ID

8914

Beskrivning

Fast Fact Sheet for Protocol 0258 (Endometrium) Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A5C0A0F9-00AC-D53F-E040-BB89AD43271E

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A5C0A0F9-00AC-D53F-E040-BB89AD43271E

Nyckelord

D016430

D016889

Registration

2014-12-18 2014-12-18 - Martin Dugas
2015-01-09 2015-01-09 - Martin Dugas

Uppladdad den

9 januari 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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Endometrial Cancer NCT00942357 Pre-Study - Fast Fact Sheet for Protocol 0258 (Endometrium) - 3244339v1.0

model
Detaljer

No Instruction available.

1 Formulär

StudyEvent: Fast Fact Sheet for Protocol 0258 (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)

PersonFirstIMRTInstitutionRecipientInd-3b

Item

Is this the first patient to receive IMRT on this study (GOG 0258) from your Institution?

text

CL.18

Code List

Is this the first patient to receive IMRT on this study (GOG 0258) from your Institution?

CL Item

Yes (Yes)

CL Item

No (No)

CL Item

Not Applicable (Not Applicable)

TreatmentPlanFirstIMRTInstitutionRecipientSubmissionInd-3b

Item

Will the treatment plan for this first patient to be treated at your institution be digitally submitted to the ITC for processing in preparation for the rapid review?

text

CL.19

Code List

Will the treatment plan for this first patient to be treated at your institution be digitally submitted to the ITC for processing in preparation for the rapid review?

CL Item

Yes (Yes)

CL Item

Not Applicable (Not Applicable)

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)

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.3

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.4

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

Adenocarcinoma W/ Squamous Differentiation (Adenocarcinoma w/ Squamous Differentiation)

CL Item

Adenosquamous Carcinoma (Adenosquamous Carcinoma)

C3727 (NCI Thesaurus)
C0206623 (UMLS 2011AA)

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

Small Cell Carcinoma (Small Cell Carcinoma)

C3915 (NCI Thesaurus)
C0262584 (UMLS 2011AA)

CL Item

Undifferentiated Carcinoma (Undifferentiated Carcinoma)

C3692 (NCI Thesaurus)
C0205698 (UMLS 2011AA)

CL Item

Villoglandular Carcinoma (Villoglandular carcinoma)

GynecologicTumorHistologicGrade

Item

What is 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.5

Code List

What is 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)

CL Item

Not Graded (Not Graded)

GynecologicTumorGroupingFIGO2009EndometrialCarcinomaStage

Item

Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass-2)
C0205480 (UMLS 2011AA ObjectClass-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C25523 (NCI Thesaurus Property)
C1522242 (UMLS 2011AA Property)

CL.6

Code List

Stage

CL Item

Stage I (I)

CL Item

Stage Ii (II)

CL Item

Stage Iii (III)

CL Item

Stage Iva (IVA)

PersonEndometrialMetastaticMalignantNeoplasmAdnexalMassEligibilityDeterminationInd-3b

Item

Positive Adnexa (For patients with Surgical Stage III disease, please indicate the areas of involvement at least one must be Yes - answer Yes to all that apply:)

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C13322 (NCI Thesaurus Property-2)
C0227843 (UMLS 2011AA Property-2)
C36263 (NCI Thesaurus Property-3)
C2939419 (UMLS 2011AA Property-3)
C35155 (NCI Thesaurus Property-4)
C0149614 (UMLS 2011AA Property-4)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)

CL.7

Code List

Positive Adnexa (For patients with Surgical Stage III disease, please indicate the areas of involvement at least one must be Yes - answer Yes to all that apply:)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

PersonEndometrialMetastaticMalignantNeoplasmSerosaEligibilityDeterminationInd-3b

Item

Tumor involves the serosa

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C13322 (NCI Thesaurus Property-2)
C0227843 (UMLS 2011AA Property-2)
C36263 (NCI Thesaurus Property-3)
C2939419 (UMLS 2011AA Property-3)
C13169 (NCI Thesaurus Property-4)
C0036760 (UMLS 2011AA Property-4)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)

CL.8

Code List

Tumor involves the serosa

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

PersonEndometrialMetastaticMalignantNeoplasmPelvicLymphNodeEligibilityDeterminationInd-3b

Item

Positive pelvic nodes

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C12363 (NCI Thesaurus Property)
C0729595 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C13322 (NCI Thesaurus Property-3)
C0227843 (UMLS 2011AA Property-3)
C36263 (NCI Thesaurus Property-4)
C2939419 (UMLS 2011AA Property-4)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)

CL.9

Code List

Positive pelvic nodes

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

PersonEndometrialMetastaticMalignantNeoplasmParaaorticLymphNodeEligibilityDeterminationInd-3b

Item

Positive para-aortic nodes

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C13322 (NCI Thesaurus Property-2)
C0227843 (UMLS 2011AA Property-2)
C36263 (NCI Thesaurus Property-3)
C2939419 (UMLS 2011AA Property-3)
C77643 (NCI Thesaurus Property-4)
C0229789 (UMLS 2011AA Property-4)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)

CL.10

Code List

Positive para-aortic nodes

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

PersonEndometrialMetastaticMalignantNeoplasmVaginaEligibilityDeterminationInd-3b

Item

Vaginal involvement

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C12407 (NCI Thesaurus Property)
C0042232 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C13322 (NCI Thesaurus Property-3)
C0227843 (UMLS 2011AA Property-3)
C36263 (NCI Thesaurus Property-4)
C2939419 (UMLS 2011AA Property-4)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)

CL.11

Code List

Vaginal involvement

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

PersonEndometrialMetastaticMalignantNeoplasmParametriumEligibilityDeterminationInd-3b

Item

Parametrial involvement

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C12320 (NCI Thesaurus Property)
C0227822 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C13322 (NCI Thesaurus Property-3)
C0227843 (UMLS 2011AA Property-3)
C36263 (NCI Thesaurus Property-4)
C2939419 (UMLS 2011AA Property-4)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)

CL.12

Code List

Parametrial involvement

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

PatientEndometrialMalignantNeoplasmEligibilityDeterminationInd-3b

Item

Does the patient have FIGO 2009 Surgical Stage I or II endometrial clear cell or serous carcinoma with positive peritoneal cytology?

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C13322 (NCI Thesaurus Property-3)
C0227843 (UMLS 2011AA Property-3)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)

CL.13

Code List

Does the patient have FIGO 2009 Surgical Stage I or II endometrial clear cell or serous carcinoma with positive peritoneal cytology?

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)

PrimaryTumorDiagnosisDate

Item

Date primary confirmed (Please report date of surgical staging. This date must be less than or equal to 8 weeks from today)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

BilateralOophorectomyPerformedInd-2

Item

Has the patient had a hysterectomy and bilateral salpingo-oophorectomy?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C13332 (NCI Thesaurus ObjectClass)
C0238767 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15291 (NCI Thesaurus ObjectClass-2)
C0029936 (UMLS 2011AA ObjectClass-2)

GrossResidualMalignantNeoplasmSurgicalProcedurePerformedInd-2

Item

Does the patient have residual tumor after surgery (any single site) exceeding 2 cm in maximum dimension?

boolean

C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C37895 (NCI Thesaurus ObjectClass-3)
C1609982 (UMLS 2011AA ObjectClass-3)
C43566 (NCI Thesaurus ObjectClass-4)
C0439806 (UMLS 2011AA ObjectClass-4)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

RadiationOncologistPersonIdentifierName

Item

Treating radiation oncologist (who has completed a Knowledge Assessment Questionnaire)

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17833 (NCI Thesaurus ObjectClass-2)
C1514693 (UMLS 2011AA ObjectClass-2)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

PersonExternalBeamRadiationTherapyPlanType

Item

What type of external beam radiation is planned in the event that Regimen I is assigned to the patient?

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15751 (NCI Thesaurus Property)
C1517033 (UMLS 2011AA Property)
C25619 (NCI Thesaurus Property-2)
C1301732 (UMLS 2011AA Property-2)

CL.16

Code List

What type of external beam radiation is planned in the event that Regimen I is assigned to the patient?

CL Item

Imrt (IMRT)

CL Item

3-dimensional Conformal Radiation Therapy (3D Conformal)

C16035 (NCI Thesaurus)
C0600521 (UMLS 2011AA)

RadiationTherapyIMRTIMRTCredentialInstitutionInd-4

Item

Has the treating Institution been credentialed for IMRT by the Radiological Physics Center (RPC) at M.D. Anderson Cancer Center?

text

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C16135 (NCI Thesaurus Property)
C1512814 (UMLS 2011AA Property)
C41206 (NCI Thesaurus Property-2)
C1272753 (UMLS 2011AA Property-2)
C73925 (NCI Thesaurus Property-3)
C2362313 (UMLS 2011AA Property-3)
C49486 (NCI Thesaurus ValueDomain)
C1704854 (UMLS 2011AA ValueDomain)

CL.17

Code List

Has the treating Institution been credentialed for IMRT by the Radiological Physics Center (RPC) at M.D. Anderson Cancer Center?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

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)

Leukocytes (WBC)

Item

WBC (must be 3,000 cells/mcl or greater)

float

C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)

ANC

Item

ANC (must be 1,500 cells/mcl or greater )

float

C25294 (NCI Thesaurus ObjectClass)
C0948762 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

Platelets

Item

Platelet count (must be 100,000/mcl or greater)

float

C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureCreatinineResultInd-2

Item

Is the Serum Creatinine less than or equal to institutional ULN?

boolean

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

PatientElevatedBilirubinPersonalMedicalHistoryInd-2

Item

Is the bilirubin less than or equal to 1.5 x ULN

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)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseUpperLimitofNormalResultInd-2

Item

Are the SGOT, SGPT and Alkaline Phosphatase less than or equal to 2.5 X ULN?

boolean

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25706 (NCI Thesaurus Property-3)
C1519815 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

LaboratoryProcedurePriorTherapeuticProcedurePerformedInd-2

Item

Will the patient have the following parameters measured within 14 days prior to initiating protocol therapy (HGB or HCT, ANC, Differential, Platelets, Creatinine, Bilirubin, SGOT, SGPT, Alkaline Phosphatase, Urinalysis and Quality of Life Assessment)

boolean

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C49236 (NCI Thesaurus Property-3)
C0087111 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PhysicalExaminationPriorTherapeuticProcedurePerformedInd-2

Item

Will the patient have the following parameters measured within 28 days prior to initiating protocol therapy (History and Physical Exam, Toxicity Assessment, Pelvic Examination, Chest X-Ray, Abdominal/Pelvi CT and if required a Chest CT scan)

boolean

C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C49236 (NCI Thesaurus Property-3)
C0087111 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientProtocolRequirementEligibilityDeterminationInd-2

Item

Do the testing values/results meet the eligibility criteria as specified in Section 3.1?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C42651 (NCI Thesaurus Property)
C0442711 (UMLS 2011AA Property)
C25652 (NCI Thesaurus Property-2)
C1514873 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
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)

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.27

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)

PatientAgeInd-2

Item

Is the patient age 18 years or older

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)

PersonCarcinosarcomaDiagnosisEligibilityDeterminationInd-2

Item

Does the patient have a diagnosis of carcinosarcoma?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C34448 (NCI Thesaurus Property)
C0007140 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientRecurrentEndometrialMalignantNeoplasmEligibilityDeterminationInd-2

Item

Does the patient have recurrent endometrial cancer

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C14173 (NCI Thesaurus Property-2)
C2945760 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C13322 (NCI Thesaurus Property-4)
C0227843 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PriorRTPelvicAdministeredInd-3

Item

Has the patient received prior radiotherapy to any portion of the abdominal cavity or pelvis

boolean

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25399 (NCI Thesaurus Property)
C0030797 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

PatientNeoplasmPersonalMedicalHistoryIndicator

Item

Does the patient have a history of invasive cancer other than non-melanoma skin cancer that has been active within the last 5 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)

ReceivedTherapyProtocolContraindicatedInd-3

Item

Has the patient had previous cancer treatment which contraindicates this 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)

PatientSeriousConcomitantDiseaseorDisorderEligibilityDeterminationInd-2

Item

Does the patient have a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C54035 (NCI Thesaurus Property-3)
C0205404 (UMLS 2011AA Property-3)
C25730 (NCI Thesaurus Property-4)
C0521115 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonSurvivalEligibilityDeterminationInd-2

Item

Does the patient have an estimated survival of less than 3 months?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C17177 (NCI Thesaurus Property-2)
C0038952 (UMLS 2011AA Property-2)

PatientEndometrialMalignantNeoplasmEligibilityDeterminationInd-2

Item

Does the patent have FIGO 2009 Stage IVB endometrial cancer?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C13322 (NCI Thesaurus Property-3)
C0227843 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

MyocardialInfarctionPatientPreviousYearPersonalMedicalHistoryInd-2

Item

Does the patient have a history of myocardial infarction, unstable angina or uncontrolled arrythmia within 3 months of enrollment?

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)

PersonParenchymaLiverMetastasisEligibilityDeterminationInd-2

Item

Does the patient have parenchymal liver metastases?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C12392 (NCI Thesaurus Property)
C0023884 (UMLS 2011AA Property)
C19151 (NCI Thesaurus Property-2)
C0027627 (UMLS 2011AA Property-2)
C74601 (NCI Thesaurus Property-3)
C0933845 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PriorGynecologicChemotherapyAdministeredInd-2

Item

Has patient received prior chemotherapy for endometrial cancer?

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)

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)

Provide comments about this Fast Fact Sheet

Item Group

Comments

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 NCT00942357 Pre-Study - Fast Fact Sheet for Protocol 0258 (Endometrium) - 3244339v1.0

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