 'EG000', 'title': 'Radiation Therapy', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 59, 'seriousNumAtRisk': 59, 'deathsNumAffected': 13, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 59}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 35}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Radiation dermatitis (scalp or back)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Weight Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 42}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cataracts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 16}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'CNS brainstem injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Scoliosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Truncal muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nystagmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'esophhagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cumulative Incidence of Ototoxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy - 3 Years Follow-up', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}, {'id': 'OG001', 'title': 'Radiation Therapy - 5 Years Follow-up', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}, {'id': 'OG002', 'title': 'Radiation Therapy - 7 Years Follow-up', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}], 'classes': [{'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '25'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '29'}, {'value': '16', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '29'}]}]}, {'title': 'Standard Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '31'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '38'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '38'}]}]}, {'title': 'Intermediate-high risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '29'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '29'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '29'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '19'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '19'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '19'}]}]}, {'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '40'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '49'}, {'value': '27', 'groupId': 'OG002', 'lowerLimit': '9', 'upperLimit': '49'}]}]}, {'title': '<8 years old', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '32'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '38'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '38'}]}]}, {'title': '≥8 years old', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '25'}]}]}, {'title': 'Vetriculoperitoneal shunt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '53'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '53'}, {'value': '22', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '53'}]}]}, {'title': 'No vetriculoperitoneal shunt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '24'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '29'}, {'value': '14', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '29'}]}]}, {'title': 'Cisplatin total dose ≤300 mg/m2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '46'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '46'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '46'}]}]}, {'title': 'Cisplatin total dose >300 mg/m2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '28'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '35'}, {'value': '17', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '35'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 Years, 5 years, 7 years, 10 years', 'description': 'Percentage participants who experienced ototoxicity as measured by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0 after the completion of radiation therapy in the overall participant population and by baseline measure subgroups. Incidence is shown after follow-up of 3 years, 5 years, 7 years, and 10 years.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall study population after the stated durations of follow-up. Follow-up is ongoing and data is not yet available for the 10 year time point.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy - Overall Study Population', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}, {'id': 'OG001', 'title': 'Radiation Therapy - Standard Risk Group', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}, {'id': 'OG002', 'title': 'Radiation Therapy Intermediate-High Risk', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}], 'classes': [{'title': 'Any hormone deficit', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '39'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '43'}, {'value': '25', 'groupId': 'OG002', 'lowerLimit': '9', 'upperLimit': '46'}]}]}, {'title': 'Growth hormone deficit', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '33'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '37'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '40'}]}]}, {'title': 'Thyroid deficiency', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '22'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '22'}, {'value': '15', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '34'}]}]}, {'title': 'Adrenal or cortisol deficit', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '13'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '10', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '28'}]}]}, {'title': 'Sex hormone deficit', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '11'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '21'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 3 years of follow-up (as determined by CTCAE 3.0). Incidence is grouped by hormone type and risk group', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 5 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy - Overall Study Population', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}, {'id': 'OG001', 'title': 'Radiation Therapy - Standard Risk Group', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}, {'id': 'OG002', 'title': 'Radiation Therapy - Intermediate-High Risk', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}], 'classes': [{'title': 'Any hormone deficit', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '67'}, {'value': '58', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '72'}, {'value': '50', 'groupId': 'OG002', 'lowerLimit': '26', 'upperLimit': '70'}]}]}, {'title': 'Growth hormone deficit', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '59'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '65'}, {'value': '40', 'groupId': 'OG002', 'lowerLimit': '18', 'upperLimit': '61'}]}]}, {'title': 'Thyroid deficiency', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '32'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '35'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '40'}]}]}, {'title': 'Adrenal or cortisol deficit', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '17'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '40'}]}]}, {'title': 'Sex hormone deficit : Overall study population', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '11'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '21'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 5 years of follow-up (as determined by CTCAE 3.0). Incidence is shown by hormone type and risk group.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy - Overall Study Population', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}, {'id': 'OG001', 'title': 'Radiation Therapy - Standard Risk Group', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}, {'id': 'OG002', 'title': 'Radiation Therapy - Intermediate-High Risk', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}], 'classes': [{'title': 'Any hormone deficit', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '75'}, {'value': '68', 'groupId': 'OG001', 'lowerLimit': '49', 'upperLimit': '82'}, {'value': '50', 'groupId': 'OG002', 'lowerLimit': '26', 'upperLimit': '70'}]}]}, {'title': 'Growth hormone deficit', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '68'}, {'value': '62', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '76'}, {'value': '40', 'groupId': 'OG002', 'lowerLimit': '18', 'upperLimit': '61'}]}]}, {'title': 'Thyroid deficiency', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '38'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '40'}, {'value': '29', 'groupId': 'OG002', 'lowerLimit': '9', 'upperLimit': '53'}]}]}, {'title': 'Adrenal or cortisol deficit', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '17'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '40'}]}]}, {'title': 'Sex hormone deficit : Overall study population', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '11'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '21'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 years', 'description': 'Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 7 years of follow-up, as determined by CTCAE 3.0. Incidence is shown by hormone type and risk group', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy - 3 Years Follow-up', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}, {'id': 'OG001', 'title': 'Radiation Therapy - 5 Years Follow-up', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}, {'id': 'OG002', 'title': 'Radiation Therapy - 7 Years Follow-up', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}], 'classes': [{'title': 'Any hormone deficit', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '39'}, {'value': '55', 'groupId': 'OG001', 'lowerLimit': '41', 'upperLimit': '67'}, {'value': '63', 'groupId': 'OG002', 'lowerLimit': '48', 'upperLimit': '75'}]}]}, {'title': 'Growth hormone deficit', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '33'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '59'}, {'value': '55', 'groupId': 'OG002', 'lowerLimit': '40', 'upperLimit': '68'}]}]}, {'title': 'Thyroid deficiency', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '22'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '32'}, {'value': '26', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '38'}]}]}, {'title': 'Adrenal or cortisol deficit', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '13'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '17'}, {'value': '9', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '17'}]}]}, {'title': 'Sex hormone deficit', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '11'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '11'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '11'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years, 5 years, 7 years', 'description': 'percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) as determined by CTCAE 3.0) at year 3, year 5, and year 7 of follow-up.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change Per-Year in Neurocognitive Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}], 'classes': [{'title': 'FSIQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-2.1', 'upperLimit': '-0.9'}]}]}, {'title': 'VCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '-0.7'}]}]}, {'title': 'PRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-.4', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '0.3'}]}]}, {'title': 'Working Memory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-1.8', 'upperLimit': '0.3'}]}]}, {'title': 'Processing speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-3.2', 'upperLimit': '-1.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1, 3, 5, 7 years', 'description': 'The mean change per-year in neurocognitive outcomes as assessed by Wechsler Intelligence Scale for Children version 4 (WISC-IV). The test measures the Full Scale Intelligence Quotient (FSIQ) of children with the use of four indices; the Verbal Comprehension Index (VCI), Perceptual Reasoning Index (PRI), working memory test, and a processing speed test. FSIQ and the four indices are all assessed on a bell curve scale that has an average score of 100 and standard deviation of 15 points in the general population, meaning on average 68% of test takers would be within +/- 15 points of 100 and 95% within +/- 30 points. Higher scores represent higher intelligence and lower score represent reduced intelligence. Participants were assessed for changes in score with the use of repeated testing during a median follow-up time of 5.2 years. Repeated measures were taken at baseline, 1, 3, 5, and 7 years or until the participant was not available for evaluation (whichever comes first).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The study participants that were evaluated for changes in neurocognitive outcomes'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy - 5 Years Follow-up', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}, {'id': 'OG001', 'title': 'Radiation Therapy - 7 Years Follow-up', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}], 'classes': [{'title': 'All Participants', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '88'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '61', 'upperLimit': '84'}]}]}, {'title': 'Standard Risk', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '93'}, {'value': '81', 'groupId': 'OG001', 'lowerLimit': '64', 'upperLimit': '91'}]}]}, {'title': 'Intermediate-high risk', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '85'}, {'value': '63', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '81'}]}]}, {'title': 'Classic or desmoplastic histological subtype', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '89'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '61', 'upperLimit': '85'}]}]}, {'title': 'Anaplastic or large cell histological subtype', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '93'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '31', 'upperLimit': '93'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years, 7 years, 10 years', 'description': 'The percentage of participants with progression free survival after five, seven, and ten years in the overall population and by risk and histological group.', 'unitOfMeasure': 'percentage of participants surviving', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Follow-up is ongoing and data is not yet available for the 10 year follow-up time point.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy - 5 Years Follow-up', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}, {'id': 'OG001', 'title': 'Radiation Therapy - 7 Years Follow-up', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}], 'classes': [{'title': 'All Participants', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '90'}, {'value': '81', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '89'}]}]}, {'title': 'Standard Risk', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '94'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': '94'}]}]}, {'title': 'Intermediate-high risk', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '89'}, {'value': '68', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '84'}]}]}, {'title': 'Classic or desmoplastic histological subtype', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '92'}, {'value': '82', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '90'}]}]}, {'title': 'Anaplastic or large cell histological subtype', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '93'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '31', 'upperLimit': '93'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years, 7 years, 10 years', 'description': 'the percentage of participants surviving after five and seven years and at the end of follow-up in the overall population. Survival is shown by risk and histological group.', 'unitOfMeasure': 'percentage of participants surviving', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Follow-up for the 10 year follow-up is still ongoing and the data is not yet available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Radiation Therapy', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Radiation Therapy', 'description': 'radiation therapy: Radiation therapy with proton beam to standard doses'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'BG000', 'lowerLimit': '5.1', 'upperLimit': '9.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '< 8 Years', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}, {'title': '≥ 8 Years', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Histological Subtype (Dominant Pattern)', 'classes': [{'title': 'Classic', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': 'Desmoplastic or Nodular Variant', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Anaplastic or Large Cell Variant', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Risk Group', 'classes': [{'title': 'Standard', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}, {'title': 'Intermediate', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'High', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Intermediate risk is defined as M0 patients with \\<1·5 cm² of residual disease but with anaplastic or large cell variant. If residual disease at the primary site was greater than or equal to 1·5 cm² on axial MRI, then they would be classified as high risk if they had no other evidence of metastatic disease.', 'unitOfMeasure': 'Participants'}, {'title': 'Posterior Fossa Syndrome', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ventriculoperitoneal Shunt', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Enrolled on a Children's Oncology Group Protocol", 'classes': [{'title': 'Yes : ACNS0331', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Yes : ACNS0332', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Yes : ACNS0334', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Yes : A9961', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': "The alphanumeric codes next to the 'yes' represent Children's Oncology Group protocol numbers", 'unitOfMeasure': 'participants'}, {'title': 'Boost Field', 'classes': [{'title': 'Tumor Bed Involved Field', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}, {'title': 'Posterior Fossa', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Boost Dose', 'classes': [{'title': '54 GyRBE', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}, {'title': '>54 GyRBE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Dose measured as Gray (Gy) Relative Biological Effectiveness (RBE)', 'unitOfMeasure': 'Participants'}, {'title': 'Craniospinal Radiation Doses', 'classes': [{'title': '18-27 GyRBE', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': '36 GyRBE', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypothalamus Mean Dose (D50)', 'classes': [{'title': '<40 GyRBE', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}, {'title': '≥40 GyRBE', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'D50 (the half maximal inhibitory dose) is the dose of radiation that is required for 50% inactivation of a tumor cell population.', 'unitOfMeasure': 'Participants'}, {'title': 'Cochlear Mean Dose to Each Ear (D50)', 'classes': [{'title': '<30 GyRBE', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}, {'title': '≥30 GyRBE', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Ears'}, {'title': 'Cisplatin Cumulative Dose', 'classes': [{'title': '≤300 mg/m2', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': '>300 mg/m2', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Cisplatin cumulative dose information is not available for eight of the participants', 'unitOfMeasure': 'participants'}, {'title': 'Use of Photons for <20% radiation dose', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-03', 'studyFirstSubmitDate': '2005-03-15', 'resultsFirstSubmitDate': '2017-03-26', 'studyFirstSubmitQcDate': '2005-03-15', 'lastUpdatePostDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-21', 'studyFirstPostDateStruct': {'date': '2005-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Incidence of Ototoxicity', 'timeFrame': '3 Years, 5 years, 7 years, 10 years', 'description': 'Percentage participants who experienced ototoxicity as measured by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0 after the completion of radiation therapy in the overall participant population and by baseline measure subgroups. Incidence is shown after follow-up of 3 years, 5 years, 7 years, and 10 years.'}], 'secondaryOutcomes': [{'measure': 'Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 3 Years', 'timeFrame': '3 years', 'description': 'Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 3 years of follow-up (as determined by CTCAE 3.0). Incidence is grouped by hormone type and risk group'}, {'measure': 'Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 5 Years', 'timeFrame': '5 years', 'description': 'Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 5 years of follow-up (as determined by CTCAE 3.0). Incidence is shown by hormone type and risk group.'}, {'measure': 'Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years', 'timeFrame': '7 years', 'description': 'Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 7 years of follow-up, as determined by CTCAE 3.0. Incidence is shown by hormone type and risk group'}, {'measure': 'Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years', 'timeFrame': '3 years, 5 years, 7 years', 'description': 'percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) as determined by CTCAE 3.0) at year 3, year 5, and year 7 of follow-up.'}, {'measure': 'Mean Change Per-Year in Neurocognitive Outcomes', 'timeFrame': 'Baseline, 1, 3, 5, 7 years', 'description': 'The mean change per-year in neurocognitive outcomes as assessed by Wechsler Intelligence Scale for Children version 4 (WISC-IV). The test measures the Full Scale Intelligence Quotient (FSIQ) of children with the use of four indices; the Verbal Comprehension Index (VCI), Perceptual Reasoning Index (PRI), working memory test, and a processing speed test. FSIQ and the four indices are all assessed on a bell curve scale that has an average score of 100 and standard deviation of 15 points in the general population, meaning on average 68% of test takers would be within +/- 15 points of 100 and 95% within +/- 30 points. Higher scores represent higher intelligence and lower score represent reduced intelligence. Participants were assessed for changes in score with the use of repeated testing during a median follow-up time of 5.2 years. Repeated measures were taken at baseline, 1, 3, 5, and 7 years or until the participant was not available for evaluation (whichever comes first).'}, {'measure': 'Progression Free Survival', 'timeFrame': '5 years, 7 years, 10 years', 'description': 'The percentage of participants with progression free survival after five, seven, and ten years in the overall population and by risk and histological group.'}, {'measure': 'Overall Survival', 'timeFrame': '5 years, 7 years, 10 years', 'description': 'the percentage of participants surviving after five and seven years and at the end of follow-up in the overall population. Survival is shown by risk and histological group.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['long-term effects secondary to cancer therapy in children', 'untreated childhood medulloblastoma', 'untreated childhood pineoblastoma'], 'conditions': ['Brain and Central Nervous System Tumors', 'Long-term Effects Secondary to Cancer Therapy in Children']}, 'referencesModule': {'references': [{'pmid': '26830377', 'type': 'RESULT', 'citation': 'Yock TI, Yeap BY, Ebb DH, Weyman E, Eaton BR, Sherry NA, Jones RM, MacDonald SM, Pulsifer MB, Lavally B, Abrams AN, Huang MS, Marcus KJ, Tarbell NJ. Long-term toxic effects of proton radiotherapy for paediatric medulloblastoma: a phase 2 single-arm study. Lancet Oncol. 2016 Mar;17(3):287-298. doi: 10.1016/S1470-2045(15)00167-9. Epub 2016 Jan 30.'}, {'pmid': '30118397', 'type': 'DERIVED', 'citation': 'Vatner RE, Niemierko A, Misra M, Weyman EA, Goebel CP, Ebb DH, Jones RM, Huang MS, Mahajan A, Grosshans DR, Paulino AC, Stanley T, MacDonald SM, Tarbell NJ, Yock TI. Endocrine Deficiency As a Function of Radiation Dose to the Hypothalamus and Pituitary in Pediatric and Young Adult Patients With Brain Tumors. J Clin Oncol. 2018 Oct 1;36(28):2854-2862. doi: 10.1200/JCO.2018.78.1492. Epub 2018 Aug 17.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue.\n\nPURPOSE: This phase II trial is studying how well proton beam radiation therapy works in treating young patients who have undergone biopsy or surgery for medulloblastoma or pineoblastoma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the 3-year incidence and severity of ototoxicity in young patients with medulloblastoma or pineoblastoma treated with adjuvant proton beam craniospinal and posterior fossa radiotherapy.\n* Determine the incidence of primary hypothyroidism and other endocrine dysfunction (neuroendocrine and end organ) in patients treated with this regimen.\n* Determine the incidence and severity of neurocognitive abnormalities in patients treated with this regimen.\n* Determine the acute side effects of this regimen, including esophagitis, upper and lower gastrointestinal tract disease, and weight loss, in these patients.\n* Determine the 3-year progression-free survival rate of patients treated with this regimen.\n\nOUTLINE: Patients are stratified according to risk (standard vs high).\n\nPatients receive proton beam craniospinal and posterior fossa radiotherapy once daily 5 days a week for 6-8 weeks\\*.\n\nNOTE: \\*Unless otherwise specified by a co-existing protocol.\n\nPatients undergo neurocognitive evaluation at baseline or within 3 months after completion of radiotherapy and then at 1, 3, and 5 years. Patients also undergo endocrine evaluation at baseline and then annually for 5 years; and audiology evaluation at baseline, before each course of cisplatin-based chemotherapy (if receiving this), and then annually for 5 years.\n\nAfter completion of study treatment, patients are followed every 3-6 months for 2-5 years.\n\nPROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed medulloblastoma or pineoblastoma\n\n * Standard-risk or high-risk disease\n* Must have undergone biopsy or attempted surgical resection of the tumor within the past 35 days\n* Requires craniospinal irradiation\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 3 to 21\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\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 more than 1 prior chemotherapy regimen\n* No prior IV or intrathecal methotrexate\n* No prior intrathecal thiotepa\n* Concurrent cisplatin-based chemotherapy, including chemotherapy administered on another study, allowed\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior radiotherapy\n\nSurgery\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00105560', 'briefTitle': 'Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Phase II Study of Craniospinal and Posterior Fossa Irradiation Using Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: Assessment of Acute and Long Term Sequelae', 'orgStudyIdInfo': {'id': 'CDR0000415841'}, 'secondaryIdInfos': [{'id': 'P01CA021239', 'link': 'https://reporter.nih.gov/quickSearch/P01CA021239', 'type': 'NIH'}, {'id': 'MGH-99-271', 'type': 'OTHER', 'domain': 'Massachusetts General Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiation therapy', 'description': 'This is a single arm study of radiation therapy with protons to standard doses.', 'interventionNames': ['Radiation: radiation therapy']}], 'interventions': [{'name': 'radiation therapy', 'type': 'RADIATION', 'description': 'Radiation therapy with proton beam to standard doses', 'armGroupLabels': ['Radiation therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Nancy J. Tarbell, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Radiation Oncologist', 'investigatorFullName': 'Nancy J. Tarbell, M.D.', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}