ID

10960

Descrizione

E5204 On-Study Form NCT00303628 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

collegamento

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

Keywords

D015179

Clinical Trial

On-Study Form

Caricato su

16 giugno 2015

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy

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E5204 On-Study Form NCT00303628

model
Dettagli

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

1 moduli

StudyEvent: E5204 On-Study Form
1. INSTRUCTIONS: Complete this form within one week of randomization. Submit original to the ECOG Coordinating Center. Keep a copy for your files.

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Header

Item Group

Header

Protocol Number ECOG

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Patient ID ECOG

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Generic drug form

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)

Registration Number

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)

Clinical Trial Period

Item

Report period

text

C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)

CL.1

Code List

Report period

CL Item

Baseline (Baseline)

C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)

Data amended

Item

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

text

C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Data amended date

Item

Date data amended (s - mm/dd/yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)

Patient demographics

Item Group

Patient demographics

Patient Initials

Item

Patient Initials (Last, First)

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Study Number Participating Group

Item

Participating Group Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Institution Name

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)

Trial subject ID Participating Group

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Baseline Evaluation

Item Group

Baseline Evaluation

ECOG Performance Status

Item

ECOG Performance Status (at study entry)

text

C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus 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-2)
C0370003 (UMLS 2011AA ObjectClass-2)

LaboratoryProcedureCarcinoembryonicAntigenOutcomeValue

Item

CEA Value (ng/ml)

text

C25159 (NCI Thesaurus Property)
C0007082 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureCarcinoembryonicAntigenOutcomeUpperLimitNormalValue

Item

CEA ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25159 (NCI Thesaurus Property)
C0007082 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

HypertensionPresentInd-2

Item

Is patient hypertensive

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3117 (NCI Thesaurus ObjectClass)
C0020538 (UMLS 2011AA ObjectClass)

HypertensionTreatmentReceivedInd-2

Item

Is patient on anti-hypertensive therapy

boolean

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-2)

FullDoseAnticoagulantAgentCurrentUseInd-2

Item

Patient receiving full-dose anticoagulants

boolean

C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C263 (NCI Thesaurus ObjectClass-2)
C0003280 (UMLS 2011AA ObjectClass-2)
C25517 (NCI Thesaurus ObjectClass-3)
C0443225 (UMLS 2011AA ObjectClass-3)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

Patient Weight

Item

Weight (kg)

float

C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)

PatientLastYearWeightMeasurement

Item

Weight 1 year ago (patient self-report - kg)

float

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus Property)
C0439234 (UMLS 2011AA Property)
C25208 (NCI Thesaurus Property-2)
C0043100 (UMLS 2011AA Property-2)
C25551 (NCI Thesaurus Property-3)
C1517741 (UMLS 2011AA Property-3)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)

Patient Height

Item

Height (cm)

float

C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)

Diabetes History

Item Group

Diabetes History

DiabetesMellitusHistoryInd-3

Item

Diabetes Mellitus

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2985 (NCI Thesaurus ObjectClass)
C0011849 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

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-2)
C0439234 (UMLS 2011AA ValueDomain-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

InsulinDependentDiabetesMellitusPresentInd-2

Item

Is patient insulin dependent

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2986 (NCI Thesaurus ObjectClass)
C0011854 (UMLS 2011AA ObjectClass)

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-2)
C0439234 (UMLS 2011AA ValueDomain-2)
C2986 (NCI Thesaurus ObjectClass)
C0011854 (UMLS 2011AA ObjectClass)

DiabetesMellitusOralMedicationPatientUseInd-2

Item

Does patient manage his/her diabetes with oral medications

boolean

C2985 (NCI Thesaurus ObjectClass)
C0011849 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C25311 (NCI Thesaurus ObjectClass-3)
C0442027 (UMLS 2011AA ObjectClass-3)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

Disease Description

Item Group

Pathologic Staging

ColorectalTumorHistologicGrade

Item

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

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain-2)
C0919553 (UMLS 2011AA ValueDomain-2)

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)

TumorPerforationInd-3

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)

ObstructionPresentInd-3

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)

ColorectalTumorClinicalTStage

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-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
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)

ColorectalTumorClinicalNStage

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-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
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)

ColorectalTumorClinicalMStage

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-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property-2)
C0456533 (UMLS 2011AA Property-2)
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)

ColorectalTumorStageGroupingAssessmentType

Item

Stage Grouping Assessment Method

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38027 (NCI Thesaurus Property-2)
C1519504 (UMLS 2011AA Property-2)
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)

ColorectalTumorPathologicTStage

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-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
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)

ColorectalTumorPathologicNStage

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-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
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)

ColorectalTumorPathologicMStage

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-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property-2)
C0456533 (UMLS 2011AA Property-2)
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)

Prior Treatment for this Disease

Item Group

Biological Markers

PriorColorectalTreatmentCombinedRegimenType

Item

Regimen Type Given

text

C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus ObjectClass-3)
C25454 (NCI Thesaurus Property)
C0205195 (UMLS 2011AA Property)
C15697 (NCI Thesaurus Property-2)
C0040808 (UMLS 2011AA Property-2)
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)

Chemotherapy Start Date

Item

Chemotherapy Begin Date (mm/dd/yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15632 (NCI Thesaurus ObjectClass)
C3173309 (UMLS CUI-2)
C25431 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus 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)

Radiation Therapy Total Dose

Item

RT Total Dose (Gy)

float

C25304 (NCI Thesaurus ValueDomain)
C2169193 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C25488 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)

Total Number of Fractions

Item

Total Number of Fractions

float

C25304 (NCI Thesaurus Property)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C1264633 (UMLS CUI-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS CUI-3)
C25514 (NCI Thesaurus Property-2)

Radiation Therapy Start Date

Item

RT Begin Date (mm/dd/yyyy)

date

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS CUI-1)
C25431 (NCI Thesaurus Property)
C0808070 (UMLS CUI-2)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Radiation Therapy End Date

Item

RT End Date (mm/dd/yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
C25496 (NCI Thesaurus Property-2)

Prior Surgery for this Disease

Item Group

Prior Surgery For This Disease

ColorectalPrimarySurgicalProcedurePerformedType

Item

Primary Surgery Type

text

C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C15329 (NCI Thesaurus ObjectClass-3)
C0543467 (UMLS 2011AA ObjectClass-3)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C47863 (NCI Thesaurus Property-2)
C0205231 (UMLS 2011AA Property-2)
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-2)
C0543467 (UMLS 2011AA ObjectClass-2)

PrimarySurgeryDate

Item

Primary Surgery Date (mm/dd/yyyy)

date

C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

ColorectalSurgicalProcedureSphincterPreservedInd-2

Item

Was sphincter preserved

boolean

C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C28381 (NCI Thesaurus Property)
C1409894 (UMLS 2011AA Property)
C0456735 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

ColorectalTumorSurroundingStructureFixedInd-2

Item

Was the tumor fixed to surrounding structures

boolean

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C1185713 (NCI Metathesaurus Property)
C41186 (NCI Thesaurus Property)
C0678594 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PriorResectionSurgicalPerformedInd-3

Item

Was a complete resection done?

boolean

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15232 (NCI Thesaurus ObjectClass-2)
C0728940 (UMLS 2011AA ObjectClass-2)
C25698 (NCI Thesaurus Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

LymphNodeRemovedInd-3

Item

Were all lymph nodes suggestive of disease removed?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25650 (NCI Thesaurus Property)
C0849355 (UMLS 2011AA Property)

LymphNodeExaminedCount

Item

Number of Lymph Nodes Examined

float

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

float

C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

Baseline Abnormalities

Item Group

Baseline Abnormalities

CTC Adverse Event Term

Item

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

text

C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)

CTC Adverse Event Grade

Item

CTC Adverse Event Grade (Use grade 1-4 per CTCAE v3)

float

C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)

Comments

Item Group

Comments

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

Investigator Signature Date

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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E5204 On-Study Form NCT00303628

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

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