ID

8866

Beskrivning

GOG-0261: Fast Fact Sheet for Protocol 0261 (Uterine Corpus, Ovary) Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed Persistent or Recurrent Uterine or Ovarian Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=74E5BFDB-0F29-45AE-E040-BB89AD432FB0

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=74E5BFDB-0F29-45AE-E040-BB89AD432FB0

Nyckelord

Klinische Studie [Dokumenttyp]

Registration

D010051

2012-09-19 2012-09-19 -
2015-01-09 2015-01-09 - Martin Dugas
2015-01-09 2015-01-09 - Martin Dugas

Uppladdad den

9 januari 2015

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0 Legacy

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Ovarian Cancer NCT00954174 Registration - GOG-0261: Fast Fact Sheet for Protocol 0261 (Uterine Corpus, Ovary) - 2949744v1.0

model
Detaljer

No Instruction available.

1 Formulär

StudyEvent: GOG-0261: Fast Fact Sheet for Protocol 0261 (Uterine Corpus, Ovary)
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

This Patient's 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 Name, Last

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 Name, First

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 Name, Middle

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)

Social Security Number

Item

Patient Social Security Number

text

C25337 (NCI Thesaurus ValueDomain)
C1301821 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25686 (NCI Thesaurus Property)

PersonAddressPostalCode

Item

Patient Zip Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)

AddressCountryText

Item

Country

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25464 (NCI Thesaurus Property)
C0454664 (UMLS 2011AA Property)
C25407 (NCI Thesaurus ObjectClass)
C1442065 (UMLS 2011AA ObjectClass)

Racial Group

Item

Race

text

C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)

CL.1

Code List

Race

CL Item

A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)

C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)

CL Item

A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)

C41260 (NCI Thesaurus)
C0078988 (UMLS 2011AA)

CL Item

A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)

C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)

CL Item

A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)

C41219 (NCI Thesaurus)
C1513907 (UMLS 2011AA)

CL Item

Could Not Be Determined Or Unsure (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)

C41261 (NCI Thesaurus)
C0007457 (UMLS 2011AA)

Ethnic Group

Item

Ethnicity

text

C25372 (NCI Thesaurus ValueDomain)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)

CL.2

Code List

Ethnicity

CL Item

A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (Hispanic or Latino)

C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)

CL Item

A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)

C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)

CL Item

Could Not Be Determined Or Unsure (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientPaymentType

Item

Method of Payment

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)

CL.3

Code List

Method of Payment

CL Item

Medicaid (Medicaid)

C0025071 (NCI Metathesaurus)

CL Item

Medicaid And Medicare (Medicaid and Medicare)

CL Item

Medicare (Medicare)

C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)

CL Item

Medicare And Private Insurance (Medicare and Private Insurance)

CL Item

Military Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))

CL Item

Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))

CL Item

No Means Of Payment (no Insurance) (No means of payment (no insurance))

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Private Insurance (Private Insurance)

CL Item

Self Pay (no Insurance) (Self Pay (No Insurance))

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Veterans Sponsored (Veterans Sponsored)

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)

PatientAuthorizationConfidentialInformationInd-3

Item

Has the patient provided written authorization permitting release of personal health information

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
C0009668 (NCI Metathesaurus Property)

UterusOvaryCancerDiagnosisInd-2

Item

Does the patient have newly diagnosed Stage I-IV OR persistent OR recurrent (including unstaged), pathologically confirmed uterine or ovarian carcinosarcoma

boolean

C12404 (NCI Thesaurus ObjectClass)
C0029939 (UMLS 2011AA ObjectClass)
C12405 (NCI Thesaurus ObjectClass-2)
C0042149 (UMLS 2011AA ObjectClass-2)
C9305 (NCI Thesaurus ObjectClass-3)
C0006826 (UMLS 2011AA ObjectClass-3)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

UterusOvaryMalignantNeoplasmDiagnosisType

Item

Was the patient diagnosed with ovarian carcinosarcoma or uterine carcinosarcoma

text

C12404 (NCI Thesaurus ObjectClass)
C0029939 (UMLS 2011AA ObjectClass)
C12405 (NCI Thesaurus ObjectClass-2)
C0042149 (UMLS 2011AA ObjectClass-2)
C9305 (NCI Thesaurus ObjectClass-3)
C0006826 (UMLS 2011AA ObjectClass-3)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.7

Code List

Was the patient diagnosed with ovarian carcinosarcoma or uterine carcinosarcoma

CL Item

Ovarian (Ovarian)

CL Item

Uterus (Uterine)

C12405 (NCI Thesaurus)
C0042149 (UMLS 2011AA)

UterusSpecimenPathologicReviewInd-2

Item

Has there been a review of the pathologic specimen from the uterus or ovary

boolean

C12405 (NCI Thesaurus ObjectClass)
C0042149 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C42729 (NCI Thesaurus Property-2)
C1552617 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PriorUterineCarcinosarcomaChemotherapyNotAdministeredInd-2

Item

Is the patient chemotherapy naive as directed against uterine or ovarian carcinosarcoma

boolean

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C42700 (NCI Thesaurus ObjectClass-3)
C0280630 (UMLS 2011AA ObjectClass-3)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PriorAdjuvantExternalBeamRadiationTherapyVaginalBrachytherapyAdministeredInd-2

Item

Has the patient received prior adjuvant external beam radiation therapy and/or vaginal brachytherapy

boolean

C25722 (NCI Thesaurus ObjectClass)
C1522673 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15751 (NCI Thesaurus ObjectClass-3)
C1517033 (UMLS 2011AA ObjectClass-3)
C15195 (NCI Thesaurus Property)
C0006098 (UMLS 2011AA Property)
C13309 (NCI Thesaurus Property-2)
C0042232 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

RadiationTherapyCompleteIndicator

Item

Will the completion of the radiotherapy be at least 4 weeks prior to beginning protocol chemotherapy (If yes,)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)

CL.11

Code List

Will the completion of the radiotherapy be at least 4 weeks prior to beginning protocol chemotherapy (If yes,)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

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)

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.13

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)

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)

CL Item

Dead (5)

PatientRecoveryEligibilityInd-2

Item

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

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25746 (NCI Thesaurus Property)
C2004454 (UMLS 2011AA Property)

PatientNoInfectionInd-2

Item

Is the patient free of active infection requiring antibiotics

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C26726 (NCI Thesaurus Property-2)
C0009450 (UMLS 2011AA Property-2)

Eligibility 2

Item Group

Unnamed2

RecentEndocrineTherapyReceiveInd-2

Item

Has the patient received/will the patient receive any hormonal therapy directed at the malignant tumor within one week of beginning protocol chemotherapy (Continuation of hormone replacement therapy is permitted.)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25280 (NCI Thesaurus ObjectClass-2)
C0332185 (UMLS 2011AA ObjectClass-2)

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)

Platelets

Item

Platelets (must be 100,000/mcl or greater)

float

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

ANC

Item

ANC (must be 1,500/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)

LaboratoryProcedureCreatinineUpperLimitofNormalOutcomeInd-2

Item

Is the creatinine less than or equal to 1.5 X ULN (CTCAE v3.0 Grade 1)

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)

LaboratoryProcedureTotalBilirubinResultInd-2

Item

Is the bilirubin less than or equal to 1.5 X ULN (CTCAE v3.0 Grade 1)

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)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseUpperLimitofNormalResultInd-2

Item

Are SGOT and Alkaline Phosphatase less than or equal to 2.5 times institutional 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)

LaboratoryProcedureAlbuminResultInd-2

Item

Is the albumin greater than or equal to 3 g/dl

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C214 (NCI Thesaurus Property-2)
C0001924 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

CommonTerminologyCriteriaforAdverseEventsLowNeuropathyInd-2

Item

Is sensory or motor neuropathy less than or equal to CTCAE v 3.0 grade 1

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C54722 (NCI Thesaurus Property)
C0205251 (UMLS 2011AA Property)
C4731 (NCI Thesaurus Property-2)
C0031117 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)

PatientNegativePregnancyTestInd-4

Item

If the patient is of childbearing potential, has she had a negative serum pregnancy test within 72 hours prior to initiating protocol therapy and is she practicing an effective form of contraception

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.22

Code List

If the patient is of childbearing potential, has she had a negative serum pregnancy test within 72 hours prior to initiating protocol therapy and is she practicing an effective form of contraception

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PriorRTPelvicAdministeredInd-3

Item

Was the patient treated previously with pelvic or extended field radiation

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)

PatientUterineCarcinosarcomaStageGroupingClinicalTrialEligibilityCriteriaType

Item

What best describes the patient's disease status/stage at the time of study entry

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C42700 (NCI Thesaurus Property-2)
C0280630 (UMLS 2011AA Property-2)
C38027 (NCI Thesaurus Property-3)
C1519504 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.24

Code List

What best describes the patient's disease status/stage at the time of study entry

CL Item

Figo Clinical Stage I-ii (FIGO Clinical Stage I-II)

CL Item

Figo Surgical Stage I-ii, Pelvic Nodes Not Surgically/pathologically Assessed (FIGO Surgical Stage I-II, pelvic nodes not surgically/pathologically assessed)

CL Item

Figo Surgical Stage I-ii, Pelvic Nodes Are Surgically/pathologically Assessed (FIGO Surgical Stage I-II, pelvic nodes are surgically/pathologically assessed)

CL Item

Figo Surgical Or Clinical Stage Iii-iv (FIGO Surgical or Clinical Stage III-IV)

CL Item

Recurrence Or Disease That Persists After A 1st Line Regimen Without Chemo (Recurrence or disease that persists after a 1st line regimen without chemo)

RecurrentDiseaseDiagnosisDate

Item

Date recurrence or persistence was confirmed (If applicable,)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

AssessmentRecurrentDiseaseMethodType

Item

How was recurrence or persistence established for this study

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C38155 (NCI Thesaurus Property-2)
C0277556 (UMLS 2011AA Property-2)

CL.25

Code List

How was recurrence or persistence established for this study

CL Item

Histologic (Histologic)

C25526 (NCI Thesaurus)
C0205462 (UMLS 2011AA)
C25526 (NCI Thesaurus-3)
C0205462 (UMLS 2011AA-4)

CL Item

Non-histological Method (Non-Histological Method)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

PatientMeasurableDiseaseResponseEvaluationCriteriainSolidTumorsEligibilityDeterminationInd-2

Item

Does patient have measurable disease as defined by GOG RECIST criteria (Section 8.0 of the protocol)

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C8507 (NCI Thesaurus Property)
C1513041 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C49164 (NCI Thesaurus Property-3)
C1709926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

Eligibility 3

Item Group

Unnamed3

PriorCytotoxicChemotherapyUterineCarcinosarcomaAdministeredInd-2

Item

Has the patient received prior cytotoxic chemotherapy for management of uterine or ovarian sarcoma

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)
C42700 (NCI Thesaurus Property-2)
C0280630 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientNeoplasmPersonalMedicalHistoryInd-2

Item

Does the patient have a history of the presence of other invasive malignancies, other than non-melanoma skin cancer, within the past 5 years

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (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)

ConcurrentRadiationTherapyPriorCancerProgressionPlanInd-2

Item

Is radiotherapy planned after or during study chemotherapy prior to progression of cancer

boolean

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25456 (NCI Thesaurus ObjectClass-2)
C0205420 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25619 (NCI Thesaurus Property-2)
C1301732 (UMLS 2011AA Property-2)
C19987 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientEscherichiacoliDerivedMedicationSensitivityInd-2

Item

Does the patient have a known hypersensitivity to E. Coli-derived drug preparation (Pegfilgrastim and Filgrastim)

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C14206 (NCI Thesaurus Property)
C0014834 (UMLS 2011AA Property)
C459 (NCI Thesaurus Property-2)
C0013227 (UMLS 2011AA Property-2)
C25201 (NCI Thesaurus Property-3)
C1522640 (UMLS 2011AA Property-3)
C42885 (NCI Thesaurus Property-4)
C1441547 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientMesnaMedicationSensitivityInd-2

Item

Does the patient have a known hypersensitivity to mesna or other thiol compounds

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus Property)
C0013227 (UMLS 2011AA Property)
C25201 (NCI Thesaurus Property-2)
C1522640 (UMLS 2011AA Property-2)
C192 (NCI Thesaurus Property-3)
C0000294 (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 of initiating protocol chemotherapy (CBC, Differential, Platelets, Serum Creatinine, Urinanalysis, Bilirubin, DGOT, Alkaline Phosphatase, Electrolytes, BUN, Calcium, Magnesium, Phosphate and Albumin)

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, CA-125, Imaging of chest, pelvis and abdomen, EKG and Tumor Measurements radiographic or clinical)

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)

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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Ovarian Cancer NCT00954174 Registration - GOG-0261: Fast Fact Sheet for Protocol 0261 (Uterine Corpus, Ovary) - 2949744v1.0

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