ID

1347

Description

E5204 On-Study Form Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Had Surgery for Stage II or Stage III Rectal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=089B43F4-F7BD-38D3-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=089B43F4-F7BD-38D3-E044-0003BA3F9857

Keywords

Versions (3)
  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/16/15 6/16/15 -
Uploaded on

August 27, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Colorectal Cancer NCT00303628 On-Study - E5204 On-Study Form - 2439400v1.0

English

INSTRUCTIONS: Complete this form within one week of randomization. Submit original to the ECOG Coordinating Center. Keep a copy for your files.

1 forms  
Unnamed1
Description

Unnamed1

ECOG Protocol Number
Description

ProtocolECOGIdentifierNumber

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
C25491
UMLS 2011AA Property
C1512162
ECOG Patient ID
Description

PatientECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
DCI Name
Description

CollectedDataFormName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C19464
UMLS 2011AA Property
C0376315
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus ObjectClass
C25452
Registration Step
Description

RegistrationStepNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25646
UMLS 2011AA ObjectClass
C1514821
NCI Thesaurus Property
C16154
UMLS 2011AA Property
C1704379
NCI Thesaurus ValueDomain
C16154
UMLS 2011AA ValueDomain
C1704379
Report period
Description

ReportingEvaluationPeriodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25214
UMLS 2011AA ObjectClass
C0220825
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C25651
UMLS 2011AA ObjectClass
C0700287
Unnamed2
Description

Unnamed2

Patient Initials (Last, First)
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
ECOG Protocol Number
Description

ProtocolECOGIdentifierNumber

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
C25491
UMLS 2011AA Property
C1512162
Participating Group Protocol Number
Description

ProtocolParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
ECOG Patient ID
Description

PatientECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
Institution/Affiliate
Description

CombinedInstitutionName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Participating Group Patient ID
Description

PatientParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Unnamed3
Description

Unnamed3

Please mark an 'X' if data have been amended. (Please circle amended items in red)
Description

DataAmendedText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Date data amended (s - mm/dd/yyyy)
Description

DataAmendedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
NCI Thesaurus ValueDomain
C25367
Baseline Evaluation
Description

Baseline Evaluation

ECOG Performance Status (at study entry)
Description

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25491
UMLS 2011AA ValueDomain
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
Date CEA obtained (CEA - mm/dd/yyyy)
Description

CarcinoembryonicAntigenSpecimenCollectionDate

Data type

text

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25159
UMLS 2011AA ObjectClass
C0007082
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
CEA Value (ng/ml)
Description

LaboratoryProcedureCarcinoembryonicAntigenOutcomeValue

Data type

text

Alias
NCI Thesaurus Property
C25159
UMLS 2011AA Property
C0007082
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
CEA ULN
Description

LaboratoryProcedureCarcinoembryonicAntigenOutcomeUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25159
UMLS 2011AA Property
C0007082
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Is patient hypertensive
Description

HypertensionPresentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C3117
UMLS 2011AA ObjectClass
C0020538
Is patient on anti-hypertensive therapy
Description

HypertensionTreatmentReceivedInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3117
UMLS 2011AA ObjectClass
C0020538
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C15368
Patient receiving full-dose anticoagulants
Description

FullDoseAnticoagulantAgentCurrentUseInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ObjectClass
C263
UMLS 2011AA ObjectClass
C0003280
NCI Thesaurus ObjectClass
C25517
UMLS 2011AA ObjectClass
C0443225
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Weight (kg)
Description

PatientWeightMeasurement

Data type

double

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25208
UMLS 2011AA Property
C0043100
Kg
Weight 1 year ago (patient self-report - kg)
Description

PatientLastYearWeightMeasurement

Data type

double

Measurement units
  • Kg
Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C29848
UMLS 2011AA Property
C0439234
NCI Thesaurus Property
C25208
UMLS 2011AA Property
C0043100
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Kg
Height (cm)
Description

PatientHeightMeasurement

Data type

double

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25347
UMLS 2011AA Property
C0489786
cm
Diabetes History
Description

Diabetes History

Diabetes Mellitus
Description

DiabetesMellitusHistoryInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C2985
UMLS 2011AA ObjectClass
C0011849
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Approximate year of diagnosis (yyyy)
Description

DiabetesMellitusDiagnosisYearDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C2985
UMLS 2011AA ObjectClass
C0011849
NCI Thesaurus ValueDomain
C29848
UMLS 2011AA ValueDomain
C0439234
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Is patient insulin dependent
Description

InsulinDependentDiabetesMellitusPresentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2986
UMLS 2011AA ObjectClass
C0011854
Approximate year insulin started (yyyy)
Description

InsulinDependentDiabetesMellitusPresentYearDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C29848
UMLS 2011AA ValueDomain
C0439234
NCI Thesaurus ObjectClass
C2986
UMLS 2011AA ObjectClass
C0011854
Does patient manage his/her diabetes with oral medications
Description

DiabetesMellitusOralMedicationPatientUseInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C2985
UMLS 2011AA ObjectClass
C0011849
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass
C25311
UMLS 2011AA ObjectClass
C0442027
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Pathologic Staging
Description

Pathologic Staging

Histologic Grade (Differentiation) ([From pre-treatment biopsy specimen])
Description

ColorectalTumorHistologicGrade

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
NCI Thesaurus ValueDomain
C25526
UMLS 2011AA ValueDomain
C0205462
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
Perforation
Description

TumorPerforationInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C4080
UMLS 2011AA Property
C0549099
Obstruction
Description

ObstructionPresentInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Metathesaurus ObjectClass
C0028778
Clinical T Stage (Use the staging definitions in Appendix V of the protocol)
Description

ColorectalTumorClinicalTStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property
C25728
UMLS 2011AA Property
C0475455
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Clinical N Stage (Use the staging definitions in Appendix V of the protocol)
Description

ColorectalTumorClinicalNStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property
C25580
UMLS 2011AA Property
C0456532
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Clinical M Stage (Use the staging definitions in Appendix V of the protocol)
Description

ColorectalTumorClinicalMStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property
C25727
UMLS 2011AA Property
C0456533
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Stage Grouping Assessment Method
Description

ColorectalTumorStageGroupingAssessmentType

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property
C38027
UMLS 2011AA Property
C1519504
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Pathologic T Stage (Use the staging definitions in Appendix V of the protocol)
Description

ColorectalTumorPathologicTStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property
C25728
UMLS 2011AA Property
C0475455
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Pathologic N Stage (Use the staging definitions in Appendix V of the protocol)
Description

ColorectalTumorPathologicNStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property
C25580
UMLS 2011AA Property
C0456532
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Pathologic M Stage (Use the staging definitions in Appendix V of the protocol)
Description

ColorectalTumorPathologicMStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property
C25727
UMLS 2011AA Property
C0456533
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Biological Markers
Description

Biological Markers

Regimen Type Given
Description

PriorColorectalTreatmentCombinedRegimenType

Data type

text

Alias
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25454
UMLS 2011AA Property
C0205195
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Chemotherapy Begin Date (mm/dd/yyyy)
Description

ChemotherapyAdministeredBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Chemotherapy End Date (mm/dd/yyyy)
Description

ChemotherapyAdministeredEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
RT Total Dose (Gy)
Description

RTAdministeredTotalDose

Data type

double

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Total Number of Fractions
Description

RadiationTherapyTotalFractionsCount

Data type

double

Alias
NCI Thesaurus Property
C25304
UMLS 2011AA Property
C0439810
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25514
UMLS 2011AA Property
C1264633
RT Begin Date (mm/dd/yyyy)
Description

RTBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
RT End Date (mm/dd/yyyy)
Description

RTEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus Property
C25496
UMLS 2011AA Property
C2746065
Prior Surgery For This Disease
Description

Prior Surgery For This Disease

Primary Surgery Type
Description

ColorectalPrimarySurgicalProcedurePerformedType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property
C47863
UMLS 2011AA Property
C0205231
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other specify
Description

PrimarySurgicalProcedurePerformedSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
Primary Surgery Date (mm/dd/yyyy)
Description

PrimarySurgeryDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Was sphincter preserved
Description

ColorectalSurgicalProcedureSphincterPreservedInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C28381
UMLS 2011AA Property
C1409894
NCI Metathesaurus Property
C0456735
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was the tumor fixed to surrounding structures
Description

ColorectalTumorSurroundingStructureFixedInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Metathesaurus Property
C1185713
NCI Thesaurus Property
C41186
UMLS 2011AA Property
C0678594
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was a complete resection done?
Description

PriorResectionSurgicalPerformedInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C15232
UMLS 2011AA ObjectClass
C0728940
NCI Thesaurus Property
C25698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Were all lymph nodes suggestive of disease removed?
Description

LymphNodeRemovedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus Property
C25650
UMLS 2011AA Property
C0849355
Number of Lymph Nodes Examined
Description

LymphNodeExaminedCount

Data type

double

Alias
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Number of Positive Lymph Nodes
Description

LymphNodePositiveCount

Data type

double

Alias
NCI Thesaurus Property
C25246
UMLS 2011AA Property
C1446409
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Baseline Abnormalities
Description

Baseline Abnormalities

CTC Adverse Event Term (include subterm if applicable - Use CTCAE v3 terminology)
Description

CommonToxicityCriteriaAdverseEventTermType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC Adverse Event Grade (Use grade 1-4 per CTCAE v3)
Description

CommonToxicityCriteriaAdverseEventGrade

Data type

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Comments
Description

Comments

Investigator Signature
Description

InvestigatorSignatureText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Investigator Signature Date
Description

InvestigatorSignatureDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
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Similar models

INSTRUCTIONS: Complete this form within one week of randomization. Submit original to the ECOG Coordinating Center. Keep a copy for your files.

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
ProtocolECOGIdentifierNumber
Item
ECOG 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)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
CollectedDataFormName
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ObjectClass)
RegistrationStepNumber
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)
Item
Report period
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus ObjectClass)
C0700287 (UMLS 2011AA ObjectClass)
CL.1
Code List
Report period
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
Item Group
Unnamed2
PatientInitialsName
Item
Patient Initials (Last, First)
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)
ProtocolECOGIdentifierNumber
Item
ECOG 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)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item Group
Unnamed3
DataAmendedText
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
DataAmendedDate
Item
Date data amended (s - mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
Item Group
Baseline Evaluation
Item
ECOG Performance Status (at study entry)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
CL.2
Code List
ECOG Performance Status (at study entry)
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0=)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1=)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2=)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3=)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4=)
CarcinoembryonicAntigenSpecimenCollectionDate
Item
Date CEA obtained (CEA - mm/dd/yyyy)
text
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25159 (NCI Thesaurus ObjectClass)
C0007082 (UMLS 2011AA ObjectClass)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
LaboratoryProcedureCarcinoembryonicAntigenOutcomeValue
Item
CEA Value (ng/ml)
text
C25159 (NCI Thesaurus Property)
C0007082 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCarcinoembryonicAntigenOutcomeUpperLimitNormalValue
Item
CEA ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25159 (NCI Thesaurus Property)
C0007082 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item
Is patient hypertensive
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3117 (NCI Thesaurus ObjectClass)
C0020538 (UMLS 2011AA ObjectClass)
CL.3
Code List
Is patient hypertensive
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Is patient on anti-hypertensive therapy
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3117 (NCI Thesaurus ObjectClass)
C0020538 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
CL.4
Code List
Is patient on anti-hypertensive therapy
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Patient receiving full-dose anticoagulants
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C263 (NCI Thesaurus ObjectClass)
C0003280 (UMLS 2011AA ObjectClass)
C25517 (NCI Thesaurus ObjectClass)
C0443225 (UMLS 2011AA ObjectClass)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.5
Code List
Patient receiving full-dose anticoagulants
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PatientWeightMeasurement
Item
Weight (kg)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)
PatientLastYearWeightMeasurement
Item
Weight 1 year ago (patient self-report - kg)
double
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus Property)
C0439234 (UMLS 2011AA Property)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
PatientHeightMeasurement
Item
Height (cm)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
Item Group
Diabetes History
Item
Diabetes Mellitus
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2985 (NCI Thesaurus ObjectClass)
C0011849 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.6
Code List
Diabetes Mellitus
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
DiabetesMellitusDiagnosisYearDate
Item
Approximate year of diagnosis (yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C2985 (NCI Thesaurus ObjectClass)
C0011849 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Item
Is patient insulin dependent
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2986 (NCI Thesaurus ObjectClass)
C0011854 (UMLS 2011AA ObjectClass)
CL.7
Code List
Is patient insulin dependent
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
InsulinDependentDiabetesMellitusPresentYearDate
Item
Approximate year insulin started (yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C2986 (NCI Thesaurus ObjectClass)
C0011854 (UMLS 2011AA ObjectClass)
Item
Does patient manage his/her diabetes with oral medications
text
C2985 (NCI Thesaurus ObjectClass)
C0011849 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass)
C0442027 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.8
Code List
Does patient manage his/her diabetes with oral medications
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Pathologic Staging
Item
Histologic Grade (Differentiation) ([From pre-treatment biopsy specimen])
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
CL.9
Code List
Histologic Grade (Differentiation) ([From pre-treatment biopsy specimen])
CL Item
Well Differentiated (Well Differentiated (Grade I))
C14171 (NCI Thesaurus)
C0205615 (UMLS 2011AA)
CL Item
Moderately Differentiated (Moderately Differentiated (Grade II))
C14162 (NCI Thesaurus)
C0205616 (UMLS 2011AA)
CL Item
Poorly Differentiated (Poorly differentiated (Grade III))
C14167 (NCI Thesaurus)
C0205617 (UMLS 2011AA)
CL Item
Undifferentiated (Undifferentiated (Grade IV))
C14176 (NCI Thesaurus)
C0205618 (UMLS 2011AA)
Item
Perforation
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C4080 (NCI Thesaurus Property)
C0549099 (UMLS 2011AA Property)
CL.10
Code List
Perforation
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Obstruction
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C0028778 (NCI Metathesaurus ObjectClass)
CL.11
Code List
Obstruction
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Clinical T Stage (Use the staging definitions in Appendix V of the protocol)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property)
C0475455 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.12
Code List
Clinical T Stage (Use the staging definitions in Appendix V of the protocol)
CL Item
Tumor Invades Submucosa (T1)
CL Item
Tumor Invades Muscularis Propria (T2)
CL Item
Tumor Invades Through The Muscularis Propria Into The Subserosa, Or Into Nonperitonealized Pericolic Or Perirectal Tissues (T3)
CL Item
Tumor Directly Invades Other Organs Or Structures, And/or Perforates Visceral Peritoneum (T4)
Item
Clinical N Stage (Use the staging definitions in Appendix V of the protocol)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property)
C0456532 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.13
Code List
Clinical N Stage (Use the staging definitions in Appendix V of the protocol)
CL Item
No Regional Lymph Node Metastasis (N0)
CL Item
Metastasis In 1 To 3 Regional Lymph Nodes (N1)
CL Item
Metastasis In 4 Or More Regional Lymph Nodes (N2)
Item
Clinical M Stage (Use the staging definitions in Appendix V of the protocol)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property)
C0456533 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.14
Code List
Clinical M Stage (Use the staging definitions in Appendix V of the protocol)
CL Item
No Distant Metastasis (M0)
Item
Stage Grouping Assessment Method
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38027 (NCI Thesaurus Property)
C1519504 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.15
Code List
Stage Grouping Assessment Method
CL Item
Endoscopic Ultrasound (Endoscopic ultrasound)
CL Item
Magnetic Resonance Imaging (MRI)
C16809 (NCI Thesaurus)
C0024485 (UMLS 2011AA)
CL Item
Ct Scan (CT Scan)
CL Item
Physical Exam (Physical Exam)
Item
Pathologic T Stage (Use the staging definitions in Appendix V of the protocol)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property)
C0475455 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.16
Code List
Pathologic T Stage (Use the staging definitions in Appendix V of the protocol)
CL Item
Tumor Invades Submucosa (T1)
CL Item
Tumor Invades Muscularis Propria (T2)
CL Item
Tumor Invades Through The Muscularis Propria Into The Subserosa, Or Into Nonperitonealized Pericolic Or Perirectal Tissues (T3)
CL Item
Tumor Directly Invades Other Organs Or Structures, And/or Perforates Visceral Peritoneum (T4)
Item
Pathologic N Stage (Use the staging definitions in Appendix V of the protocol)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property)
C0456532 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.17
Code List
Pathologic N Stage (Use the staging definitions in Appendix V of the protocol)
CL Item
No Regional Lymph Node Metastasis (N0)
CL Item
Metastasis In 1 To 3 Regional Lymph Nodes (N1)
CL Item
Metastasis In 4 Or More Regional Lymph Nodes (N2)
Item
Pathologic M Stage (Use the staging definitions in Appendix V of the protocol)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property)
C0456533 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.18
Code List
Pathologic M Stage (Use the staging definitions in Appendix V of the protocol)
CL Item
No Distant Metastasis (M0)
CL Item
Distant Metastasis (M1)
C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)
Item Group
Biological Markers
Item
Regimen Type Given
text
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C25454 (NCI Thesaurus Property)
C0205195 (UMLS 2011AA Property)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.19
Code List
Regimen Type Given
CL Item
Xrt + Ci 5-fu X 7d (XRT + CI 5-FU x 7d)
CL Item
Xrt + 5-fu/lv (leucovorin) (XRT + 5-FU/LV)
CL Item
Xrt + Capecitabine (XRT + Capecitabine)
CL Item
Xrt + Ci 5-fu X 5d (XRT + CI 5-FU x 5d)
CL Item
Xrt + Capecitabine + Oxaliplatin (XRT + Capecitabine + Oxaliplatin)
CL Item
Xrt + Ci 5-fu + Oxaliplatin (XRT + CI 5-FU + Oxaliplatin)
ChemotherapyAdministeredBeginDate
Item
Chemotherapy Begin Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
ChemotherapyAdministeredEndDate
Item
Chemotherapy End Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
RTAdministeredTotalDose
Item
RT Total Dose (Gy)
double
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
RadiationTherapyTotalFractionsCount
Item
Total Number of Fractions
double
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25514 (NCI Thesaurus Property)
C1264633 (UMLS 2011AA Property)
RTBeginDate
Item
RT Begin Date (mm/dd/yyyy)
date
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
RTEndDate
Item
RT End Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property)
C2746065 (UMLS 2011AA Property)
Item Group
Prior Surgery For This Disease
Item
Primary Surgery Type
text
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C47863 (NCI Thesaurus Property)
C0205231 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.20
Code List
Primary Surgery Type
CL Item
Low Anterior Resection (Low anterior resection (LAR))
CL Item
Abdominal Perineal Resection (Abdominal perineal resection (APR))
CL Item
Low Anterior Resection/coloanal Anastomosis (Low anterior resection/coloanal anastomosis (LAR/CAA))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PrimarySurgicalProcedurePerformedSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
PrimarySurgeryDate
Item
Primary Surgery Date (mm/dd/yyyy)
date
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
Item
Was sphincter preserved
text
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C28381 (NCI Thesaurus Property)
C1409894 (UMLS 2011AA Property)
C0456735 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.21
Code List
Was sphincter preserved
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Was the tumor fixed to surrounding structures
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C1185713 (NCI Metathesaurus Property)
C41186 (NCI Thesaurus Property)
C0678594 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.22
Code List
Was the tumor fixed to surrounding structures
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Was a complete resection done?
text
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15232 (NCI Thesaurus ObjectClass)
C0728940 (UMLS 2011AA ObjectClass)
C25698 (NCI Thesaurus Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.23
Code List
Was a complete resection done?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Were all lymph nodes suggestive of disease removed?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25650 (NCI Thesaurus Property)
C0849355 (UMLS 2011AA Property)
CL.24
Code List
Were all lymph nodes suggestive of disease removed?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LymphNodeExaminedCount
Item
Number of Lymph Nodes Examined
double
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
LymphNodePositiveCount
Item
Number of Positive Lymph Nodes
double
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item Group
Baseline Abnormalities
CommonToxicityCriteriaAdverseEventTermType
Item
CTC Adverse Event Term (include subterm if applicable - Use CTCAE v3 terminology)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Item
CTC Adverse Event Grade (Use grade 1-4 per CTCAE v3)
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.25
Code List
CTC Adverse Event Grade (Use grade 1-4 per CTCAE v3)
CL Item
Mild Adverse Event (1)
C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
Item Group
Comments
InvestigatorSignatureText
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
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