Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT00335556
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2006-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D009396', 'term': 'Wilms Tumor'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003226', 'term': 'Congresses as Topic'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D003609', 'term': 'Dactinomycin'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'resultsreportingcoordinator@childrensoncologygroup.org', 'phone': '626-447-0064', 'title': 'Results Reporting Coordinator', 'organization': "Children's Oncology Group"}, 'certainAgreement': {'otherDetails': 'Must obtain prior Sponsor approval.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Surgery', 'description': 'Surgery Only', 'otherNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'UH-1', 'description': 'Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT', 'otherNumAtRisk': 98, 'otherNumAffected': 81, 'seriousNumAtRisk': 98, 'seriousNumAffected': 19}, {'id': 'EG002', 'title': 'Window/UH-1', 'description': 'Window therapy of vincristine/irinotecan; Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT"', 'otherNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'UH-2', 'description': 'Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT', 'otherNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Regimen I', 'description': 'Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT', 'otherNumAtRisk': 78, 'otherNumAffected': 7, 'seriousNumAtRisk': 78, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Regimen DD-4A', 'description': 'Vincristine/dactinomycin/doxorubicin x25 weeks; XRT"', 'otherNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'seriousNumAffected': 1}], 'otherEvents': [{'term': '10100-Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '10200-Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '10300-Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '10700-Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '11100-Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '11300-Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '11400-Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '11600-Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '13100-Anaphylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '13200-Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '13500-Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '14100-Apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '14900-Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '15000-Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '15400-Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '17200-Blood and lymphatic system disorders - Other specif', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '17400-Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '20000-Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '20500-Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '22100-Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '22200-Colonic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '22300-Colonic hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '24100-Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '24300-Cystitis noninfective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '24700-Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 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{'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '65800-Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '65900-Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '66000-Pleural hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '66300-Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '66400-Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '71500-Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '73700-Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '78300-Sudden death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '81200-Treatment related secondary malignancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'CTCv4'}, {'term': '87900-Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '88200-Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'UH-1', 'description': 'Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.'}, {'id': 'OG001', 'title': 'Window/UH-1', 'description': 'Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.'}, {'id': 'OG002', 'title': 'UH-2', 'description': 'Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000', 'lowerLimit': '62.5', 'upperLimit': '89.6'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '67.4'}, {'value': '87.5', 'groupId': 'OG002', 'lowerLimit': '64.6', 'upperLimit': 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With Stage I-IV Malignant Rhabdoid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UH-1', 'description': 'Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphamide; x 30 weeks; XRT.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.9', 'groupId': 'OG000', 'lowerLimit': '20.1', 'upperLimit': '57.7'}]}]}], 'analyses': [{'pValue': '.3478', 'groupIds': ['OG000'], 'paramType': 'Log Rank Test Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.8814', 'groupDescription': 'The overall survival distributions of patients with Stage I-IV malignant rhabdoid tumors on AREN0321 and National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study (NCT00002610) were compared using the log-rank test.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'The outcome of these patients will be compared with a fixed outcome based on that seen for similar patients treated with NWTS-5 regimen (NCT00002610).', 'unitOfMeasure': 'Percentage of 4-year OS', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients with Stage I-IV rhabdoid tumor.'}, {'type': 'PRIMARY', 'title': 'Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Window/UH-1 and UH-2', 'description': 'Combine window/UH-1 and UH-2 for response rate monitoring for window therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '49', 'upperLimit': '92'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 months', 'description': 'Criteria for response assessed by three-dimensional measurement: Complete Response (CR), Disappearance of all index lesions and 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No new lesions; Partial Response (PR), At least a 65% decrease in the sum of the volumes of the index lesions. No new lesions; Response rate (RR) = CR+PR of patients who received window therapy.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Event Free Survival Probability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Regimen DD-4A', 'description': 'Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '100.0', 'upperLimit': '100.0'}]}]}], 'analyses': [{'pValue': '.0570', 'groupIds': ['OG000'], 'paramType': 'Log Rank Test Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.6216', 'groupDescription': 'The event-free survival distributions of patients with Stage I focal and diffuse anaplastic Wilms tumors on AREN0321 and National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study (NCT00002610) were compared using the log-rank test.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'Event-free survival will be informally compared to that seem for similar patients treated on NWTS-5 (NCT00002610).', 'unitOfMeasure': 'Percent Probability 4 Year EFS', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients with Stage I focal and diffuse anaplastic Wilms tumor.'}, {'type': 'PRIMARY', 'title': 'Toxicity Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined UH-2, UH-1, Window/UH-1', 'description': 'Combined UH-1, UH-2, and Window/UH-1 for revised-UH toxicity monitoring'}], 'classes': [{'title': 'Cardiac toxicities', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10.3'}]}]}, {'title': 'Treatment-related deaths', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10.3'}]}]}, {'title': 'Sinusoidal Obstruction Syndrome', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 years', 'description': 'Percentage of participants with Grade 4 cardiac toxicities, Grade 4 Sinusoidal Obstruction Syndrome (SOS), and treatment-related deaths determined using CTCAE v4.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients treated after Amendment 3A for arms UH-1, UH-2, and Window/UH-1.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UH-1', 'description': 'Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.'}, {'id': 'OG001', 'title': 'Window/UH-1', 'description': 'Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'unitOfMeasure': 'Count participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients with reported INI1 mutation data.'}, {'type': 'SECONDARY', 'title': 'Frequency of TP53 Mutations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'UH-1', 'description': 'Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide;x 30 weeks; XRT.'}, {'id': 'OG001', 'title': 'Window/UH-1', 'description': 'Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.'}, {'id': 'OG002', 'title': 'UH-2', 'description': 'Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT'}, {'id': 'OG003', 'title': 'Regimen DD-4A', 'description': 'Vincristine/dactinomycin/doxorubicin x25 weeks; XRT'}], 'timeFrame': 'At baseline', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was supplanted by an analysis done as part of the TARGET initiative on NWTS-5 sample as a result no TP53 data was collected on AREN0321.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Surgery', 'description': 'Surgery Only'}, {'id': 'FG001', 'title': 'UH-1', 'description': 'Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.'}, {'id': 'FG002', 'title': 'Window/UH-1', 'description': 'Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.'}, {'id': 'FG003', 'title': 'UH-2', 'description': 'Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.'}, {'id': 'FG004', 'title': 'Regimen I', 'description': 'Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT.'}, {'id': 'FG005', 'title': 'Regimen DD-4A', 'description': 'Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '78'}, {'groupId': 'FG005', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '77'}, {'groupId': 'FG005', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Refusal of further protocol therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '291', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Surgery', 'description': 'Surgery Only'}, {'id': 'BG001', 'title': 'UH-1', 'description': 'Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.'}, {'id': 'BG002', 'title': 'Window/UH-1', 'description': 'Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.'}, {'id': 'BG003', 'title': 'UH-2', 'description': 'Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.'}, {'id': 'BG004', 'title': 'Regimen I', 'description': 'Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT.'}, {'id': 'BG005', 'title': 'Regimen DD-4A', 'description': 'Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '148.53', 'spread': '51.74', 'groupId': 'BG000'}, {'value': '52.39', 'spread': '40.09', 'groupId': 'BG001'}, {'value': '68.95', 'spread': '97.64', 'groupId': 'BG002'}, {'value': '54.04', 'spread': '19.71', 'groupId': 'BG003'}, {'value': '34.10', 'spread': '31.10', 'groupId': 'BG004'}, {'value': '54.29', 'spread': '32.72', 'groupId': 'BG005'}, {'value': '70.60', 'spread': '60.50', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '137', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '154', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '253', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '60', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '202', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'lastUpdateSubmitDate': '2017-06-22', 'studyFirstSubmitDate': '2006-06-08', 'resultsFirstSubmitDate': '2016-11-28', 'studyFirstSubmitQcDate': '2006-06-08', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-12', 'studyFirstPostDateStruct': {'date': '2006-06-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)", 'timeFrame': '4 years', 'description': 'Compare the outcome of patients treated with alternating CyCE/VDCy chemotherapy (with or without vincristine/irinotecan cycles) to a fixed outcome based on that seen for similar patients treated with NWTS-5 (NCT00002610).'}, {'measure': 'Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors', 'timeFrame': '4 years', 'description': 'The outcome of these patients will be compared with a fixed outcome based on that seen for similar patients treated with NWTS-5 regimen (NCT00002610).'}, {'measure': 'Response Rate', 'timeFrame': 'Up to 2 months', 'description': 'Criteria for response assessed by three-dimensional measurement: Complete Response (CR), Disappearance of all index lesions and non-index lesions. No new lesions; Partial Response (PR), At least a 65% decrease in the sum of the volumes of the index lesions. No new lesions; Response rate (RR) = CR+PR of patients who received window therapy.'}, {'measure': 'Event Free Survival Probability', 'timeFrame': '4 years', 'description': 'Event-free survival will be informally compared to that seem for similar patients treated on NWTS-5 (NCT00002610).'}, {'measure': 'Toxicity Rate', 'timeFrame': 'Up to 4 years', 'description': 'Percentage of participants with Grade 4 cardiac toxicities, Grade 4 Sinusoidal Obstruction Syndrome (SOS), and treatment-related deaths determined using CTCAE v4.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization', 'timeFrame': 'At baseline'}, {'measure': 'Frequency of TP53 Mutations', 'timeFrame': 'At baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Childhood Renal Cell Carcinoma', 'Clear Cell Renal Cell Carcinoma', 'Clear Cell Sarcoma of the Kidney', 'Papillary Renal Cell Carcinoma', 'Rhabdoid Tumor of the Kidney', 'Stage I Renal Cell Cancer', 'Stage I Renal Wilms Tumor', 'Stage II Renal Cell Cancer', 'Stage II Renal Wilms Tumor', 'Stage III Renal Cell Cancer', 'Stage III Renal Wilms Tumor', 'Stage IV Renal Cell Cancer', 'Stage IV Renal Wilms Tumor']}, 'referencesModule': {'references': [{'pmid': '38396300', 'type': 'DERIVED', 'citation': "Benedetti DJ, Renfro LA, Tfirn I, Daw NC, Kalapurakal JA, Ehrlich PF, Khanna G, Perlman E, Warwick A, Gow KW, Paulino AC, Seibel NL, Grundy P, Fernandez CV, Geller JI, Mullen EA, Dome JS. Treatment and outcomes of clear cell sarcoma of the kidney: A report from the Children's Oncology Group studies AREN0321 and AREN03B2. Cancer. 2024 Jul 1;130(13):2361-2371. doi: 10.1002/cncr.35266. Epub 2024 Feb 23."}]}, 'descriptionModule': {'briefSummary': 'This phase II trial is studying how well combination chemotherapy, radiation therapy, and/or surgery work in treating patients with high-risk kidney tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Evaluate whether a treatment regimen containing cyclophosphamide, carboplatin, and etoposide alternating with vincristine, doxorubicin hydrochloride, and cyclophosphamide (regimen UH-1) improves the event-free and overall survival of patients with diffuse anaplastic Wilms\' tumor (DAWT) as compared to historical controls.\n\nII. Evaluate, in a phase II "window" study, the antitumor activity of a combination of vincristine and protracted-schedule irinotecan hydrochloride in patients with metastatic DAWT.\n\nIII. Evaluate whether regimen UH-1 improves the event-free and overall survival of patients with malignant rhabdoid tumor (MRT) as compared to historical controls.\n\nIV. Maintain the excellent event-free survival of patients with stage I clear cell sarcoma of the kidney (CCSK) without the use of abdominal irradiation.\n\nSECONDARY OBJECTIVES:\n\nI. Describe the outcomes of patients with stage I DAWT or stages I-III focal anaplastic Wilms\' tumor (FAWT) treated with vincristine, dactinomycin, doxorubicin hydrochloride, and flank radiation.\n\nII. Describe the outcomes of patients with stage IV FAWT or stage IV CCSK treated with regimen UH-1.\n\nIII. Describe event-free and overall survival of children and adolescents with localized renal cell carcinoma (RCC) (including patients with local lymph node involvement) treated with surgical resection without adjuvant therapy.\n\nIV. Describe response rate, event-free survival, and overall survival of patients with unresectable or distantly metastatic RCC treated according to institutional preference.\n\nV. Correlate histologic and molecular cytogenetic findings with outcome in pediatric RCC.\n\nVI. Evaluate the frequency of germline and inherited INI1 mutations in renal and extrarenal MRT and correlate the presence of detectable INI1 mutation with clinical outcome.\n\nVII. Determine the frequency of TP53 mutations in anaplastic Wilms\' tumor and correlate the presence of detectable TP53 mutation with clinical outcome.\n\nOUTLINE: This is a multicenter study. Patients are assigned to 1 of 6 treatment regimens according to tumor histology, stage of disease, and response to treatment.\n\nSURGERY (renal cell carcinoma \\[RCC\\]): Patients with completely resectable stage I-IV RCC undergo surgical resection. Patients with incompletely resectable stage III-IV RCC undergo treatment as per physician\'s choice.\n\nREGIMEN UH-1 (stage II-III or stage IV \\[with no measurable disease\\] diffuse anaplastic Wilms\' tumor \\[DAWT\\], stage I-IV malignant rhabdoid tumor \\[MRT\\], stage IV focal anaplastic Wilms\' tumor \\[FAWT\\], or stage IV clear cell sarcoma of the kidney \\[CCSK\\]): Patients receive vincristine IV on day 1 in weeks 1-3, 10-12, 13-15, 22-24, and 28-30; doxorubicin hydrochloride IV over 15 minutes on day 1 and cyclophosphamide (CPM2) IV over 15-30 minutes on day 1 in weeks 1, 10, 13, 22, and 28; and cyclophosphamide (at lower doses \\[CPM1\\]) IV over 1 hour and etoposide IV over 1 hour on days 1-4 and carboplatin IV over 1 hour on day 1 in weeks 4, 7, 16, 19, and 25. Patients whose primary tumors were initially resected undergo radiotherapy once daily 5 days a week for 4-5½ weeks beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13. Patients with unresectable CCSK receive no further study therapy.\n\nIRINOTECAN/VINCRISTINE WINDOW THERAPY\\* (stage IV DAWT with measurable disease at diagnosis): Patients receive vincristine IV on day 1 and irinotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 2. Patients with progressive disease (PD) are treated with regimen UH-1. Patients with stable disease (SD), partial response (PR), or complete response (CR) receive another course of irinotecan hydrochloride/vincristine window therapy beginning on day 22. After the second course, patients with SD or PD are treated with regimen UH-1 and patients with PR or CR are treated with regimen UH-2.\n\nNOTE: \\*Patients who are eligible for but who are unwilling to receive window therapy, receive therapy on regimen UH-1.\n\nREGIMEN UH-2 (DAWT with CR/PR to irinotecan hydrochloride/vincristine window therapy): Patients receive vincristine on day 1 in weeks 1-3, 10, 11, 16-21, 25, 26, 28-30, and 34-36 and doxorubicin hydrochloride and CPM2 as in regimen UH-1 in weeks 1, 16, 19, 28, and 34. Patients also receive CPM1, etoposide, and carboplatin as in regimen UH-1 in weeks 4, 7, 13, 22, and 31 and irinotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 10, 11, 25, and 26. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 7. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 7.\n\nREGIMEN I (stage I-III CCSK): Patients receive vincristine IV on day 1 in weeks 1-3, 5-9, 8-9, 11-14, 19, and 25; doxorubicin hydrochloride IV over 15 minutes on day 1 and cyclophosphamide IV over 1 hour on days 1-3 in weeks 1, 7, 13, 19, and 25; and cyclophosphamide IV and etoposide IV on days 1-5 in weeks 4, 10, 16, and 22. Patients whose primary tumors were initially resected (except those with stage I CCSK) undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13.\n\nREGIMEN DD-4A (stage I DAWT or stages I-III FAWT): Patients receive dactinomycin IV over 1-5 minutes on day 1 in weeks 1, 7, 13, 19, and 25; vincristine IV on day 1 in weeks 1-10, 13, 16, 19, 22, and 25; and doxorubicin hydrochloride IV over 15 minutes on day 1 in weeks 4,10, 16, and 22. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed periodically for at least 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '29 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Newly diagnosed disease of 1 of the following histologic types:\n\n * Focal anaplastic Wilms' tumor\n * Diffuse anaplastic Wilms' tumor\n * Clear cell sarcoma of the kidney\n * Malignant rhabdoid tumor (renal or extrarenal)\n * Renal cell carcinoma\n\n * Clear cell\n * Papillary\n * Renal medullary\n * Oncocytoid\n * Sarcomatoid\n * Chromophobe\n * Translocation\n * Collecting duct\n * Carcinoma associated with neuroblastoma\n * Renal cell carcinoma unclassified\n* Specimens/materials must be submitted for central review by Day 7\n* Patients must begin protocol therapy on AREN0321 by Day 14 after surgery or biopsy (surgery/biopsy is Day 0), unless medically contraindicated\n* Karnofsky performance status (PS) must be \\>= 50 for patients \\> 16 years if age and Lansky PS must be \\>= 50 for patients =\\< 16 years of age\n* Patients must not have received systemic chemotherapy or radiation therapy prior to treatment on this study UNLESS they were enrolled on the AREN0532 or AREN0533 studies and received prenephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor; additionally, patients with pediatric RCC who previously received chemotherapy for another type of malignancy (not the RCC) or non-malignant condition may enroll on the study\n* Total bilirubin =\\< 1.5 times upper limit of normal (ULN) for age\n* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\] or serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase \\[ ALT\\]) \\< 2.5 times ULN for age\n* Shortening fraction of \\>= 27% by echocardiogram OR ejection fraction of \\>= 50% by radionuclide angiogram\n* Female patients of childbearing age must have a negative pregnancy test\n* Female patients who are lactating must agree to stop breast-feeding\n* Sexually active patients of childbearing potential must agree to use effective contraception\n* All patients and/or their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met"}, 'identificationModule': {'nctId': 'NCT00335556', 'briefTitle': 'Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Treatment of High Risk Renal Tumors: A Groupwide Phase II Study', 'orgStudyIdInfo': {'id': 'AREN0321'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00414', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'COG-AREN0321', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'CDR0000472893', 'type': 'OTHER', 'domain': 'ClinicalTrials.gov'}, {'id': 'AREN0321', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'AREN0321', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgery', 'description': "Patients with completely resectable stage I-IV RCC undergo surgical resection. Patients with incompletely resectable stage III-IV RCC undergo treatment as per physician's choice.", 'interventionNames': ['Procedure: Conventional Surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment (UH-1)', 'description': 'Patients receive combination chemotherapy comprising vincristine, doxorubicin hydrochloride, cyclophosphamide, etoposide, and carboplatin. Patients whose primary tumors were initially resected undergo radiotherapy once daily 5 days a week for 4-5½ weeks beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13. Patients with unresectable clear cell sarcoma of the kidney (CCSK) receive no further study therapy.', 'interventionNames': ['Drug: Doxorubicin Hydrochloride', 'Procedure: Conventional Surgery', 'Drug: Cyclophosphamide', 'Drug: Etoposide', 'Drug: Carboplatin', 'Drug: Vincristine Sulfate', 'Radiation: Radiation Therapy', 'Other: Laboratory Biomarker Analysis']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment (window/UH-1)', 'description': 'Patients receive vincristine IV on days 1 and 8 and irinotecan hydrochloride IV over 30 minutes on days 1-5 and 8-12 (course 1). Patients with progressive disease (PD) are treated with regimen UH-1. Patients with stable disease (SD), partial response (PR), or complete response (CR) receive another course of irinotecan hydrochloride/vincristine window therapy beginning on day 22. After the second course, patients with SD or PD are treated with regimen UH-1 and patients with PR or CR are treated with regimen UH-2.', 'interventionNames': ['Drug: Doxorubicin Hydrochloride', 'Drug: Irinotecan Hydrochloride', 'Procedure: Conventional Surgery', 'Drug: Cyclophosphamide', 'Drug: Etoposide', 'Drug: Carboplatin', 'Drug: Vincristine Sulfate', 'Radiation: Radiation Therapy', 'Other: Laboratory Biomarker Analysis']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment (UH-2)', 'description': 'Patients receive combination chemotherapy comprising vincristine, doxorubicin hydrochloride, cyclophosphamide, etoposide, carboplatin, and irinotecan hydrochloride. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 7. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 7.', 'interventionNames': ['Drug: Doxorubicin Hydrochloride', 'Drug: Irinotecan Hydrochloride', 'Procedure: Conventional Surgery', 'Drug: Etoposide', 'Drug: Carboplatin', 'Drug: Vincristine Sulfate', 'Radiation: Radiation Therapy', 'Other: Laboratory Biomarker Analysis']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment (regimen I)', 'description': 'Patients receive vincristine, doxorubicin hydrochloride, cyclophosphamide, and etoposide. Patients whose primary tumors were initially resected (except those with stage I CCSK) undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13.', 'interventionNames': ['Drug: Doxorubicin Hydrochloride', 'Procedure: Conventional Surgery', 'Drug: Cyclophosphamide', 'Drug: Etoposide', 'Drug: Vincristine Sulfate', 'Radiation: Radiation Therapy', 'Other: Laboratory Biomarker Analysis']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment (regimen DD-4A)', 'description': 'Patients receive dactinomycin, vincristine, and doxorubicin hydrochloride. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13.', 'interventionNames': ['Drug: Doxorubicin Hydrochloride', 'Procedure: Conventional Surgery', 'Biological: Dactinomycin', 'Drug: Vincristine Sulfate', 'Radiation: Radiation Therapy', 'Other: Laboratory Biomarker Analysis']}], 'interventions': [{'name': 'Doxorubicin Hydrochloride', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Treatment (UH-1)', 'Treatment (UH-2)', 'Treatment (regimen DD-4A)', 'Treatment (regimen I)', 'Treatment (window/UH-1)']}, {'name': 'Irinotecan Hydrochloride', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Treatment (UH-2)', 'Treatment (window/UH-1)']}, {'name': 'Conventional Surgery', 'type': 'PROCEDURE', 'otherNames': ['surgery, conventional'], 'description': 'Patients undergo resection', 'armGroupLabels': ['Surgery', 'Treatment (UH-1)', 'Treatment (UH-2)', 'Treatment (regimen DD-4A)', 'Treatment (regimen I)', 'Treatment (window/UH-1)']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Treatment (UH-1)', 'Treatment (regimen I)', 'Treatment (window/UH-1)']}, {'name': 'Etoposide', 'type': 'DRUG', 'otherNames': ['Lastet'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (UH-1)', 'Treatment (UH-2)', 'Treatment (regimen I)', 'Treatment (window/UH-1)']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Treatment (UH-1)', 'Treatment (UH-2)', 'Treatment (window/UH-1)']}, {'name': 'Dactinomycin', 'type': 'BIOLOGICAL', 'otherNames': ['Lyovac Cosmegen'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (regimen DD-4A)']}, {'name': 'Vincristine Sulfate', 'type': 'DRUG', 'otherNames': ['Kyocristine', 'Oncovin', 'VCR', 'Vincasar'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (UH-1)', 'Treatment (UH-2)', 'Treatment (regimen DD-4A)', 'Treatment (regimen I)', 'Treatment (window/UH-1)']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Cancer Radiotherapy', 'Irradiate', 'Irradiated', 'Irradiation', 'RT'], 'description': 'Undergo radiotherapy', 'armGroupLabels': ['Treatment (UH-1)', 'Treatment (UH-2)', 'Treatment (regimen DD-4A)', 'Treatment (regimen I)', 'Treatment (window/UH-1)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (UH-1)', 'Treatment (UH-2)', 'Treatment (regimen DD-4A)', 'Treatment (regimen I)', 'Treatment (window/UH-1)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36604', 'city': 'Mobile', 'state': 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