ID

8296

Beschreibung

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

Stichworte

  1. 26.08.12 26.08.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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

No Instruction available.

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

Module 1

RTOG Study No.
Beschreibung

Protocol ID RTOG

Datentyp

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 #
Beschreibung

RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

Datentyp

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
Beschreibung

Institution Name

Datentyp

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.
Beschreibung

Institution Number

Datentyp

text

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

Patient Initials

Datentyp

text

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

Trial subject ID RTOG

Datentyp

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)
Beschreibung

Data amended

Datentyp

boolean

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

Inclusion Criteria

Inclusion Criteria
Beschreibung

RadiationTherapyOncologyGroupPatientInclusionClinicalTrialEligibilityCriteria0825Type

Datentyp

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)
Beschreibung

KarnofskyPerformanceStatusScore

Datentyp

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
Beschreibung

PatientNegativePregnancyTestInd-2

Datentyp

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
Beschreibung

SalvageTherapyAdministeredDate

Datentyp

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
Beschreibung

Footer Module

Investigator Signature
Beschreibung

Investigator Signature

Datentyp

text

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

Investigator Signature Date

Datentyp

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

Ähnliche Modelle

No Instruction available.

  1. StudyEvent: RTOG 0825 Phase III GBM Salvage Treatment Guideline Questionnaire (SX)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
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)
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)

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