ID

23804

Description

Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases That Have Been Removed By Surgery Cognitive/Functional Effects NCT01372774 Eligibility - N107C Randomization (Step 2) Form and Eligibility Checklist - 3226595v1.0 https://clinicaltrials.gov/ct2/show/NCT01372774

Link

https://clinicaltrials.gov/ct2/show/NCT01372774

Keywords

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

July 14, 2017

DOI

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License

Creative Commons BY 4.0
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Brain Metastases Stereotactic Radiosurgery or Whole-Brain Radiation NCT01372774 N107C

English

No Instruction available.

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

Pre-treatment Requirements

Alias
UMLS CUI-1
C0013893
Maximum 3 unresected lesions, below 3 cm
Description

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)

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C12439
NCI Thesaurus Property-2
C19151
NCI Thesaurus Property-3
C16112
NCI Thesaurus ValueDomain
C38147
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C2986425
resection cavity below 5.0 cm
Description

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)

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C3824
NCI Thesaurus Property-2
C12439
NCI Thesaurus Property-3
C25654
NCI Thesaurus Property-4
C16112
NCI Thesaurus ValueDomain
C38147
UMLS CUI [1]
C1515091
no pregnancy
Description

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)

Data type

integer

Alias
NCI Thesaurus ValueDomain
C25180
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25247
NCI Metathesaurus Property
C0032976
UMLS CUI [1]
C0232973
Negative urine or serum pregnancy test date
Description

If a woman of childbearing potential

Data type

date

Measurement units
  • mm/dd/yyyy
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25247
NCI Metathesaurus Property
C0032976
UMLS CUI [1,1]
C0427780
UMLS CUI [1,2]
C0011008
mm/dd/yyyy
Registration Check
Description

Registration Check

Alias
UMLS CUI-1
C1514821
Treatment on this protocol must commence at the accruing membership under the supervision of a CTSU or NCCTG member physician
Description

supervision of CTSU or NCCTG physician

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C25581
NCI Thesaurus Property
C15368
NCI Thesaurus ObjectClass-2
C61372
UMLS CUI [1,1]
C4035957
UMLS CUI [1,2]
C1518419
Treatment cannot begin prior to randomization and must begin <=21 days after randomization
Description

Begin Therapy Post Randomization

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25431
NCI Thesaurus Property
C25196
NCI Thesaurus Property-2
C38008
NCI Thesaurus ValueDomain
C38147
UMLS CUI [1,1]
C3173309
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0034656
Tests/procedures must be completed after pre-registration, but prior to randomization
Description

see Section 4.0 for further details Note: Quality of Life; Functional independence; and Neurocognitive evaluation completed after informed consent and prior to randomization

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25646
NCI Thesaurus Property-2
C25629
NCI Thesaurus Property-3
C25294
NCI Thesaurus Property-4
C45513
NCI Thesaurus ValueDomain
C38147
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0034656
Date Informed Consent Signed
Description

from pre-registration checklist

Data type

date

Measurement units
  • mm/dd/yyyy
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
NCI Thesaurus Property
C25679
UMLS CUI [1]
C2985782
mm/dd/yyyy
Earliest test/procedure date
Description

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

Data type

date

Measurement units
  • mm/dd/yyyy
Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25646
NCI Thesaurus Property-2
C25629
NCI Thesaurus Property-3
C25294
NCI Thesaurus Property-4
C25171
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI [1,1]
C1115465
UMLS CUI [1,2]
C0022885
mm/dd/yyyy
Labtest test/procedure date
Description

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

Data type

date

Measurement units
  • mm/dd/yyyy
Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25646
NCI Thesaurus Property-2
C25629
NCI Thesaurus Property-3
C25294
NCI Thesaurus Property-4
C25171
NCI Thesaurus ValueDomain
C25164
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0022885
mm/dd/yyyy
Stratification Factors
Description

Stratification Factors

Alias
UMLS CUI-1
C1514984
Age
Description

Age

Data type

text

Measurement units
  • years
Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25320
NCI Thesaurus Property-2
C25646
NCI Thesaurus Property-3
C25509
NCI Thesaurus ValueDomain
C29848
NCI Thesaurus ValueDomain-2
C25463
UMLS CUI [1]
C0001779
Number of Preoperative Brain Metastases
Description

Brain metastases, count

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C19151
NCI Thesaurus ValueDomain
C25463
NCI Thesaurus Property-2
C25689
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0750480
Resection cavity maximal diameter
Description

Resection cavity maximal diameter

Data type

text

Alias
NCI Thesaurus ObjectClass
C12439
NCI Thesaurus ObjectClass-2
C20051
NCI Thesaurus Property
C25285
NCI Thesaurus Property-2
C25564
NCI Thesaurus ValueDomain
C25284
UMLS CUI [1,1]
C1515091
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0205289
Extracranial disease controlled
Description

Controlled disease extracranial

Data type

text

Measurement units
  • months
Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus ValueDomain
C25688
NCI Thesaurus Property
C94424
NCI Thesaurus Property-2
C82500
UMLS CUI [1,1]
C2911690
UMLS CUI [1,2]
C0580586
Histology
Description

Tumor histology

Data type

integer

Alias
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus ObjectClass-2
C14174
NCI Thesaurus Property
C25526
NCI Thesaurus Property-2
C25696
NCI Thesaurus ValueDomain
C25372
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0006826
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Similar models

No Instruction available.

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
C0013893 (UMLS CUI-1)
Unresected lesions
Item
Maximum 3 unresected lesions, below 3 cm
boolean
C16960 (NCI Thesaurus ObjectClass)
C12439 (NCI Thesaurus Property)
C19151 (NCI Thesaurus Property-2)
C16112 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0221198 (UMLS CUI [1,1])
C2986425 (UMLS CUI [1,2])
resection cavity
Item
resection cavity below 5.0 cm
boolean
C16960 (NCI Thesaurus ObjectClass)
C3824 (NCI Thesaurus Property)
C12439 (NCI Thesaurus Property-2)
C25654 (NCI Thesaurus Property-3)
C16112 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1515091 (UMLS CUI [1])
Item
no pregnancy
integer
C25180 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25247 (NCI Thesaurus Property)
C0032976 (NCI Metathesaurus Property)
C0232973 (UMLS CUI [1])
CL.3
Code List
no pregnancy
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
CL Item
No (2)
C1298908 (UMLS CUI-1)
CL Item
N/A (3)
C1272460 (UMLS CUI-1)
Negative Pregnancy Test Date
Item
Negative urine or serum pregnancy test date
date
C25164 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25247 (NCI Thesaurus Property)
C0032976 (NCI Metathesaurus Property)
C0427780 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Registration Check
C1514821 (UMLS CUI-1)
supervision of CTSU or NCCTG physician
Item
Treatment on this protocol must commence at the accruing membership under the supervision of a CTSU or NCCTG member physician
boolean
C38147 (NCI Thesaurus ValueDomain)
C25581 (NCI Thesaurus ObjectClass)
C15368 (NCI Thesaurus Property)
C61372 (NCI Thesaurus ObjectClass-2)
C4035957 (UMLS CUI [1,1])
C1518419 (UMLS CUI [1,2])
Begin Therapy Post Randomization
Item
Treatment cannot begin prior to randomization and must begin <=21 days after randomization
boolean
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ObjectClass-2)
C25196 (NCI Thesaurus Property)
C38008 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C3173309 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
Patient Prior Registration Laboratory Procedure Verification
Item
Tests/procedures must be completed after pre-registration, but prior to randomization
boolean
C16960 (NCI Thesaurus ObjectClass)
C25646 (NCI Thesaurus Property)
C25629 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus Property-3)
C45513 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
Informed Consent Date
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C25679 (NCI Thesaurus Property)
C2985782 (UMLS CUI [1])
Laboratory Procedure Begin Date Prior Registration
Item
Earliest test/procedure date
date
C16960 (NCI Thesaurus ObjectClass)
C25646 (NCI Thesaurus Property)
C25629 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus Property-3)
C25171 (NCI Thesaurus Property-4)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C1115465 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Laboratory Procedure End Date Prior Registration
Item
Labtest test/procedure date
date
C16960 (NCI Thesaurus ObjectClass)
C25646 (NCI Thesaurus Property)
C25629 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus Property-3)
C25171 (NCI Thesaurus Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0806020 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Item Group
Stratification Factors
C1514984 (UMLS CUI-1)
Item
Age
text
C16960 (NCI Thesaurus ObjectClass)
C25320 (NCI Thesaurus Property)
C25646 (NCI Thesaurus Property-2)
C25509 (NCI Thesaurus Property-3)
C29848 (NCI Thesaurus ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0001779 (UMLS CUI [1])
CL.7
Code List
Age
CL Item
60 Years Of Age (60)
CL Item
60=>=60 Years Of Age ()
Item
Number of Preoperative Brain Metastases
text
C16960 (NCI Thesaurus ObjectClass)
C19151 (NCI Thesaurus Property)
C25463 (NCI Thesaurus ValueDomain)
C25689 (NCI Thesaurus Property-2)
C0220650 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
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)
C20051 (NCI Thesaurus ObjectClass-2)
C25285 (NCI Thesaurus Property)
C25564 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
C1515091 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0205289 (UMLS CUI [1,3])
CL.9
Code List
Resection cavity maximal diameter
CL Item
Resection Cavity Maximal Diameter <=3 Cm ()
CL Item
Resection Cavity Maximal Diameter >3 Cm (3 cm)
Item
Extracranial disease controlled
text
C25190 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C94424 (NCI Thesaurus Property)
C82500 (NCI Thesaurus Property-2)
C2911690 (UMLS CUI [1,1])
C0580586 (UMLS CUI [1,2])
CL.10
Code List
Extracranial disease controlled
CL Item
Extracranial Disease Controlled up to 3 Months (0-3)
CL Item
Extracranial Disease Controlled over 3 Months (3)
Item
Histology
integer
C3262 (NCI Thesaurus ObjectClass)
C14174 (NCI Thesaurus ObjectClass-2)
C25526 (NCI Thesaurus Property)
C25696 (NCI Thesaurus Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0019638 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
CL.11
Code List
Histology
CL Item
Lung (1)
C0024109 (UMLS CUI-1)
CL Item
Radioresistant (2)
C3890377 (UMLS CUI-1)
CL Item
Other (3)
C0205394 (UMLS CUI-1)
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