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10799

Descrição

North Central Cancer Treatment Group N0577 Arm B & C Evaluation/Treatment Form NCT00887146 Radiation Therapy or Radiation Therapy and Temozolomide or Temozolomide Alone in Treating Patients With Newly Diagnosed Anaplastic Glioma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4C094A66-1244-40DD-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4C094A66-1244-40DD-E044-0003BA3F9857

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Versões (3)
  1. 26/8/12 26/8/12 -
  2. 8/1/15 8/1/15 - Martin Dugas
  3. 8/6/15 8/6/15 -
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8 de junio de 2015

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Creative Commons BY-NC 3.0 Legacy
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    North Central Cancer Treatment Group N0577 Arm B & C Evaluation/Treatment Form NCT00887146

    Inglês

    No Instruction available.

    1 Formulários  
    1. StudyEvent: North Central Cancer Treatment Group N0577 Arm B & C Evaluation/Treatment Form
      1. No Instruction available.
    Header
    Descrição

    Header

    Protocol Number
    Descrição

    Protocol ID NCCTG

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1518419
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25581
    Patient ID
    Descrição

    PatientNorthCentralCancerTreatmentGroupIdentifierNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property-2
    C25581
    UMLS 2011AA Property-2
    C1518419
    Patient Initials (L F M)
    Descrição

    Patient Initials

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Institution Number
    Descrição

    Institution Number

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    UMLS CUI-2
    C0805701
    NCI Thesaurus Property
    C25364
    Institution
    Descrição

    Institution Name

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ValueDomain-2
    C21541
    NCI Thesaurus Property
    C25364
    Are data amended (If yes, highlight amended areas)
    Descrição

    Data amended

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Assessment of Chemotherapy
    Descrição

    Assessment of Chemotherapy

    Current Cycle Number
    Descrição

    Cycle Number Chemotherapeutics

    Tipo de dados

    integer

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2045829
    NCI Thesaurus Property
    C25471
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property-2
    C25379
    Weight (kg used for this cycle, round to the nearest tenth)
    Descrição

    Patient Weight

    Tipo de dados

    float

    Unidades de medida
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005910
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    Kg
    ECOG Performance Status (check one used for this cycle)
    Descrição

    ECOG Performance Status

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1520224
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ValueDomain-2
    C25491
    NCI Thesaurus ObjectClass
    C20641
    Was this cycle of treatment held (check one)
    Descrição

    TherapyCurrentCourseDiscontinuedIndicator

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25471
    UMLS 2011AA Property
    C0521116
    NCI Thesaurus Property-2
    C25379
    UMLS 2011AA Property-2
    C0750729
    NCI Thesaurus Property-3
    C25484
    UMLS 2011AA Property-3
    C1444662
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    Primary reason treatment held (If yes, planned or unplanned)
    Descrição

    TherapyCurrentCourseDiscontinuedType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25471
    UMLS 2011AA Property
    C0521116
    NCI Thesaurus Property-2
    C25379
    UMLS 2011AA Property-2
    C0750729
    NCI Thesaurus Property-3
    C25484
    UMLS 2011AA Property-3
    C1444662
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Other, specify (not per protocol)
    Descrição

    TherapyCurrentCourseDiscontinuedSpecify

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25471
    UMLS 2011AA Property
    C0521116
    NCI Thesaurus Property-2
    C25379
    UMLS 2011AA Property-2
    C0750729
    NCI Thesaurus Property-3
    C25484
    UMLS 2011AA Property-3
    C1444662
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ValueDomain-2
    C25484
    UMLS 2011AA ValueDomain-2
    C1444662
    Agent (Erlotinib)
    Descrição

    Agent

    Tipo de dados

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS CUI-1
    C1521826
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain
    C1708
    NCI Thesaurus ValueDomain-2
    C42614
    Agent Start Date (this cycle mm/dd/yyyy)
    Descrição

    Concomitant Medication Start Date

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2826734
    NCI Thesaurus ValueDomain-2
    C25431
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property
    C25275
    Initial Dose (day one this cycle If agent was not given this cycle, enter the dose level received on last day of treatment.)
    Descrição

    AgentInitialDose

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25536
    UMLS 2011AA Property
    C1555582
    NCI Thesaurus Property-2
    C25256
    UMLS 2011AA Property-2
    C1265611
    NCI Thesaurus ValueDomain
    C25488
    UMLS 2011AA ValueDomain
    C0178602
    NCI Thesaurus ValueDomain-2
    C1708
    UMLS 2011AA ValueDomain-2
    C0450442
    Total Dose of Agents/Drugs for this Cycle (If agent was not given this cycle, enter 0 for dose level.)
    Descrição

    Agent Total Dose

    Tipo de dados

    float

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS CUI-1
    C2986497
    NCI Thesaurus Property
    C25379
    NCI Thesaurus ValueDomain-2
    C25488
    NCI Thesaurus ObjectClass
    C1708
    Were there any dose modifications or additions/omissions to protocol treatment? (Days 1-21 mg)
    Descrição

    Dose Modification

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25256
    NCI Thesaurus Property
    C25572
    NCI Thesaurus ValueDomain-2
    C25572
    Reason(s) Modified (If Yes, per Section 8.0. Not BSA changes)
    Descrição

    SingleAgentProtocolTherapyModifiedReason

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus ObjectClass-2
    C48440
    UMLS 2011AA ObjectClass-2
    C0205171
    NCI Thesaurus Property
    C15368
    NCI Thesaurus Property-2
    C42651
    UMLS 2011AA Property
    C0442711
    NCI Thesaurus Property-3
    C25573
    NCI Thesaurus ValueDomain
    C25638
    UMLS 2011AA ValueDomain
    C0392360
    Other specify (not per protocol)
    Descrição

    SingleAgentProtocolTherapyModifiedSpecify

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus ObjectClass-2
    C48440
    UMLS 2011AA ObjectClass-2
    C0205171
    NCI Thesaurus Property
    C15368
    NCI Thesaurus Property-2
    C42651
    UMLS 2011AA Property
    C0442711
    NCI Thesaurus Property-3
    C25573
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
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    Similar models

    No Instruction available.

    1 Formulários
    1. StudyEvent: North Central Cancer Treatment Group N0577 Arm B & C Evaluation/Treatment Form
      1. No Instruction available.
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Header
    Protocol ID NCCTG
    Item
    Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1518419 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25581 (NCI Thesaurus Property-2)
    PatientNorthCentralCancerTreatmentGroupIdentifierNumber
    Item
    Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25581 (NCI Thesaurus Property-2)
    C1518419 (UMLS 2011AA Property-2)
    Patient Initials
    Item
    Patient Initials (L F M)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Institution Number
    Item
    Institution Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C0805701 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    Institution Name
    Item
    Institution
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C21541 (NCI Thesaurus ValueDomain-2)
    C25364 (NCI Thesaurus Property)
    Data amended
    Item
    Are data amended (If yes, highlight amended areas)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Item Group
    Assessment of Chemotherapy
    Cycle Number Chemotherapeutics
    Item
    Current Cycle Number
    integer
    C25337 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C25471 (NCI Thesaurus Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property-2)
    Patient Weight
    Item
    Weight (kg used for this cycle, round to the nearest tenth)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    Item
    ECOG Performance Status (check one used for this cycle)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1520224 (UMLS CUI-1)
    C25367 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus ValueDomain-2)
    C20641 (NCI Thesaurus ObjectClass)
    CL.2
    Code List
    ECOG Performance Status (check one used for this cycle)
    CL Item
    Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
    CL Item
    Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
    CL Item
    Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
    CL Item
    Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
    CL Item
    Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
    Item
    Was this cycle of treatment held (check one)
    text
    C15368 (NCI Thesaurus ObjectClass)
    C25471 (NCI Thesaurus Property)
    C0521116 (UMLS 2011AA Property)
    C25379 (NCI Thesaurus Property-2)
    C0750729 (UMLS 2011AA Property-2)
    C25484 (NCI Thesaurus Property-3)
    C1444662 (UMLS 2011AA Property-3)
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    CL.3
    Code List
    Was this cycle of treatment held (check one)
    CL Item
    Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
    Item
    Primary reason treatment held (If yes, planned or unplanned)
    text
    C15368 (NCI Thesaurus ObjectClass)
    C25471 (NCI Thesaurus Property)
    C0521116 (UMLS 2011AA Property)
    C25379 (NCI Thesaurus Property-2)
    C0750729 (UMLS 2011AA Property-2)
    C25484 (NCI Thesaurus Property-3)
    C1444662 (UMLS 2011AA Property-3)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.4
    Code List
    Primary reason treatment held (If yes, planned or unplanned)
    CL Item
    Hematologic (Hematologic)
    C0205488 (NCI Metathesaurus)
    CL Item
    Other Nonhematologic Adverse Events (Other nonhematologic adverse events)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    TherapyCurrentCourseDiscontinuedSpecify
    Item
    Other, specify (not per protocol)
    text
    C15368 (NCI Thesaurus ObjectClass)
    C25471 (NCI Thesaurus Property)
    C0521116 (UMLS 2011AA Property)
    C25379 (NCI Thesaurus Property-2)
    C0750729 (UMLS 2011AA Property-2)
    C25484 (NCI Thesaurus Property-3)
    C1444662 (UMLS 2011AA Property-3)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C25484 (NCI Thesaurus ValueDomain-2)
    C1444662 (UMLS 2011AA ValueDomain-2)
    Agent
    Item
    Agent (Erlotinib)
    text
    C25364 (NCI Thesaurus Property)
    C1521826 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C42614 (NCI Thesaurus ValueDomain-2)
    Concomitant Medication Start Date
    Item
    Agent Start Date (this cycle mm/dd/yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2826734 (UMLS CUI-1)
    C25431 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    C25275 (NCI Thesaurus Property)
    AgentInitialDose
    Item
    Initial Dose (day one this cycle If agent was not given this cycle, enter the dose level received on last day of treatment.)
    float
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25536 (NCI Thesaurus Property)
    C1555582 (UMLS 2011AA Property)
    C25256 (NCI Thesaurus Property-2)
    C1265611 (UMLS 2011AA Property-2)
    C25488 (NCI Thesaurus ValueDomain)
    C0178602 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ValueDomain-2)
    C0450442 (UMLS 2011AA ValueDomain-2)
    Agent Total Dose
    Item
    Total Dose of Agents/Drugs for this Cycle (If agent was not given this cycle, enter 0 for dose level.)
    float
    C25304 (NCI Thesaurus ValueDomain)
    C2986497 (UMLS CUI-1)
    C25379 (NCI Thesaurus Property)
    C25488 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    Item
    Were there any dose modifications or additions/omissions to protocol treatment? (Days 1-21 mg)
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25256 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    C25572 (NCI Thesaurus ValueDomain-2)
    CL.5
    Code List
    Were there any dose modifications or additions/omissions to protocol treatment? (Days 1-21 mg)
    CL Item
    Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
    CL Item
    Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item
    Reason(s) Modified (If Yes, per Section 8.0. Not BSA changes)
    text
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C48440 (NCI Thesaurus ObjectClass-2)
    C0205171 (UMLS 2011AA ObjectClass-2)
    C15368 (NCI Thesaurus Property)
    C42651 (NCI Thesaurus Property-2)
    C0442711 (UMLS 2011AA Property)
    C25573 (NCI Thesaurus Property-3)
    C25638 (NCI Thesaurus ValueDomain)
    C0392360 (UMLS 2011AA ValueDomain)
    CL.6
    Code List
    Reason(s) Modified (If Yes, per Section 8.0. Not BSA changes)
    CL Item
    Hematologic (Hematologic)
    C0205488 (NCI Metathesaurus)
    CL Item
    Other Nonhematologic Adverse Events (Other nonhematologic adverse events)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Increased Per Protocol (Increased per protocol)
    SingleAgentProtocolTherapyModifiedSpecify
    Item
    Other specify (not per protocol)
    text
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C48440 (NCI Thesaurus ObjectClass-2)
    C0205171 (UMLS 2011AA ObjectClass-2)
    C15368 (NCI Thesaurus Property)
    C42651 (NCI Thesaurus Property-2)
    C0442711 (UMLS 2011AA Property)
    C25573 (NCI Thesaurus Property-3)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
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