ID

1312

Description

N107C Randomization (Step 2) Form and Eligibility Checklist Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases That Have Been Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A06D9FD2-49D6-8C55-E040-BB89AD433C99

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A06D9FD2-49D6-8C55-E040-BB89AD433C99

Keywords

Versions (2)
  1. 8/27/12 8/27/12 -
  2. 7/14/17 7/14/17 - Martin Dugas
Uploaded on

August 27, 2012

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Creative Commons BY-NC 3.0
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Cognitive/Functional Effects NCT01372774 Eligibility - N107C Randomization (Step 2) Form and Eligibility Checklist - 3226595v1.0

English

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1 forms  
  1. StudyEvent: N107C Randomization (Step 2) Form and Eligibility Checklist
    1. No Instruction available.
Pre-treatment Requirements
Description

Pre-treatment Requirements

Planning MRI confirmed zero, one, two, or three unresected lesions. Each unresected lesion must measure <3.0 cm in maximal extent on the contrasted planning MRI brain scan (NOTE: The pre-registration brain scan may be used for the planning scan if obtained <=14 days prior to randomization)
Description

PatientBrainMetastasisClinicalTrialEligibilityCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12439
UMLS 2011AA Property
C0006104
NCI Thesaurus Property
C19151
UMLS 2011AA Property
C0027627
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Planning MRI confirms resection cavity measures <5.0 cm in maximal extent (NOTE: The pre-registration brain scan may be used for the planning scan if obtained <=14 days prior to randomization)
Description

PatientBrainLesionResectedClinicalTrialEligibilityCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3824
UMLS 2011AA Property
C0221198
NCI Thesaurus Property
C12439
UMLS 2011AA Property
C0006104
NCI Thesaurus Property
C25654
UMLS 2011AA Property
C1521996
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Negative urine or serum pregnancy test done <=7 days prior to randomization, for women of childbearing potential only (If not a woman of childbearing potential or male check NA)
Description

PatientNegativePregnancyTestIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25247
UMLS 2011AA Property
C0205160
NCI Metathesaurus Property
C0032976
Negative urine or serum pregnancy test date (If a woman of childbearing potential mm/dd/yyyy)
Description

PatientNegativePregnancyTestDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25247
UMLS 2011AA Property
C0205160
NCI Metathesaurus Property
C0032976
Registration Check
Description

Registration Check

Treatment on this protocol must commence at the accruing membership under the supervision of a CTSU or NCCTG member physician
Description

ManagementNorthCentralCancerTreatmentGroupTherapyInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25581
UMLS 2011AA ObjectClass
C1518419
NCI Thesaurus Property
C15368
NCI Thesaurus ObjectClass
C61372
UMLS 2011AA ObjectClass
C1273870
Treatment cannot begin prior to randomization and must begin <=21 days after randomization
Description

BeginTherapyPostRandomizationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25431
UMLS 2011AA ObjectClass
C0439659
NCI Thesaurus Property
C25196
UMLS 2011AA Property
C0034656
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Tests/procedures must be completed after pre-registration, but prior to randomization (see Section 4.0 for further details Note: Quality of Life; Functional independence; and Neurocognitive evaluation completed after informed consent and prior to randomization)
Description

PatientPriorRegistrationLaboratoryProcedureVerificationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C45513
UMLS 2011AA Property
C1711411
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date Informed Consent Signed (from pre-registration checklist mm/dd/yyyy)
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Earliest test/procedure date (mm/dd/yyyy NOTE: These dates are for the Quality of Life; Functional independence; and Neurocognitive test only. The negative serum or urine pregnancy test date is collected in the Inclusion Criteria above)
Description

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Latest test/procedure date (mm/dd/yyyy NOTE: These dates are for the Quality of Life; Functional independence; and Neurocognitive test only. The negative serum or urine pregnancy test date is collected in the Inclusion Criteria above)
Description

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Stratification Factors
Description

Stratification Factors

Age (years)
Description

PatientFirstProtocolRegistrationAgeYearCount

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus ValueDomain
C29848
UMLS 2011AA ValueDomain
C0439234
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Number of Preoperative Brain Metastases
Description

PatientMetastasisStratificationCount

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C19151
UMLS 2011AA Property
C0027627
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25689
UMLS 2011AA Property
C1514983
Resection cavity maximal diameter
Description

ResectionCavityBrainMaximumDiameterType

Data type

text

Alias
NCI Thesaurus ObjectClass
C12439
UMLS 2011AA ObjectClass
C0006104
NCI Thesaurus ObjectClass
C20051
UMLS 2011AA ObjectClass
C1515091
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property
C25564
UMLS 2011AA Property
C0806909
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Extracranial disease controlled (months)
Description

PersonExtracranialDiseaseControlledStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C94424
NCI Thesaurus Property
C82500
UMLS 2011AA Property
C2911690
Histology
Description

MetaplasticTumorHistologicSubtypeCategory

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C14174
UMLS 2011AA ObjectClass
C0036525
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property
C25696
UMLS 2011AA Property
C0449560
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
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1 forms
  1. StudyEvent: N107C Randomization (Step 2) Form and Eligibility Checklist
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Pre-treatment Requirements
Item
Planning MRI confirmed zero, one, two, or three unresected lesions. Each unresected lesion must measure <3.0 cm in maximal extent on the contrasted planning MRI brain scan (NOTE: The pre-registration brain scan may be used for the planning scan if obtained <=14 days prior to randomization)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12439 (NCI Thesaurus Property)
C0006104 (UMLS 2011AA Property)
C19151 (NCI Thesaurus Property)
C0027627 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.1
Code List
Planning MRI confirmed zero, one, two, or three unresected lesions. Each unresected lesion must measure <3.0 cm in maximal extent on the contrasted planning MRI brain scan (NOTE: The pre-registration brain scan may be used for the planning scan if obtained <=14 days prior to randomization)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Planning MRI confirms resection cavity measures <5.0 cm in maximal extent (NOTE: The pre-registration brain scan may be used for the planning scan if obtained <=14 days prior to randomization)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus Property)
C0221198 (UMLS 2011AA Property)
C12439 (NCI Thesaurus Property)
C0006104 (UMLS 2011AA Property)
C25654 (NCI Thesaurus Property)
C1521996 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.2
Code List
Planning MRI confirms resection cavity measures <5.0 cm in maximal extent (NOTE: The pre-registration brain scan may be used for the planning scan if obtained <=14 days prior to randomization)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Negative urine or serum pregnancy test done <=7 days prior to randomization, for women of childbearing potential only (If not a woman of childbearing potential or male check NA)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
CL.3
Code List
Negative urine or serum pregnancy test done <=7 days prior to randomization, for women of childbearing potential only (If not a woman of childbearing potential or male check NA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
N/a (N/A)
PatientNegativePregnancyTestDate
Item
Negative urine or serum pregnancy test date (If a woman of childbearing potential mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
Item Group
Registration Check
Item
Treatment on this protocol must commence at the accruing membership under the supervision of a CTSU or NCCTG member physician
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25581 (NCI Thesaurus ObjectClass)
C1518419 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C61372 (NCI Thesaurus ObjectClass)
C1273870 (UMLS 2011AA ObjectClass)
CL.4
Code List
Treatment on this protocol must commence at the accruing membership under the supervision of a CTSU or NCCTG member physician
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Treatment cannot begin prior to randomization and must begin <=21 days after randomization
text
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ObjectClass)
C0439659 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.5
Code List
Treatment cannot begin prior to randomization and must begin <=21 days after randomization
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Tests/procedures must be completed after pre-registration, but prior to randomization (see Section 4.0 for further details Note: Quality of Life; Functional independence; and Neurocognitive evaluation completed after informed consent and prior to randomization)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C45513 (NCI Thesaurus Property)
C1711411 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.6
Code List
Tests/procedures must be completed after pre-registration, but prior to randomization (see Section 4.0 for further details Note: Quality of Life; Functional independence; and Neurocognitive evaluation completed after informed consent and prior to randomization)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (from pre-registration checklist mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate
Item
Earliest test/procedure date (mm/dd/yyyy NOTE: These dates are for the Quality of Life; Functional independence; and Neurocognitive test only. The negative serum or urine pregnancy test date is collected in the Inclusion Criteria above)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate
Item
Latest test/procedure date (mm/dd/yyyy NOTE: These dates are for the Quality of Life; Functional independence; and Neurocognitive test only. The negative serum or urine pregnancy test date is collected in the Inclusion Criteria above)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Stratification Factors
Item
Age (years)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
CL.7
Code List
Age (years)
CL Item
<60 Years Of Age (<60)
CL Item
>=60 Years Of Age (>=60)
Item
Number of Preoperative Brain Metastases
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus Property)
C0027627 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25689 (NCI Thesaurus Property)
C1514983 (UMLS 2011AA Property)
CL.8
Code List
Number of Preoperative Brain Metastases
CL Item
1 (1)
CL Item
2 To 4 Metastases (2 to 4)
Item
Resection cavity maximal diameter
text
C12439 (NCI Thesaurus ObjectClass)
C0006104 (UMLS 2011AA ObjectClass)
C20051 (NCI Thesaurus ObjectClass)
C1515091 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25564 (NCI Thesaurus Property)
C0806909 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.9
Code List
Resection cavity maximal diameter
CL Item
Resection Cavity Maximal Diameter <=3 Cm (<=3 cm)
CL Item
Resection Cavity Maximal Diameter >3 Cm (>3 cm)
Item
Extracranial disease controlled (months)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C94424 (NCI Thesaurus Property)
C82500 (NCI Thesaurus Property)
C2911690 (UMLS 2011AA Property)
CL.10
Code List
Extracranial disease controlled (months)
CL Item
Extracranial Disease Controlled <=3 Months (<=3)
CL Item
Extracranial Disease Controlled >3 Months (>3)
Item
Histology
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus ObjectClass)
C0036525 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25696 (NCI Thesaurus Property)
C0449560 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
CL.11
Code List
Histology
CL Item
Lung (Lung)
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Radioresistant (Radioresistant)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
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