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It outlines eligibility and exclusion criteria, registration and patient enrollment procedures, and detailed biomarker/correlative research logistics such as specimen collection, shipping, and tracking. 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of Hope Comprehensive Cancer Center LAO\nPrincipal Investigator:\tStephanie Yoon, M.D.\nCity of Hope Cancer Center\nDepartment of Radiation Oncology\n1500 E Duarte Road\nDuarte, CA, 91010, USA\nPhone:  626-218-2276\nFax:  626-218-5334\n\u0013 HYPERLINK \"mailto:styoon@coh.org\" \u0014styoon@coh.org\u0015\nTranslational PI:\tTerence Williams, M.D., Ph.D.\nCity of Hope Cancer Center\nDepartment of Radiation Oncology\n1500 E Duarte Road\nDuarte, CA, 91010, USA\nPhone:  626-218-2276\nFax:  626-218-5334\n\u0013 HYPERLINK \"mailto:terwilliams@coh.org\" \u0014terwilliams@coh.org\u0015\nParticipating Organizations\nStatistician:\t\t\tStudy Coordinator:\nJoycelynne Palmer, Ph.D.\t\tStella Khoo, MBA\nDivision of Biostatistics\tCity of Hope\n1500 E Duarte Road\t1500 E. Duarte Road\nDuarte, CA, USA, 91010\tDuarte, CA, USA 91010\n626-218-5266\t\t626-218-0094\n\u0013 HYPERLINK \"mailto:jmpalmer@coh.org\" \u0014jmpalmer@coh.org\u0015 \t\t\u0013 HYPERLINK \"mailto:ccc@coh.org\" \u0014ccc@coh.org\u0015\nNCI-Supplied Agent:  Triapine (NSC 663249)\nIND #:  TBD\nIND Sponsor:  NCI DCTD\nProtocol Type / Version # / Version Date:\tOriginal / September 20, 2024\n\u000f\nSCHEMA\n\u000fTABLE OF CONTENTS\n\u0013 TOC \\o \"1-2\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc176419885\" \u0014SCHEMA\t\u0013 PAGEREF _Toc176419885 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419886\" \u00141.\tOBJECTIVES\t\u0013 PAGEREF _Toc176419886 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419887\" \u00141.1\tPrimary Objectives\t\u0013 PAGEREF _Toc176419887 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419888\" \u00141.2\tSecondary Objectives\t\u0013 PAGEREF _Toc176419888 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419889\" \u00142.\tBACKGROUND\t\u0013 PAGEREF _Toc176419889 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419890\" \u00142.1\tStudy Disease(s)\t\u0013 PAGEREF _Toc176419890 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419891\" \u00142.2\tCTEP IND Agent (Triapine)\t\u0013 PAGEREF _Toc176419891 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419892\" \u00142.3\tRationale\t\u0013 PAGEREF _Toc176419892 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419893\" \u00142.4\tCorrelative Studies Background\t\u0013 PAGEREF _Toc176419893 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419894\" \u00143.\tPATIENT SELECTION\t\u0013 PAGEREF _Toc176419894 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419895\" \u00143.1\tEligibility Criteria\t\u0013 PAGEREF _Toc176419895 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419896\" \u00143.2\tExclusion Criteria\t\u0013 PAGEREF _Toc176419896 \\h \u001419\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419897\" \u00143.3\tInclusion of Women and Minorities\t\u0013 PAGEREF _Toc176419897 \\h \u001420\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419898\" \u00144.\tREGISTRATION PROCEDURES\t\u0013 PAGEREF _Toc176419898 \\h \u001420\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419899\" \u00144.1\tInvestigator and Research Associate Registration with CTEP\t\u0013 PAGEREF _Toc176419899 \\h \u001420\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419900\" \u00144.2\tSite Registration\t\u0013 PAGEREF _Toc176419900 \\h \u001421\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419901\" \u00144.3\tPatient Registration\t\u0013 PAGEREF _Toc176419901 \\h \u001424\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419902\" \u00144.4\tGeneral Guidelines\t\u0013 PAGEREF _Toc176419902 \\h \u001426\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419903\" \u00145.\tBIOMARKER, CORRELATIVE, AND SPECIAL STUDIES\t\u0013 PAGEREF _Toc176419903 \\h \u001427\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419904\" \u00145.1\tSummary Table for Specimen Collection\t\u0013 PAGEREF _Toc176419904 \\h \u001427\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419905\" \u00145.2\tSummary Table(s) for Interventional Radiologist for Research Biopsies\t\u0013 PAGEREF _Toc176419905 \\h \u001428\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419906\" \u00145.3\tSpecimen Procurement Kits and Scheduling\t\u0013 PAGEREF _Toc176419906 \\h \u001428\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419907\" \u00145.4\tSpecimen Tracking System Instructions\t\u0013 PAGEREF _Toc176419907 \\h \u001429\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419908\" \u00145.5\tSpecimen Collection\t\u0013 PAGEREF _Toc176419908 \\h \u001434\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419909\" \u00145.6\tShipping Specimens from Clinical Site to the EET Biobank\t\u0013 PAGEREF _Toc176419909 \\h \u001437\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419910\" \u00145.7\tShipping of Specimens from Clinical Site to Other Laboratories\t\u0013 PAGEREF _Toc176419910 \\h \u001439\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419911\" \u00145.8\tBiomarker Plan\t\u0013 PAGEREF _Toc176419911 \\h \u001440\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc176419912\" \u00145.9\tIntegrated Correlative St","cbCaipTBdTqYBPDM","https://ap.wps.com/l/cbCaipTBdTqYBPDM","docx",968255,6,103,"English","# OBJECTIVES\n## Primary Objectives\n## Secondary Objectives\n# BACKGROUND\n## Study Disease(s)\n## CTEP IND Agent (Triapine)\n# PATIENT SELECTION\n## Eligibility Criteria\n## Exclusion Criteria","[{\"question\":\"What is the study’s main purpose in this SCHEMA protocol?\",\"answer\":\"The protocol evaluates a Phase I combination of Triapine with radiation therapy for recurrent glioblastoma, with primary and secondary objectives to define clinical outcomes and related measures.\"},{\"question\":\"Who are the key roles and participating organizations listed in the protocol?\",\"answer\":\"The protocol identifies principal and translational investigators at City of Hope Comprehensive Cancer Center and lists participating organization roles including study coordinator and statistician.\"},{\"question\":\"What sections describe patient eligibility and study workflow?\",\"answer\":\"Patient selection includes eligibility and exclusion criteria, and registration procedures cover investigator/site registration and patient registration steps.\"}]","A Phase I Trial Combining Triapine with Radiation Therapy for Recurrent Glioblastoma - SCHEMA | DOCX",1788088565,36]