ID

6310

Beskrivning

ECOG-E1505 On-Study Form Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Lung Cancer That Was Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=078250FE-30E9-0714-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=078250FE-30E9-0714-E044-0003BA3F9857

Nyckelord

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18 december 2014

DOI

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Creative Commons BY-NC 3.0 Legacy

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Lung Cancer NCT00324805 On-Study - ECOG-E1505 On-Study Form - 2435616v1.0

model
Detaljer

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

1 Formulär

StudyEvent: ECOG-E1505 On-Study Form
1. INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Unnamed1

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)

ReportingEvaluationPeriodType

Item

Reporting 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

Reporting Period

CL Item

Baseline (Baseline)

C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)

Unnamed2

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

PatientECOGIdentifierNumber

Item

ECOG Patient ID

text

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)

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)

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)

Unnamed 3

Item Group

Unnamed 3

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 (M D Y)

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)

Pre-Treatment Characteristics

Item Group

Unnamed3

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Item

ECOG Performance Status

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

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)

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)

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)

PatientWeightLossPercentageScale

Item

Weight Loss in Previous Six Months

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3445 (NCI Thesaurus Property)
C0043096 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)

CL.3

Code List

Weight Loss in Previous Six Months

CL Item

<5% Of Body Weight (<5% of body weight)

CL Item

5 To <10% Of Body Weight (5 to < 10% of body weight)

CL Item

10 To <20% Of Body Weight (10 -<20% of body weight)

CL Item

> Or = 20% Of Body Weight (> or = 20% of body weight)

UrinaryCreatinineProteinAssessmentValue

Item

Urine Protein/Creatinine Ratio

double

C25711 (NCI Thesaurus ObjectClass)
C1524119 (UMLS 2011AA ObjectClass)
C17021 (NCI Thesaurus ObjectClass)
C0033684 (UMLS 2011AA ObjectClass)
C0010294 (NCI Metathesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

UrinaryProteinCollectionValue

Item

Protein from 24 hour Urine Collection (g - *Value is the total amount of protein, in grams, from a 24-hour urine collection. - Required only if Urine Protein/Creatinine Ration >/= 1.0)

double

C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C17021 (NCI Thesaurus ObjectClass)
C0033684 (UMLS 2011AA ObjectClass)

LaboratoryProcedureEvaluationPerformedDate

Item

Date lab assessment performed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

Patients registered to receive Regimen 4 (Pemetrexed/Cisplatin)

Item Group

Patients Registered To Receive Regimen 4 (pemetrexed/cisplatin)

LaboratoryProcedureCreatinineClearanceOutcomeValue

Item

Creatinine Clearance (Calculated - ml/min)

double

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25747 (NCI Thesaurus Property)
C0373595 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureEvaluationPerformedDate

Item

Date lab assessment performed

date

Cardiac History

Item Group

Patient History

PersonThromboembolismPersonalMedicalHistoryInd-3

Item

Does the patient have a history of thromboembolic events (arterial)

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C0040038 (NCI Metathesaurus Property)

CL.4

Code List

Does the patient have a history of thromboembolic events (arterial)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PersonThromboembolismPersonalMedicalHistorySpecify

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C0040038 (NCI Metathesaurus Property)

CardiovascularDiseasePresentInd-2

Item

Has the patient suffered cardiovascular disease?

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25292 (NCI Thesaurus ObjectClass)
C0007226 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

CL.5

Code List

Has the patient suffered cardiovascular disease?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PatientPriorMyocardialInfarctionInd-3

Item

Myocardial infarction

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27996 (NCI Thesaurus Property)
C0027051 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)

CL.6

Code List

Myocardial infarction

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

StableAnginaDiseasesandDisordersPresentInd-3

Item

Stable Angina

text

C30103 (NCI Thesaurus ObjectClass)
C0205360 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C51221 (NCI Thesaurus ObjectClass)
C0002962 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.7

Code List

Stable Angina

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

UnstableAnginaDiseasePresentInd-3

Item

Unstable angina

text

C25594 (NCI Thesaurus ObjectClass)
C1518422 (UMLS 2011AA ObjectClass)
C30103 (NCI Thesaurus ObjectClass)
C0205360 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C51221 (NCI Thesaurus ObjectClass)
C0002962 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.8

Code List

Unstable angina

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

OtherCardiovascularDiseasePresentInd-3

Item

Other

text

C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25292 (NCI Thesaurus ObjectClass)
C0007226 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.9

Code List

Other

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

OtherCardiovascularDiseasePresentSpecify

Item

Specify (Other)

text

C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25292 (NCI Thesaurus ObjectClass)
C0007226 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

AdverseEventMostRecentRecoveryDate

Item

Recovery or Latest Date (last known date of disease activity - M D Y)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25746 (NCI Thesaurus Property)
C2004454 (UMLS 2011AA Property)
C25577 (NCI Thesaurus Property)
C1513491 (UMLS 2011AA Property)

AdverseEventMostRecentRecoveryDate

Item

Recovery or Latest Date (last known date of disease activity - M D Y)

date

AdverseEventMostRecentRecoveryDate

Item

Recovery or Latest Date (last known date of disease activity - M D Y)

date

AdverseEventMostRecentRecoveryDate

Item

Recovery or Latest Date (last known date of disease activity - M D Y)

date

AdverseEventMostRecentRecoveryDate

Item

Recovery or Latest Date (last known date of disease activity - M D Y)

date

HypertensionHistoryInd-3

Item

Hypertension history

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3117 (NCI Thesaurus ObjectClass)
C0020538 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

CL.10

Code List

Hypertension history

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

NSCLC Disease Description

Item Group

Description Of Disease At Initial Diagnosis

CancerInitialDiagnosisDate

Item

Date of initial pathologic diagnosis (M D Y)

date

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

LungTumorHistologicClassificationLungTumorHistologicCategory

Item

Histologic Type

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)

CL.11

Code List

Histologic Type

CL Item

Squamous Cell Carcinoma (Squamous cell carcinoma)

C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)

CL Item

Adenocarcinoma (Adenocarcinoma)

C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)

CL Item

Large Cell Carcinoma (Large cell carcinoma)

C3780 (NCI Thesaurus)
C0206704 (UMLS 2011AA)

CL Item

Bronchoalveolar (bac) (Bronchoalveolar carcinoma (BAC))

CL Item

Non-small Cell Lung Cancer (nsclc), Nos (Non-small cell lung cancer NOS)

CL Item

Combined/mixed, Specify Subcategories (Combined/mixed)

CL Item

Other (Other specify)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

LungNeoplasmCombinedMixedHistologyClassificationSpecify

Item

Specify combined/mixed histologic types

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25454 (NCI Thesaurus Property)
C0205195 (UMLS 2011AA Property)
C25259 (NCI Thesaurus Property)
C0205430 (UMLS 2011AA Property)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

TumorHistologicCategorySpecify

Item

Specify Other Histologic Type

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)

TumorLungAreaType

Item

Tumor Location Area

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus Property)
C0024109 (UMLS 2011AA Property)
C25244 (NCI Thesaurus Property)
C0205146 (UMLS 2011AA Property)

CL.12

Code List

Tumor Location Area

CL Item

Upper Lobe (right) (Upper Lobe (right))

CL Item

Middle Lobe (right) (Middle Lobe (right))

CL Item

Lower Lobe (right) (Lower Lobe (right))

CL Item

Upper Lobe (left) (Upper Lobe (left))

CL Item

Lingula (Lingula)

CL Item

Lower Lobe (left) (Lower Lobe (left))

CL Item

Other, Specify (Other)

DiseaseInvolvedSiteSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25547 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

LungTumorGroupingStage

Item

Stage (as determined by surgical evaluation)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C25523 (NCI Thesaurus Property)
C1522242 (UMLS 2011AA Property)

CL.13

Code List

Stage (as determined by surgical evaluation)

CL Item

Ib- T2n0 (IB- T2N0)

CL Item

Iia- T1n1 (IIA- T1N1)

CL Item

Iib- T2n1 (IIB- T2N1)

CL Item

Iib- T3n0 (IIB- T3N0)

CL Item

Iiia- T1n2 (IIIA- T1N2)

CL Item

Iiia- T2n2 (IIIA- T2N2)

CL Item

Iiia- T3n1 (IIIA- T3N1)

CL Item

Iiia- T3n2 (IIIA- T3N2)

PathologicTumorPrimarySizeMeasurement

Item

Pathologic Primary Tumor Size

double

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus ObjectClass)
C1521733 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)

ChemotherapyRegimenType

Item

Chemotherapy Regimen

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

CL.14

Code List

Chemotherapy Regimen

CL Item

Cisplatin And Vinorelbine (Cisplatin and Vinorelbine)

CL Item

Cisplatin And Docetaxel (Cisplatin and Docetaxel)

CL Item

Cisplatin And Gemcitabine (Cisplatin and Gemcitabine)

CL Item

Cisplatin And Pemetrexed (Cisplatin and pemetrexed)

Resection Information

Item Group

History Of Disease

LungResectionType

Item

Resection Type (Instruction: Specifying Unknown is not a valid option.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C15232 (NCI Thesaurus Property)
C0728940 (UMLS 2011AA Property)

CL.15

Code List

Resection Type (Instruction: Specifying Unknown is not a valid option.)

CL Item

Intrapericardial Pneumonectomy (Intrapericardial pneumonectomy)

CL Item

Pneumonectomy (Pneumonectomy)

C15305 (NCI Thesaurus)
C0032284 (UMLS 2011AA)

CL Item

Lobectomy (Lobectomy)

C15272 (NCI Thesaurus)
C0023928 (UMLS 2011AA)

CL Item

Bilobectomy (Bilobectomy)

CL Item

Sleeve Lobectomy (Sleeve lobectomy)

CL Item

Lobectomy And Chest Wall Resection (Lobectomy and chest wall resection)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

LungResectionSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C15232 (NCI Thesaurus Property)
C0728940 (UMLS 2011AA Property)

PatientSurgicalResectionDate

Item

Date of Resection

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25698 (NCI Thesaurus Property)
C15232 (NCI Thesaurus Property)
C0728940 (UMLS 2011AA Property)

MediastinalLymphNodePhysicalExaminationType

Item

Type of Mediastinal Lymph Node Dissection (Instruction: Specifying Unknown is not a valid option.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25310 (NCI Thesaurus ObjectClass)
C1522718 (UMLS 2011AA ObjectClass)

CL.16

Code List

Type of Mediastinal Lymph Node Dissection (Instruction: Specifying Unknown is not a valid option.)

CL Item

Incomplete Sampling (Incomplete sampling)

CL Item

Systematic Sampling (Systematic sampling)

CL Item

Complete Mediastinal Lymph Node Dissection (Complete mediastinal lymph node dissection)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

MediastinalLymphNodePhysicalExaminationSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25310 (NCI Thesaurus ObjectClass)
C1522718 (UMLS 2011AA ObjectClass)

MediastinalLymphNodePhysicalExaminationDate

Item

Date of Lymph Node Dissection

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25310 (NCI Thesaurus ObjectClass)
C1522718 (UMLS 2011AA ObjectClass)

PreoperativeMediastinoscopyPerformedInd-2

Item

Pre-operative mediastinoscopy

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16829 (NCI Thesaurus ObjectClass)
C0025065 (UMLS 2011AA ObjectClass)
C54732 (NCI Thesaurus ObjectClass)
C0445204 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)

CL.17

Code List

Pre-operative mediastinoscopy

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PreoperativeMediastinoscopyPerformedDate

Item

Date (If yes)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16829 (NCI Thesaurus ObjectClass)
C0025065 (UMLS 2011AA ObjectClass)
C54732 (NCI Thesaurus ObjectClass)
C0445204 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)

LungTumorPathologicNStage

Item

N Stage, Pathologic

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (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.18

Code List

N Stage, Pathologic

CL Item

No Lymph Node Metastasis (pN0)

CL Item

Metastasis To Ipsilateral Peribronchial And/or Ipsilateral Hilar Lymph Nodes, And Intrapulmonary Nodes Including Involvement By Direct Extension Of The Primary Tumor (pN1)

CL Item

Metastasis To Ipsilateral Mediastinal And/or Subcarinal Lymph Node(s) (pN2)

LymphNodeInvolvementType

Item

Involvement

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

CL.19

Code List

Involvement

CL Item

Negative (negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Not Sampled (Not sampled)

CL Item

Unknown (unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LungLymphNodeInvolvementStatus

Item

Node Levels

text

C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.20

Code List

Node Levels

CL Item

4r (4R)

CL Item

7r (7R)

CL Item

1r (1R)

CL Item

2r (2R)

CL Item

3r (3R)

CL Item

8r (8R)

CL Item

9r (9R)

CL Item

10r (10R)

CL Item

11r (11R)

CL Item

12-14r (12-14R)

CL Item

5 (5)

CL Item

6 (6)

CL Item

7l (7L)

CL Item

1l (1L)

CL Item

2l (2L)

CL Item

3l (3L)

CL Item

4l (4L)

CL Item

8l (8L)

CL Item

9l (9L)

CL Item

10l (10L)

CL Item

11l (11L)

CL Item

12-14l (12-14L)

PatientWoundComplicationPersonalMedicalHistoryInd-2

Item

Does the patient have a history of wound healing complications (Patients must have recovered from any wound healing complications prior to study entry)

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3671 (NCI Thesaurus Property)
C0043250 (UMLS 2011AA Property)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.21

Code List

Does the patient have a history of wound healing complications (Patients must have recovered from any wound healing complications prior to study entry)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PatientWoundComplicationPersonalMedicalHistorySpecify

Item

Specify (If yes:)

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3671 (NCI Thesaurus Property)
C0043250 (UMLS 2011AA Property)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

AdverseEventMostRecentRecoveryDate

Item

Recovery or Latest Date (last known date of disease activity - M D Y)

date

Baseline Abnormalities

Item Group

Baseline Abnormalities

CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName

Item

CTC Adverse Event Term

text

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain)
C1516728 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
C45559 (NCI Thesaurus ValueDomain)
C1705313 (UMLS 2011AA ValueDomain)
C25714 (NCI Thesaurus ValueDomain)
C0333052 (UMLS 2011AA ValueDomain)

AdverseEventSeverityGrade

Item

CTC Adverse Event Grade (v.4.0)

text

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property)
C1710065 (UMLS 2011AA Property)
C25676 (NCI Thesaurus Property)
C0439793 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain)
C0441800 (UMLS 2011AA ValueDomain)
C25676 (NCI Thesaurus ValueDomain)
C0439793 (UMLS 2011AA ValueDomain)

CL.22

Code List

CTC Adverse Event Grade (v.4.0)

CL Item

Mild Adverse Event (1)

C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)

CL Item

Moderate Adverse Event (2)

C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)

CL Item

Severe Adverse Event (3)

C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)

CL Item

Life Threatening Adverse Event (4)

C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)

Footer Module

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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Lung Cancer NCT00324805 On-Study - ECOG-E1505 On-Study Form - 2435616v1.0

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

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