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643

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North Central Cancer Treatment Group N0577 Arm B & C Evaluation/Treatment Form 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

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 6/8/15 6/8/15 -
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August 26, 2012

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Creative Commons BY-NC 3.0 Legacy
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    Brain and Central Nervous System Tumors NCT00887146 Treatment - North Central Cancer Treatment Group N0577 Arm B & C Evaluation/Treatment Form - 2745536v1.0

    English

    No Instruction available.

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

    Header

    Protocol Number
    Description

    ProtocolNorthCentralCancerTreatmentGroupIdentifierNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25581
    UMLS 2011AA Property
    C1518419
    Patient ID
    Description

    PatientNorthCentralCancerTreatmentGroupIdentifierNumber

    Data type

    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
    C25581
    UMLS 2011AA Property
    C1518419
    Patient Initials (L F M)
    Description

    PatientInitialsName

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25536
    UMLS 2011AA Property
    C1555582
    Institution Number
    Description

    InstitutionIdentifierNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Institution
    Description

    InstitutionName

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus ValueDomain
    C21541
    UMLS 2011AA ValueDomain
    C0018704
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Are data amended (If yes, highlight amended areas)
    Description

    DataAmendedInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus Property
    C25416
    UMLS 2011AA Property
    C1691222
    Unnamed 2
    Description

    Unnamed 2

    Current Cycle Number
    Description

    TreatmentCurrentCourseNumber

    Data type

    double

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25471
    UMLS 2011AA Property
    C0521116
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25379
    UMLS 2011AA Property
    C0750729
    Weight (kg used for this cycle, round to the nearest tenth)
    Description

    PatientWeightMeasurement

    Data type

    double

    Measurement units
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25208
    UMLS 2011AA Property
    C0043100
    Kg
    ECOG Performance Status (check one used for this cycle)
    Description

    PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ValueDomain
    C25491
    UMLS 2011AA ValueDomain
    C1512162
    NCI Thesaurus ObjectClass
    C20641
    UMLS 2011AA ObjectClass
    C1518965
    Was this cycle of treatment held (check one)
    Description

    TherapyCurrentCourseDiscontinuedIndicator

    Data type

    text

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

    TherapyCurrentCourseDiscontinuedType

    Data type

    text

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

    TherapyCurrentCourseDiscontinuedSpecify

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25471
    UMLS 2011AA Property
    C0521116
    NCI Thesaurus Property
    C25379
    UMLS 2011AA Property
    C0750729
    NCI Thesaurus Property
    C25484
    UMLS 2011AA Property
    C1444662
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ValueDomain
    C25484
    UMLS 2011AA ValueDomain
    C1444662
    Agent Dosing
    Description

    Agent Dosing

    Agent (Erlotinib)
    Description

    AgentName

    Data type

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus ValueDomain
    C1708
    UMLS 2011AA ValueDomain
    C0450442
    NCI Thesaurus ValueDomain
    C42614
    UMLS 2011AA ValueDomain
    C0027365
    Agent Start Date (this cycle mm/dd/yyyy)
    Description

    AgentBeginDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25431
    UMLS 2011AA ValueDomain
    C0439659
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    Initial Dose (day one this cycle If agent was not given this cycle, enter the dose level received on last day of treatment.)
    Description

    AgentInitialDose

    Data type

    double

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

    AgentCourseTotalDose

    Data type

    double

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS 2011AA ValueDomain
    C0439810
    NCI Thesaurus Property
    C25379
    UMLS 2011AA Property
    C0750729
    NCI Thesaurus ValueDomain
    C25488
    UMLS 2011AA ValueDomain
    C0178602
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    Were there any dose modifications or additions/omissions to protocol treatment? (Days 1-21 mg)
    Description

    DoseModificationInd

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C25256
    UMLS 2011AA ObjectClass
    C1265611
    NCI Thesaurus Property
    C25572
    NCI Thesaurus ValueDomain
    C25572
    Reason(s) Modified (If Yes, per Section 8.0. Not BSA changes)
    Description

    SingleAgentProtocolTherapyModifiedReason

    Data type

    text

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

    SingleAgentProtocolTherapyModifiedSpecify

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus ObjectClass
    C48440
    UMLS 2011AA ObjectClass
    C0205171
    NCI Thesaurus Property
    C15368
    NCI Thesaurus Property
    C42651
    UMLS 2011AA Property
    C0442711
    NCI Thesaurus Property
    C25573
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
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    1 forms
    1. StudyEvent: North Central Cancer Treatment Group N0577 Arm B & C Evaluation/Treatment Form
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header
    ProtocolNorthCentralCancerTreatmentGroupIdentifierNumber
    Item
    Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25581 (NCI Thesaurus Property)
    C1518419 (UMLS 2011AA Property)
    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)
    C1518419 (UMLS 2011AA Property)
    PatientInitialsName
    Item
    Patient Initials (L F M)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25536 (NCI Thesaurus Property)
    C1555582 (UMLS 2011AA Property)
    InstitutionIdentifierNumber
    Item
    Institution Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    InstitutionName
    Item
    Institution
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C21541 (NCI Thesaurus ValueDomain)
    C0018704 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    Item
    Are data amended (If yes, highlight amended areas)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C25416 (NCI Thesaurus Property)
    C1691222 (UMLS 2011AA Property)
    CL.1
    Code List
    Are data amended (If yes, highlight amended areas)
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Unnamed 2
    TreatmentCurrentCourseNumber
    Item
    Current Cycle Number
    double
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25471 (NCI Thesaurus Property)
    C0521116 (UMLS 2011AA Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property)
    C0750729 (UMLS 2011AA Property)
    PatientWeightMeasurement
    Item
    Weight (kg used for this cycle, round to the nearest tenth)
    double
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25208 (NCI Thesaurus Property)
    C0043100 (UMLS 2011AA Property)
    Item
    ECOG Performance Status (check one used for this cycle)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus ValueDomain)
    C1512162 (UMLS 2011AA ValueDomain)
    C20641 (NCI Thesaurus ObjectClass)
    C1518965 (UMLS 2011AA 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)
    C0750729 (UMLS 2011AA Property)
    C25484 (NCI Thesaurus Property)
    C1444662 (UMLS 2011AA Property)
    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)
    C0750729 (UMLS 2011AA Property)
    C25484 (NCI Thesaurus Property)
    C1444662 (UMLS 2011AA Property)
    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)
    C0750729 (UMLS 2011AA Property)
    C25484 (NCI Thesaurus Property)
    C1444662 (UMLS 2011AA Property)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C25484 (NCI Thesaurus ValueDomain)
    C1444662 (UMLS 2011AA ValueDomain)
    Item Group
    Agent Dosing
    AgentName
    Item
    Agent (Erlotinib)
    text
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C0450442 (UMLS 2011AA ValueDomain)
    C42614 (NCI Thesaurus ValueDomain)
    C0027365 (UMLS 2011AA ValueDomain)
    AgentBeginDate
    Item
    Agent Start Date (this cycle mm/dd/yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25431 (NCI Thesaurus ValueDomain)
    C0439659 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA 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.)
    double
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25536 (NCI Thesaurus Property)
    C1555582 (UMLS 2011AA Property)
    C25256 (NCI Thesaurus Property)
    C1265611 (UMLS 2011AA Property)
    C25488 (NCI Thesaurus ValueDomain)
    C0178602 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ValueDomain)
    C0450442 (UMLS 2011AA ValueDomain)
    AgentCourseTotalDose
    Item
    Total Dose of Agents/Drugs for this Cycle (If agent was not given this cycle, enter 0 for dose level.)
    double
    C25304 (NCI Thesaurus ValueDomain)
    C0439810 (UMLS 2011AA ValueDomain)
    C25379 (NCI Thesaurus Property)
    C0750729 (UMLS 2011AA Property)
    C25488 (NCI Thesaurus ValueDomain)
    C0178602 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    Item
    Were there any dose modifications or additions/omissions to protocol treatment? (Days 1-21 mg)
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C25256 (NCI Thesaurus ObjectClass)
    C1265611 (UMLS 2011AA ObjectClass)
    C25572 (NCI Thesaurus Property)
    C25572 (NCI Thesaurus ValueDomain)
    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)
    C0205171 (UMLS 2011AA ObjectClass)
    C15368 (NCI Thesaurus Property)
    C42651 (NCI Thesaurus Property)
    C0442711 (UMLS 2011AA Property)
    C25573 (NCI Thesaurus Property)
    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)
    C0205171 (UMLS 2011AA ObjectClass)
    C15368 (NCI Thesaurus Property)
    C42651 (NCI Thesaurus Property)
    C0442711 (UMLS 2011AA Property)
    C25573 (NCI Thesaurus Property)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
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