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2466

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ACOSOG-Z4099 End of Intervention Form Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9869A599-BCAB-139E-E040-BB89AD432862

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9869A599-BCAB-139E-E040-BB89AD432862

Keywords

  1. 9/19/12 9/19/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
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September 19, 2012

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Creative Commons BY-NC 3.0 Legacy

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    Lung Cancer NCT01336894 Off Treatment - ACOSOG-Z4099 End of Intervention Form - 3178441v1.0

    ALL ITEMS MUST BE COMPLETED

    1. StudyEvent: ACOSOG-Z4099 End of Intervention Form
      1. ALL ITEMS MUST BE COMPLETED
    Header Module
    Description

    Header Module

    Protocol Number
    Description

    ProtocolACOSOGIdentifierNumber

    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
    C19712
    UMLS 2011AA Property
    C1515944
    Patient ID
    Description

    PatientCoordinatingIdentifierNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25462
    UMLS 2011AA Property
    C0700114
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    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 (check one if data amended, please circle in red when using paper forms)
    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
    Preregistration Screening Failure
    Description

    Preregistration Screening Failure

    Last Date (any modality of) protocol therapy was given (dd MMM yyyy date of surgery or last SBRT fraction on this study or date decision made not to initiate protocol treatment)
    Description

    TreatmentEndDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    NCI Thesaurus Property
    C25496
    UMLS 2011AA Property
    C2746065
    Off Treatment Date (dd MMM yyyy date decision was made to end active treatment or not to initiate protocol treatment)
    Description

    OffTreatmentDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25601
    UMLS 2011AA ObjectClass
    C1518544
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    Reason Treatment Ended (Intervention check one)
    Description

    Off-treatmentReason

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS 2011AA ValueDomain
    C0392360
    NCI Thesaurus ObjectClass
    C25601
    UMLS 2011AA ObjectClass
    C1518544
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Patient withdrawal/refusal after beginning protocol therapy specify
    Description

    PatientBeginProtocolTherapyRefuseSpecify

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25320
    UMLS 2011AA Property
    C1507394
    NCI Thesaurus Property
    C49161
    UMLS 2011AA Property
    C1705116
    NCI Thesaurus Property
    C15368
    NCI Thesaurus Property
    C25431
    UMLS 2011AA Property
    C0439659
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Patient withdrawal/refusal prior to beginning protocol therapy specify
    Description

    PatientPriorProtocolTherapyRefuseSpecify

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25320
    UMLS 2011AA Property
    C1507394
    NCI Thesaurus Property
    C49161
    UMLS 2011AA Property
    C1705116
    NCI Thesaurus Property
    C25629
    UMLS 2011AA Property
    C0332152
    NCI Thesaurus Property
    C15368
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Adverse event/side effects/complications specify
    Description

    Off-TreatmentAdverseEventReasonSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus Property
    C25638
    UMLS 2011AA Property
    C0392360
    NCI Thesaurus Property
    C41331
    UMLS 2011AA Property
    C0877248
    NCI Thesaurus ObjectClass
    C25601
    UMLS 2011AA ObjectClass
    C1518544
    Alternative Therapy, specify
    Description

    Off-treatmentAlternativeReasonSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C25601
    UMLS 2011AA ObjectClass
    C1518544
    NCI Thesaurus Property
    C25415
    UMLS 2011AA Property
    C1523987
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Patient off-treatment for other complicating disease, Specify
    Description

    Off-treatmentComplicatingReasonSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C25601
    UMLS 2011AA ObjectClass
    C1518544
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    NCI Thesaurus Property
    C25455
    UMLS 2011AA Property
    C1522701
    Other specify
    Description

    Off-treatmentReasonSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C25601
    UMLS 2011AA ObjectClass
    C1518544
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257

    Similar models

    ALL ITEMS MUST BE COMPLETED

    1. StudyEvent: ACOSOG-Z4099 End of Intervention Form
      1. ALL ITEMS MUST BE COMPLETED
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header Module
    ProtocolACOSOGIdentifierNumber
    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)
    C19712 (NCI Thesaurus Property)
    C1515944 (UMLS 2011AA Property)
    PatientCoordinatingIdentifierNumber
    Item
    Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25462 (NCI Thesaurus Property)
    C0700114 (UMLS 2011AA Property)
    C25364 (NCI Thesaurus Property)
    C0600091 (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 (check one if data amended, please circle in red when using paper forms)
    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)
    Code List
    Are data amended (check one if data amended, please circle in red when using paper forms)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item Group
    Preregistration Screening Failure
    TreatmentEndDate
    Item
    Last Date (any modality of) protocol therapy was given (dd MMM yyyy date of surgery or last SBRT fraction on this study or date decision made not to initiate protocol treatment)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    C25496 (NCI Thesaurus Property)
    C2746065 (UMLS 2011AA Property)
    OffTreatmentDate
    Item
    Off Treatment Date (dd MMM yyyy date decision was made to end active treatment or not to initiate protocol treatment)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    Item
    Reason Treatment Ended (Intervention check one)
    text
    C25638 (NCI Thesaurus ValueDomain)
    C0392360 (UMLS 2011AA ValueDomain)
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Code List
    Reason Treatment Ended (Intervention check one)
    CL Item
    Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
    CL Item
    Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
    CL Item
    Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
    CL Item
    Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
    CL Item
    Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
    CL Item
    Disease Progression Before Active Treatment (Disease Progression before active treatment)
    CL Item
    Alternative Therapy (Alternative therapy)
    CL Item
    Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
    CL Item
    Death On Study (Death on study)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    PatientBeginProtocolTherapyRefuseSpecify
    Item
    Patient withdrawal/refusal after beginning protocol therapy specify
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25320 (NCI Thesaurus Property)
    C1507394 (UMLS 2011AA Property)
    C49161 (NCI Thesaurus Property)
    C1705116 (UMLS 2011AA Property)
    C15368 (NCI Thesaurus Property)
    C25431 (NCI Thesaurus Property)
    C0439659 (UMLS 2011AA Property)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    PatientPriorProtocolTherapyRefuseSpecify
    Item
    Patient withdrawal/refusal prior to beginning protocol therapy specify
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25320 (NCI Thesaurus Property)
    C1507394 (UMLS 2011AA Property)
    C49161 (NCI Thesaurus Property)
    C1705116 (UMLS 2011AA Property)
    C25629 (NCI Thesaurus Property)
    C0332152 (UMLS 2011AA Property)
    C15368 (NCI Thesaurus Property)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    Off-TreatmentAdverseEventReasonSpecify
    Item
    Adverse event/side effects/complications specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C25638 (NCI Thesaurus Property)
    C0392360 (UMLS 2011AA Property)
    C41331 (NCI Thesaurus Property)
    C0877248 (UMLS 2011AA Property)
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS 2011AA ObjectClass)
    Off-treatmentAlternativeReasonSpecify
    Item
    Alternative Therapy, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS 2011AA ObjectClass)
    C25415 (NCI Thesaurus Property)
    C1523987 (UMLS 2011AA Property)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Off-treatmentComplicatingReasonSpecify
    Item
    Patient off-treatment for other complicating disease, Specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    C25455 (NCI Thesaurus Property)
    C1522701 (UMLS 2011AA Property)
    Off-treatmentReasonSpecify
    Item
    Other specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)

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