ID

43030

Beskrivning

GOG-0229K: Fast Fact Sheet for Protocol 0229-K (Endometrium) BIBF 1120 in Treating Patients With Recurrent or Persistent Endometrial Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99D51BE9-A450-39B5-E040-BB89AD43255D

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99D51BE9-A450-39B5-E040-BB89AD43255D

Nyckelord

Klinische Studie [Dokumenttyp]

Endometrial Neoplasms

Registration

Uppladdad den

17 september 2021

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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Endometrial Cancer NCT01225887 Pre-Study - GOG-0229K: Fast Fact Sheet for Protocol 0229-K (Endometrium) - 3183206v1.0

model
Detaljer

No Instruction available.

1 Formulär

StudyEvent: GOG-0229K: Fast Fact Sheet for Protocol 0229-K (Endometrium)
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Patient Information

Item Group

Tracking Information

InstitutionGynecologicOncologyGroupIdentifierCode

Item

GOG Institution Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property-2)
C1512288 (UMLS 2011AA Property-2)

AffiliatedInstitutionGynecologicOncologyGroupIdentifierCode

Item

GOG Affiliate Code

text

C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25413 (NCI Thesaurus ObjectClass-2)
C1510826 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property-2)
C1512288 (UMLS 2011AA Property-2)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)

PriorClinicalStudyProtocolGynecologicOncologyGroupIdentifierNumber

Item

Previous GOG #

text

C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property-2)
C1512288 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

TreatingPhysicianName

Item

Treating physician

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)

PhysicianPersonVerificationIdentifierName

Item

Other Physician

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25741 (NCI Thesaurus ObjectClass-2)
C0031831 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C45513 (NCI Thesaurus Property-2)
C1711411 (UMLS 2011AA Property-2)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)

Medical Record Number

Item

Patient Hospital No.

text

C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)

PersonBirthDate

Item

Date of Birth

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)

Last Name

Item

Patient Last Name

text

C25191 (NCI Thesaurus ValueDomain)
C1301584 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)

First Name

Item

Patient First Name

text

C25191 (NCI Thesaurus ValueDomain)
C1443235 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)

PatientMiddleName

Item

Patient Middle Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)

Eligibility 1

Item Group

Header

InformedConsentFormSignedInd-2

Item

Did the patient sign an approved informed consent

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseUpperLimitofNormalResultInd-2

Item

Is the SGOT less than or equal to 3 X ULN (regardless of the presence of liver metastases)

boolean

HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

Item

Has HIPAA authorization been obtained

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)

CL.2

Code List

Has HIPAA authorization been obtained

CL Item

Yes: C49488 (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Exempt - Non-usa Participant (Exempt - non-USA participant)

PersonPriorityGynecologicOncologyGroupClinicalTrialEligibilityCriteriaInd-2

Item

Is the patient eligible for a higher priority GOG protocol

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25521 (NCI Thesaurus Property)
C1512288 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C48911 (NCI Thesaurus Property-3)
C0549179 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

GynecologicMalignantNeoplasmPrimarySite

Item

What is the site of the disease

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass-2)
C0205480 (UMLS 2011AA ObjectClass-2)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property-2)
C0205225 (UMLS 2011AA Property-2)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)

CL.4

Code List

What is the site of the disease

CL Item

Endometrium (Endometrium)

C12313 (NCI Thesaurus)
C0014180 (UMLS 2011AA)

PersonMalignantNeoplasmPathologyClinicalTrialEligibilityCriteriaMalignantNeoplasmPathologyType

Item

What is the cell type?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C18189 (NCI Thesaurus Property-2)
C0030664 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.5

Code List

What is the cell type?

CL Item

Unspecified Adenocarcinoma (Adenocarcinoma, Unspecified)

C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)
C38046 (NCI Thesaurus-3)
C0205370 (UMLS 2011AA-4)

CL Item

Clear Cell Carcinoma (Clear cell carcinoma)

CL Item

Endometrioid Adenocarcinoma (Endometrioid Adenocarcinoma)

C3769 (NCI Thesaurus)
C0206687 (UMLS 2011AA)

CL Item

Mixed Epithelial Carcinoma (Mixed Epithelial Carcinoma)

CL Item

Mucinous Adenocarcinoma (Mucinous Adenocarcinoma)

C26712 (NCI Thesaurus)
C0007130 (UMLS 2011AA)

CL Item

Serous Adenocarcinoma (Serous Adenocarcinoma)

C40101 (NCI Thesaurus)
C0206701 (UMLS 2011AA)

CL Item

Squamous Cell Carcinoma (Squamous Cell Carcinoma)

C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)

CL Item

Transitional Cell Carcinoma (Transitional Cell Carcinoma)

C2930 (NCI Thesaurus)
C0007138 (UMLS 2011AA)

CL Item

Undifferentiated Carcinoma (Undifferentiated Carcinoma)

C3692 (NCI Thesaurus)
C0205698 (UMLS 2011AA)

MalignantNeoplasmInitialHistologicDiagnosisDate

Item

Date of initial histologic diagnosis of malignancy

date

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C25526 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

GynecologicTumorHistologicGrade

Item

What was the grade of the primary tumor

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass-2)
C0205480 (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.6

Code List

What was the grade of the primary tumor

CL Item

Grade 1-well Differentiated (1)

CL Item

Grade 2-moderately Differentiated (2)

CL Item

Grade 3-poorly Differentiated (3)

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionClinicalTrialEligibilityCriteriaStatus

Item

Is the disease recurrent or persistent with documented progression? Which one?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C17747 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.7

Code List

Is the disease recurrent or persistent with documented progression? Which one?

CL Item

Recurrent Disease (Recurrent)

C38155 (NCI Thesaurus)
C0277556 (UMLS 2011AA)

CL Item

Persistent Disease (Persistent)

C90169 (NCI Thesaurus)

DiseaseTreatmentRefractoryInd-2

Item

Is the cancer refractory to curative therapy or established treatment?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionDiagnosisType

Item

How was it established to be recurrent or persistent?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C17747 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C15220 (NCI Thesaurus Property-4)
C0011900 (UMLS 2011AA Property-4)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.9

Code List

How was it established to be recurrent or persistent?

CL Item

Surgical Procedure (Surgery)

C15329 (NCI Thesaurus)
C0543467 (UMLS 2011AA)

CL Item

Biopsy (Biopsy)

C15189 (NCI Thesaurus)
C0005558 (UMLS 2011AA)

CL Item

Non-histologic Evaluation (Non-Histologic)

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionDiagnosisDate

Item

Date recurrence or persistence documented? (NOTE: This should be the date of the most recent progression or persistence that made the patient eligible for this study.)

date

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C17747 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C15220 (NCI Thesaurus Property-4)
C0011900 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

PersonMalignantNeoplasmMeasurableDiseasePresentClinicalTrialEligibilityCriteriaIndicator

Item

Does patient have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded) using RECIST 1.1 criteria?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C8507 (NCI Thesaurus Property-3)
C1513041 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

MalignantNeoplasmMeasurableDiseaseEvaluationMethodClinicalTrialEligibilityCriteriaType

Item

What method of evaluation is used to obtain tumor measurements?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C8507 (NCI Thesaurus Property-3)
C1513041 (UMLS 2011AA Property-3)
C71460 (NCI Thesaurus Property-4)
C0025663 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.11

Code List

What method of evaluation is used to obtain tumor measurements?

CL Item

Computed Tomography (CT)

C17204 (NCI Thesaurus)
C0040405 (UMLS 2011AA)

CL Item

Magnetic Resonance Imaging (MRI)

C16809 (NCI Thesaurus)
C0024485 (UMLS 2011AA)

CL Item

Caliper Measurement By Clinical Exam (Caliper measurement by clinical exam)

CL Item

Chest Radiography (Chest X-ray)

C38103 (NCI Thesaurus)
C0039985 (UMLS 2011AA)

PersonMalignantNeoplasmMeasurableDiseaseSizePresentClinicalTrialEligibilityCriteriaIndicator

Item

Is the measurable disease > or = 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or > or = 20 mm when measured by chest x-ray or lymph nodes > or = 15 mm in short axis when measured by CT or MRI?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C8507 (NCI Thesaurus Property-3)
C1513041 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C25681 (NCI Thesaurus Property-5)
C0456389 (UMLS 2011AA Property-5)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

PersonMalignantNeoplasmMeasurableDiseaseResponseEvaluationCriteriainSolidTumorsClinicalTrialEligibilityCriteriaIndicator

Item

Does the patient have at least one target lesion to be used to assess response on this protocol as defined by RECIST 1.1?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C8507 (NCI Thesaurus Property-2)
C1513041 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C49164 (NCI Thesaurus Property-4)
C1709926 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

PersonMalignantNeoplasmMeasurableDiseaseRadiationFieldClinicalTrialEligibilityCriteriaIndicator

Item

Is the measurable disease in a previously irradiated field?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C8507 (NCI Thesaurus Property-2)
C1513041 (UMLS 2011AA Property-2)
C54648 (NCI Thesaurus Property-3)
C1882536 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

PersonMalignantNeoplasmMeasurableDiseaseRadiationFieldClinicalTrialEligibilityCriteriaInd-3b

Item

If yes, does the patient have disease in an irradiated field as the only site of measurable disease and has progression been documented or a biopsy obtained to confirm persistent disease at least 90 days following completion of radiation treatment?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C8507 (NCI Thesaurus Property-2)
C1513041 (UMLS 2011AA Property-2)
C54648 (NCI Thesaurus Property-3)
C1882536 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)

CL.15

Code List

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

ECOG Performance Status

Item

Performance Status

text

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

CL.16

Code List

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)

PersonThyroidGlandFunctionClinicalTrialEligibilityCriteriaInd-2

Item

Does the patient have normal thyroid function?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C12400 (NCI Thesaurus Property)
C0040132 (UMLS 2011AA Property)
C25518 (NCI Thesaurus Property-2)
C0542341 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonLastTherapeuticProcedureRecoveryClinicalTrialEligibilityCriteriaInd-2

Item

Has the patient recovered from the effects of recent surgery, radiotherapy or chemotherapy?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C25746 (NCI Thesaurus Property-2)
C2004454 (UMLS 2011AA Property-2)
C25551 (NCI Thesaurus Property-3)
C1517741 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonNoInfectionRequiredAntibioticClinicalTrialEligibilityCriteriaInd-2

Item

Is the patient free of active infection requiring antibiotics with the exception of uncomplicated urinary tract infection (UTI)?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C26726 (NCI Thesaurus Property-2)
C0009450 (UMLS 2011AA Property-2)
C258 (NCI Thesaurus Property-3)
C0003232 (UMLS 2011AA Property-3)
C25652 (NCI Thesaurus Property-4)
C1514873 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonMalignantNeoplasmEndocrineTherapyClinicalTrialEligibilityCriteriaInd-2

Item

Has any hormonal therapy directed at the malignant tumor been discontinued at least one week prior to registration?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C15445 (NCI Thesaurus Property-2)
C0279025 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonTherapeuticProcedureDiscontinuedPriorRegistrationClinicalTrialEligibilityCriteriaInd-2

Item

Has all prior therapy directed at the malignant tumor, including immunologic agents, been discontinued for at least three weeks prior to registration?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C49236 (NCI Thesaurus Property-3)
C0087111 (UMLS 2011AA Property-3)
C25484 (NCI Thesaurus Property-4)
C1444662 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PriorCytotoxicChemotherapyUterineEndometrialCarcinomaAdministeredInd-2

Item

Has the patient received one prior chemotherapeutic regimen for management of endometrial carcinoma?

boolean

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15681 (NCI Thesaurus ObjectClass-2)
C0677881 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C7558 (NCI Thesaurus Property-2)
C0476089 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

ChemotherapyRegimenOneReceiveName

Item

Drug Regimen 1:

text

C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C66832 (NCI Thesaurus Property-2)
C0205447 (UMLS 2011AA Property-2)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)

ChemotherapyRegimenOneReceiveBeginDate

Item

Start date for Regimen 1:

date

C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C66832 (NCI Thesaurus Property-2)
C0205447 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)

ChemotherapyRegimenOneReceiveEndDate

Item

End date for Regimen 1:

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C66832 (NCI Thesaurus Property-2)
C0205447 (UMLS 2011AA Property-2)
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)

ChemotherapyRegimenReceiveChemotherapyRegimenReceiveType

Item

How many prior cytotoxic chemotherapy regimens has the patient received?

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)

CL.23

Code List

How many prior cytotoxic chemotherapy regimens has the patient received?

CL Item

No Chemotherapy Regimens (0 Regimens)

CL Item

One Chemotherapy Regimen (1 Regimen)

CL Item

Two Or More Chemotherapy Regimens (2 or more Regimens)

ChemotherapyRegimenTwoReceiveName

Item

Drug Regimen 2:

text

C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C66833 (NCI Thesaurus Property)
C0205448 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)

ChemotherapyRegimenTwoReceiveBeginDate

Item

Start date for Regimen 2:

date

C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C66833 (NCI Thesaurus Property)
C0205448 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)

ChemotherapyRegimenTwoReceiveEndDate

Item

End date for Regimen 2:

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C66833 (NCI Thesaurus Property)
C0205448 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionTherapeuticProcedureReceiveInd-2

Item

Has the patient received any non-cytotoxic chemotherapy for management of recurrent or persistent disease

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C17747 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C25639 (NCI Thesaurus Property-4)
C1514756 (UMLS 2011AA Property-4)
C49236 (NCI Thesaurus Property-5)
C0087111 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

LaboratoryProcedureEvaluationOutcomeDate

Item

Date of Results (if more than one, enter earliest:)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2

Item

Platelets greater than or equal to 100,000/mcl?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C51951 (NCI Thesaurus Property)
C0032181 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)

LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2

Item

ANC greater than or equal to 1,500/mcl?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)

LaboratoryProcedureCreatinineUpperLimitofNormalOutcomeInd-2

Item

Is the creatinine less than or equal to 1.5 X ULN

boolean

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)
C25706 (NCI Thesaurus Property-3)
C1519815 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientElevatedBilirubinPersonalMedicalHistoryInd-2

Item

Is the bilirubin less than or equal to 1.5 x ULN (regardless of the presence of liver metastases)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27088 (NCI Thesaurus Property)
C0311468 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)

SerumGlutamicPyruvateTransaminasesHepaticWithinProtocolUpperLimitofNormalLabInd-2

Item

Is SGPT (ALT) less than or equal to 3.0 X Upper Limits of Normal

boolean

C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25293 (NCI Thesaurus ObjectClass-2)
C0376147 (UMLS 2011AA ObjectClass-2)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C25282 (NCI Thesaurus Property-3)
C0332285 (UMLS 2011AA Property-3)
C25706 (NCI Thesaurus Property-4)
C1519815 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

LaboratoryProcedureAlkalinePhosphataseEligibilityDeterminationInd-2

Item

Is the alkaline phosphatase less than or equal to 2.5 x ULN? (regardless of the presence of liver metastases)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)

PersonCreatinineUrineProteinMeasurementClinicalTrialEligibilityCriteriaInd-2

Item

Is her urine protein creatinine (UPC) ratio less than 1 (or urinary protein less than 1.0g/24 hours)

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C74760 (NCI Thesaurus Property-3)
C0262923 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

LaboratoryProcedureProthrombinTimeResultProthrombinTimeType

Item

Is the Prothrombin Time (PT) such that the International Normalized Ratio (INR) is:

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C62656 (NCI Thesaurus Property-2)
C0033707 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

CL.33

Code List

Is the Prothrombin Time (PT) such that the International Normalized Ratio (INR) is:

CL Item

Less Than Or Equal To 1.5 X Uln (Less than or equal to 1.5 x ULN)

CL Item

Between 2 And 3 And On A Stable Dose Of Therapeutic Warfarin (Between 2 and 3 AND on a stable dose of therapeutic warfarin)

CL Item

Greater Than 3 (Greater than 3)

LaboratoryProcedurePartialThromboplastinTimeResultInd-2

Item

Is the PTT less than or equal to 1.5 times the institutional upper limit of normal?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38462 (NCI Thesaurus Property-2)
C0030605 (UMLS 2011AA Property-2)

ElectrocardiographyDiagnosticProcedureQTcIntervalAssessmentInd-2

Item

Has the patient had a baseline electrocardiogram completed within 28 days prior to study entry and was the QTc found to be less than or equal to 450 msec? (ventricular tachycardia must be less than 3 beats in a row or ventricular fibrillation)

boolean

C38053 (NCI Thesaurus ObjectClass)
C1623258 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass-2)
C0430022 (UMLS 2011AA ObjectClass-2)
C25367 (NCI Thesaurus Property)
C0489625 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientEligibilityInd-2

Item

Has the patient met the pre-entry requirements as specified in section 7.0

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)

PatientNegativePregnancyTestInd-4

Item

If the patient has childbearing potential, has she had a negative serum pregnancy test within 14 days prior to initiation protocol therapy

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
C49486 (NCI Thesaurus ValueDomain)
C1704854 (UMLS 2011AA ValueDomain)

CL.37

Code List

If the patient has childbearing potential, has she had a negative serum pregnancy test within 14 days prior to initiation protocol therapy

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

ContraceptionAgreementInd

Item

If patient has the capacity to become pregnant, has she agreed to use adequate contraception (two barrier methods of birth control) prior to study entry and for the duration of the study and up to three months after the final dose of BIBF1120?

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C37932 (NCI Thesaurus ObjectClass)
C0700589 (UMLS 2011AA ObjectClass)
C25369 (NCI Thesaurus Property)
C0680240 (UMLS 2011AA Property)

CL.38

Code List

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

PersonPriorAntiangiogenesisTherapyClinicalTrialEligibilityCriteriaInd-2

Item

Has the patient received prior therapy with BIBF1120?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C15568 (NCI Thesaurus Property-3)
C0281318 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientNeoplasmPersonalMedicalHistoryIndicator

Item

Has the patient had another invasive malignancy other than non-melanoma of the skin, localized cancer of the breast, head and neck or skin diagnosed, present or recur within the past 3 years?

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)

PersonPriorRadiationTherapyAbdominalCavityPelvisClinicalTrialEligibilityCriteriaInd-2

Item

Has the patient received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of endometrial cancer within the last three years?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C12664 (NCI Thesaurus Property-2)
C0230168 (UMLS 2011AA Property-2)
C12767 (NCI Thesaurus Property-3)
C0030797 (UMLS 2011AA Property-3)
C25629 (NCI Thesaurus Property-4)
C0332152 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonPriorRadiationTherapyBreastHeadandNeckSkinClinicalTrialEligibilityCriteriaInd-2

Item

Has the patient received prior radiation for localized cancer of the breast, head and neck or skin?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C12470 (NCI Thesaurus Property-2)
C1123023 (UMLS 2011AA Property-2)
C12971 (NCI Thesaurus Property-3)
C0006141 (UMLS 2011AA Property-3)
C12418 (NCI Thesaurus Property-4)
C0460004 (UMLS 2011AA Property-4)
C25629 (NCI Thesaurus Property-5)
C0332152 (UMLS 2011AA Property-5)
C16112 (NCI Thesaurus Property-6)
C1516637 (UMLS 2011AA Property-6)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonPriorRadiationTherapyBreastHeadandNeckSkinNoCancerProgressionClinicalTrialEligibilityCriteriaInd-4

Item

Was the prior radiation for localized cancer of the breast, head and neck or skin completed more than 3 years prior to registration and does the patient remain free of recurrent or metastatic disease?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C15313 (NCI Thesaurus Property-2)
C1522449 (UMLS 2011AA Property-2)
C12470 (NCI Thesaurus Property-3)
C1123023 (UMLS 2011AA Property-3)
C12971 (NCI Thesaurus Property-4)
C0006141 (UMLS 2011AA Property-4)
C12418 (NCI Thesaurus Property-5)
C0460004 (UMLS 2011AA Property-5)
C25629 (NCI Thesaurus Property-6)
C0332152 (UMLS 2011AA Property-6)
C19987 (NCI Thesaurus Property-7)
C0242656 (UMLS 2011AA Property-7)
C16112 (NCI Thesaurus Property-8)
C1516637 (UMLS 2011AA Property-8)
C49486 (NCI Thesaurus ValueDomain)
C1704854 (UMLS 2011AA ValueDomain)

CL.43

Code List

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

PriorGynecologicChemotherapyAdministeredInd-2

Item

Has the patient received prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of endometrial cancer within the last three years?

boolean

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C28016 (NCI Thesaurus ObjectClass-3)
C0205480 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonPriorAdjuvantChemotherapyClinicalTrialEligibilityCriteriaInd-2

Item

Has the patient received prior adjuvant chemotherapy for localized breast cancer?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15360 (NCI Thesaurus Property)
C0085533 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonPriorAdjuvantChemotherapyNoCancerProgressionClinicalTrialEligibilityCriteriaInd-4

Item

Was the prior adjuvant chemotherapy for localized cancer of the breast completed more than 3 years prior to registration and does the patient remain free of recurrent or metastatic disease?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C15360 (NCI Thesaurus Property-2)
C0085533 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C19987 (NCI Thesaurus Property-4)
C0242656 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C49486 (NCI Thesaurus ValueDomain)
C1704854 (UMLS 2011AA ValueDomain)

CL.46

Code List

Was the prior adjuvant chemotherapy for localized cancer of the breast completed more than 3 years prior to registration and does the patient remain free of recurrent or metastatic disease?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

ReceivedTherapyProtocolContraindicatedInd-3

Item

Is the treatment of previous cancer a contraindication to the current protocol therapy?

boolean

C25639 (NCI Thesaurus ObjectClass)
C1514756 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C37933 (NCI Thesaurus Property-2)
C1444657 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

PatientWoundComplicationPersonalMedicalHistoryInd-3b

Item

Does the patient have a serious non-healing wound, ulcer or bone fracture?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3671 (NCI Thesaurus Property)
C0043250 (UMLS 2011AA Property)
C2959 (NCI Thesaurus Property-2)
C0009566 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)

PersonAbdominalCavityFistulaPerforationAbscessClinicalTrialEligibilityCriteriaInd-2

Item

Does the patient have a history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 28 days prior to first day of study therapy or an underlying lesion(s) that caused the fistula or perforation in the past that have not been corrected?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C12664 (NCI Thesaurus Property)
C0230168 (UMLS 2011AA Property)
C26686 (NCI Thesaurus Property-2)
C0549483 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C4080 (NCI Thesaurus Property-4)
C0549099 (UMLS 2011AA Property-4)
C3045 (NCI Thesaurus Property-5)
C0016169 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientHemorrhagePre-ExistingConditionInd-3b

Item

Does the patient have active bleeding or pathologic conditions that carry high risk of bleeding such as known bleeding disorder, coagulopathy or tumor involving major vessels?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C26791 (NCI Thesaurus Property)
C0019080 (UMLS 2011AA Property)
CL232826 (NCI Metathesaurus Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)

PatientCentralNervousSystemDiseaseorDisorderEligibilityDeterminationInd-2

Item

Does the patient have a history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus Property)
C3714787 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientCentralNervousSystemDiseaseorDisorderEligibilityDeterminationInd-2

Item

boolean

CardiovascularDiseasePresentInd-2

Item

Has the patient had clinically significant cardiovascular disease

boolean

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-2)
C0012634 (UMLS 2011AA ObjectClass-2)

PatientInadequateControlHypertensionExclusionCriteriaInd-2

Item

Does the patient have uncontrolled hypertension defined as systolic greater than 140 mm Hg or diastolic greater than 90 mm Hg despite anti-hypertensive therapy?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3117 (NCI Thesaurus Property)
C0020538 (UMLS 2011AA Property)
C61299 (NCI Thesaurus Property-2)
C2587213 (UMLS 2011AA Property-2)
C25370 (NCI Thesaurus Property-3)
C0680251 (UMLS 2011AA Property-3)
C69177 (NCI Thesaurus Property-4)
C0205412 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

MyocardialInfarctionPatientPreviousYearPersonalMedicalHistoryInd-2

Item

Has the patient had a myocardial infarction or unstable angina within 6 months of the first date of study therapy?

boolean

C27996 (NCI Thesaurus ObjectClass)
C0027051 (UMLS 2011AA ObjectClass)
C0030705 (NCI Metathesaurus ObjectClass)
C25627 (NCI Thesaurus Property)
C0205156 (UMLS 2011AA Property)
C29848 (NCI Thesaurus Property-2)
C0439234 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonNewYorkHeartAssociationClassIIClinicalTrialEligibilityCriteriaInd-2

Item

Using the New York Heart Association (NYHA) guideline, does the patient have Class II or greater congestive heart failure?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C66905 (NCI Thesaurus Property-2)
C1882085 (UMLS 2011AA Property-2)

PersonEjectionFractionLowerLimitofNormalClinicalTrialEligibilityCriteriaInd-2

Item

Does the patient have an ejection fraction of less than institutional LLN?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C25555 (NCI Thesaurus Property-3)
C1518030 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonVentricularArrhythmiaArrhythmiaMedicationClinicalTrialEligibilityCriteriaInd-2

Item

Does the patient have a history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation) or arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C2881 (NCI Thesaurus Property)
C0003811 (UMLS 2011AA Property)
C459 (NCI Thesaurus Property-2)
C0013227 (UMLS 2011AA Property-2)
E10230 (CTCAE Property)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CardiacDiseasePresentInd-2

Item

Does the patient have valvular heart disease greater than or equal to Grade 2?

boolean

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

PersonSurgicalProcedureInjuryEligibilityDeterminationInd-2

Item

Has the patient undergone a major surgical procedure, open biopsy or incurred a significant traumatic injury within 28 days prior to the first date of study therapy?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C3671 (NCI Thesaurus Property-2)
C0043250 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

GynecologicOncologyGroupMajorSurgeryInd-3b

Item

Is a major surgical procedure anticipated for this patient during the course of this study

boolean

C25521 (NCI Thesaurus ObjectClass)
C1512288 (UMLS 2011AA ObjectClass)
C0679637 (NCI Metathesaurus Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)

PatientCoreBiopsyMinorSurgicalProcedureExclusionCriteriaInd-2

Item

Has the patient had any minor surgical procedures, fine needle aspirates or core biopsies within 7 days prior to the first date of study therapy?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15680 (NCI Thesaurus Property)
C1318309 (UMLS 2011AA Property)
C15329 (NCI Thesaurus Property-2)
C0543467 (UMLS 2011AA Property-2)
C45367 (NCI Thesaurus Property-3)
C0205165 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonLegalAdolescentClinicalTrialEligibilityCriteriaInd-2

Item

Is the patient under age 18?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C27954 (NCI Thesaurus Property-2)
C0205653 (UMLS 2011AA Property-2)
C54074 (NCI Thesaurus Property-3)
C1301860 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientPregnancyInd-2

Item

Is the patient pregnant or nursing?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)

PersonThromboembolismPersonalMedicalHistoryInd-3

Item

Does the patient have a history of major thromboembolic event defined as: symptomatic pulmonary embolism (PE), recurrent asymptomatic PE, or recurrent deep vein thrombosis?

boolean

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)

PersonPriorThromboemboliceventInheritedCoagulationDisorderClinicalTrialEligibilityCriteriaInd-2

Item

Has the patient had prior thrombosis or thromboembolic event due to a known inherited coagulopathy? (ie, antithrombin-III deficiency, Protein C or Protein S deficiency, Factor V Leiden mutation presence, prothrombin G20210A mutation )

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
E13825 (CTCAE Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C2902 (NCI Thesaurus Property-3)
C0005779 (UMLS 2011AA Property-3)
C28018 (NCI Thesaurus Property-4)
C0439660 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientPriorDiseaseorDisorderSystemicAntibioticAntiviralTherapyEligibilityDeterminationInd-2

Item

Has the patient had serious infections requiring systemic antibiotics or antiviral therapy including: known active Hepatitis B or C infection; known HIV infection?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13310 (NCI Thesaurus Property)
C0205373 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C2991 (NCI Thesaurus Property-3)
C0012634 (UMLS 2011AA Property-3)
C258 (NCI Thesaurus Property-4)
C0003232 (UMLS 2011AA Property-4)
C25171 (NCI Thesaurus Property-5)
C0013893 (UMLS 2011AA Property-5)
C16119 (NCI Thesaurus Property-6)
C0280274 (UMLS 2011AA Property-6)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonPriorImmunomodulatingAgentClinicalTrialEligibilityCriteriaInd-2

Item

Has the patient been treated with immune modulators such as systemic cyclosporine or tacrolimus within 30 days prior to enrollment?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C308 (NCI Thesaurus Property-3)
C0005525 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonPriorPhotosensitivityClinicalTrialEligibilityCriteriaInd-2

Item

Does the patient have a history of photosensitivity or must she take agents which increase photosensitivity?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
E13680 (CTCAE Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientSwallowingAssessmentInd-2

Item

Does the patient have the ability to swallow oral medication

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38028 (NCI Thesaurus Property-2)
C0011167 (UMLS 2011AA Property-2)

TreatmentPlannedDate

Item

Anticipated date treatment will start

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)

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ClinicalTrialEligibilityCriteriaWorksheetCommentText

Item

Provide comments about this Fast Fact Sheet

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
C16112 (NCI Thesaurus ObjectClass)
C1516637 (UMLS 2011AA ObjectClass)
C73541 (NCI Thesaurus Property-2)
C2349155 (UMLS 2011AA Property-2)

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Endometrial Cancer NCT01225887 Pre-Study - GOG-0229K: Fast Fact Sheet for Protocol 0229-K (Endometrium) - 3183206v1.0

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