0 Ratings
ID

8296

Description

RTOG 0825 Phase III GBM Salvage Treatment Guideline Questionnaire (SX) Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5AE28686-9246-64D7-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5AE28686-9246-64D7-E044-0003BA3F9857

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Brain and Central Nervous System Tumors NCT00884741 Treatment - RTOG 0825 Phase III GBM Salvage Treatment Guideline Questionnaire (SX) - 2797409v1.0

    English

    No Instruction available.

    1 forms  
    1. StudyEvent: RTOG 0825 Phase III GBM Salvage Treatment Guideline Questionnaire (SX)
      1. No Instruction available.
    Module 1
    Description

    Module 1

    RTOG Study No.
    Description

    Protocol ID RTOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1514695
    NCI Thesaurus Property
    C19778
    NCI Thesaurus Property-2
    C25364
    Case #
    Description

    RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C19778
    UMLS 2011AA ObjectClass-2
    C1514695
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property-2
    C49152
    UMLS 2011AA Property-2
    C1706256
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    Institution Name
    Description

    Institution Name

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ValueDomain-2
    C21541
    NCI Thesaurus Property
    C25364
    Institution No.
    Description

    Institution Number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    UMLS CUI-2
    C0805701
    NCI Thesaurus Property
    C25364
    Patient Initials
    Description

    Patient Initials

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    RTOG Patient ID
    Description

    Trial subject ID RTOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1514695
    NCI Thesaurus Property
    C19778
    NCI Thesaurus Property-2
    C25364
    Amended Data (INSTRUCTIONS: Complete form on web to unblind the protocol treatment arm)
    Description

    Data amended

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Inclusion Criteria
    Description

    Inclusion Criteria

    Inclusion Criteria
    Description

    RadiationTherapyOncologyGroupPatientInclusionClinicalTrialEligibilityCriteria0825Type

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C19778
    UMLS 2011AA ObjectClass-2
    C1514695
    NCI Thesaurus Property
    C16112
    UMLS 2011AA Property
    C1516637
    NCI Thesaurus Property-2
    C25532
    UMLS 2011AA Property-2
    C1512693
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Performance Status (Karnofsky)
    Description

    KarnofskyPerformanceStatusScore

    Data type

    text

    Alias
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ObjectClass
    C20641
    UMLS 2011AA ObjectClass
    C1518965
    NCI Thesaurus ValueDomain
    C25338
    UMLS 2011AA ValueDomain
    C0449820
    Negative serum pregnancy test
    Description

    PatientNegativePregnancyTestInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25247
    UMLS 2011AA Property
    C0205160
    NCI Metathesaurus Property
    C0032976
    Planned start date for salvage treatment
    Description

    SalvageTherapyAdministeredDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C15359
    UMLS 2011AA ObjectClass
    C0085405
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Footer Module
    Description

    Footer Module

    Investigator Signature
    Description

    Investigator Signature

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    NCI Thesaurus ObjectClass
    C17089
    Date (MM DD YYYY)
    Description

    Investigator Signature Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    UMLS CUI-2
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C17089
    Back to the top of the page

    Similar models

    No Instruction available.

    1 forms
    1. StudyEvent: RTOG 0825 Phase III GBM Salvage Treatment Guideline Questionnaire (SX)
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Module 1
    Protocol ID RTOG
    Item
    RTOG Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1514695 (UMLS CUI-2)
    C19778 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    RadiationTherapyOncologyGroupPatientCaseIdentifierNumber
    Item
    Case #
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C19778 (NCI Thesaurus ObjectClass-2)
    C1514695 (UMLS 2011AA ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C49152 (NCI Thesaurus Property-2)
    C1706256 (UMLS 2011AA Property-2)
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    Institution Name
    Item
    Institution Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C21541 (NCI Thesaurus ValueDomain-2)
    C25364 (NCI Thesaurus Property)
    Institution Number
    Item
    Institution No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C0805701 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    Patient Initials
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Trial subject ID RTOG
    Item
    RTOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1514695 (UMLS CUI-2)
    C19778 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Data amended
    Item
    Amended Data (INSTRUCTIONS: Complete form on web to unblind the protocol treatment arm)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Item Group
    Inclusion Criteria
    Item
    Inclusion Criteria
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C19778 (NCI Thesaurus ObjectClass-2)
    C1514695 (UMLS 2011AA ObjectClass-2)
    C16112 (NCI Thesaurus Property)
    C1516637 (UMLS 2011AA Property)
    C25532 (NCI Thesaurus Property-2)
    C1512693 (UMLS 2011AA Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.2
    Code List
    Inclusion Criteria
    CL Item
    For Females Of Childbearing Potential Was A Negative Serum Pregnancy Test Done (For females of childbearing potential was a negative serum pregnancy test done)
    CL Item
    Has The Patient Received Any Chemotherapy, Radiotherapy, Or Other Treatment Intended As An Anti-cancer Therapy Since The Protocol Based Treatment (rt, Temozolomide +/- Bevacizumab/placebo) On The Blinded Component Of The Study (Has the patient received any chemotherapy, radiotherapy, or other treatment intended as an anti-cancer therapy since the protocol based treatment (RT, temozolomide +/- bevacizumab/placebo) on the blinded component of the study)
    CL Item
    Has The Patient Recovered From The Effects Of Surgery, Postoperative Infection, And Other Complications (Has the patient recovered from the effects of surgery, postoperative infection, and other complications)
    CL Item
    Has The Patient Undergone Resection Of The Recurrent Tumor/tumors (Has the patient undergone resection of the recurrent tumor/tumors)
    CL Item
    If On Full Dose Anticoagulants, Have Both Of The Following Criteria Been Met No Active Bleeding Or Pathological Condition That Carries A High Risk Of Bleeding; In-range Inr On A Stable Dose Of Oral Anticoagulant (If on full dose anticoagulants, have both of the following criteria been met No active bleeding or pathological condition that carries a high risk of bleeding; In-range INR on a stable dose of oral anticoagulant)
    CL Item
    Is Systolic Blood Pressure <=160 Mg Hg Or Diastolic Pressure <= 90 Mg Hg (Is systolic blood pressure <=160 mg hg or diastolic pressure <= 90 mg hg)
    CL Item
    Is The Electrocardiogram Without Evidence Of Acute Cardiac Ischemia (Is the electrocardiogram without evidence of acute cardiac ischemia)
    CL Item
    Is The Karnofsky Performance Status > 60 (Is the Karnofsky performance status > 60)
    CL Item
    Is The Patient On Full-dose Anticoagulants (e.g., Warfarin Or Lmw Heparin) (Is the patient on full-dose anticoagulants (e.g., warfarin or LMW heparin))
    CL Item
    Is The Prothrombin Time/international Normalized Ratio (pt Inr) < 1.4 For Patients Not On Warfarin Confirmed By Testing (Is the prothrombin time/international normalized ratio (PT INR) < 1.4 for patients not on warfarin confirmed by testing)
    CL Item
    Is There Adequate Bone Marrow Function Defined As Follows Absolute Neutrophil Count (anc) >= 1,500 Cells/mm^3; Platelets >= 100,000 Cells/mm^3; Hemoglobin >= 10.0 G/dl (note: The Use Of Transfusion Or Other Intervention Is Acceptable) (Is there adequate bone marrow function defined as follows Absolute neutrophil count (ANC) >= 1,500 cells/mm^3; Platelets >= 100,000 cells/mm^3; Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention is acceptable))
    CL Item
    Is There Adequate Hepatic Function, As Defined Below Bilirubin <= 2.0 Mg/dl; Alt/ast <= 3 X Normal Range (Is there adequate hepatic function, as defined below Bilirubin <= 2.0 mg/dl; ALT/AST <= 3 x normal range)
    CL Item
    Is There Adequate Renal Function, As Defined Below Bun <= 30 Mg/dl; Creatinine <= 1.7 Mg/dl; Urine Protein Screened By Urine Analysis For Urine Protein Creatinine (upc) Ratio. For Upc Ratio > 0.5, 24-hour Urine Protein Should Be Obtained (Is there adequate renal function, as defined below BUN <= 30 mg/dl; Creatinine <= 1.7 mg/dl; Urine protein screened by urine analysis for urine protein creatinine (UPC) ratio. For UPC ratio > 0.5, 24-hour urine protein should be obtained)
    CL Item
    Planned Start Date For Salvage Treatment (Planned start date for salvage treatment)
    CL Item
    Was An Mri Or Ct Scan Obtained That Demonstrates The Following: Postoperative Hemorrhage Defined As > 1 Cm Diameter Of Blood (if > 1 Cm Of Acute Blood Is Detected, The Patient May Not Receive Unblinded Bevacizumab) (Was an MRI or CT scan obtained that demonstrates the following: postoperative hemorrhage defined as > 1 cm diameter of blood (if > 1 cm of acute blood is detected, the patient may not receive unblinded bevacizumab))
    CL Item
    Was The Patient Diagnosed With Recurrance Or Progression (must Be Diagnosed By Imaging Only) (Was the patient diagnosed with recurrance or progression (must be diagnosed by imaging only))
    Item
    Performance Status (Karnofsky)
    text
    C25367 (NCI Thesaurus Property)
    C20641 (NCI Thesaurus ObjectClass)
    C1518965 (UMLS 2011AA ObjectClass)
    C25338 (NCI Thesaurus ValueDomain)
    C0449820 (UMLS 2011AA ValueDomain)
    CL.3
    Code List
    Performance Status (Karnofsky)
    CL Item
    Dead (0)
    CL Item
    Moribund, Fatal Processes Progressing Rapidly (10)
    CL Item
    Normal, No Complaints, No Evidence Of Disease (100)
    CL Item
    Very Sick, Hospitalization Indicated. Death Not Imminent (20)
    CL Item
    Severely Disabled, Hospitalization Indicated. Death Not Imminent (30)
    CL Item
    Disabled, Requires Special Care And Assistance (40)
    CL Item
    Requires Considerable Assistance And Frequent Medical Care (50)
    CL Item
    Requires Occasional Assistance, But Is Able To Care For Most Of His/her Needs (60)
    CL Item
    Cares For Self, Unable To Carry On Normal Activity Or To Do Active Work (70)
    CL Item
    Normal Activity With Effort; Some Signs Or Symptoms Of Disease (80)
    CL Item
    Able To Carry On Normal Activity; Minor Signs Or Symptoms Of Disease (90)
    PatientNegativePregnancyTestInd-2
    Item
    Negative serum pregnancy test
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25247 (NCI Thesaurus Property)
    C0205160 (UMLS 2011AA Property)
    C0032976 (NCI Metathesaurus Property)
    SalvageTherapyAdministeredDate
    Item
    Planned start date for salvage treatment
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C15359 (NCI Thesaurus ObjectClass)
    C0085405 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    Item Group
    Footer Module
    Investigator Signature
    Item
    Investigator Signature
    text
    C25704 (NCI Thesaurus ValueDomain)
    C2346576 (UMLS CUI-1)
    C25678 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    Investigator Signature Date
    Item
    Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2346576 (UMLS CUI-1)
    C25678 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-2)
    C25367 (NCI Thesaurus ValueDomain-2)
    C17089 (NCI Thesaurus ObjectClass)
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial