ID

43383

Description

NSABP PROTOCOL C-08: REGISTRATION FORM Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer NCT00096278 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D7F6865F-B506-428D-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D7F6865F-B506-428D-E034-0003BA12F5E7

Keywords

Colorectal Neoplasms

Clinical Trial

Registration

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Colon cancer (NSABP C-08 NCT00096278)

model
Details

Refer to patient entry guidelines in the Members' Area of the NSABP Web site.

1 forms

StudyEvent: NSABP PROTOCOL C-08: REGISTRATION FORM
1. Refer to patient entry guidelines in the Members' Area of the NSABP Web site.

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Header

Item Group

Header

Patient ID NSABP

Item

NSABP Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)

Medical Record Number

Item

Patient Medical Record Number

text

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

Institution Name

Item

Institution Name

text

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

Institution Number

Item

Institution Number

text

C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)

Affiliate Name

Item

Affiliate Name

text

C21541 (NCI Thesaurus ObjectClass)
C1510825 (UMLS CUI-1)
C25413 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)

Investigator Name

Item

Physician of Record (physician to whom subsequent vials will be sent must have a valid FDA number)

text

C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)

InformedConsentFormSignedDate

Item

Date Informed Consent Signed (Month Day Year)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)

Person Completing Form Last Name

Item

Person Completing Form Last Name

text

C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1301584 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)

Person Completing Form First Name

Item

Person Completing Form First Name

text

C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1443235 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)

Person Completing Form Phone

Item

Person Completing Form Phone

text

C25337 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI-2)
C25657 (NCI Thesaurus ObjectClass-2)
C25395 (NCI Thesaurus Property)

ResponsiblePersonFaxNumber

Item

Person Completing Form Fax

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C1273518 (UMLS 2011AA ObjectClass-2)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)

Patient Initials

Item

Patient Initials (Last, First Middle)

text

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

PatientSocialSecurityNumber

Item

Patient Social Security Number (USA only)

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

Racial Group

Item

Race (more than one may be marked)

text

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

CL.1

Code List

Race (more than one may be marked)

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)

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)

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 Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment (American Indian or Alaska Native)

CL Item

Patient Is Unsure Of Their Race (Unknown)

PatientPaymentType

Item

Method of Payment (mark primary method only)

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.2

Code List

Method of Payment (mark primary method only)

CL Item

Private Insurance (Private Insurance)

CL Item

Medicare (Medicare)

C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)

CL Item

Medicare And Private Insurance (Medicare & Private)

CL Item

Medicaid (Medicaid)

C0025071 (NCI Metathesaurus)

CL Item

Medicaid And Medicare (Medicaid & Medicare)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Military Or Veterans Sponsored Nos (Military or Veterans Sponsored NOS)

CL Item

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

CL Item

Veterans Sponsored (Veterans Sponsored)

CL Item

Self Pay (no Insurance) (Self pay (no insurance))

CL Item

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

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientEthnicityCategory

Item

Ethnicity

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C29933 (NCI Thesaurus Property)

CL.3

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)

CL Item

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

C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)

CL Item

Patient Is Unsure Of Their Ethnicity (Unknown)

PatientAddressCountryCode

Item

Country of Residence (if not USA)

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)

CL.4

Code List

Country of Residence (if not USA)

CL Item

Canada (Canada)

C16380 (NCI Thesaurus)
C0006823 (UMLS 2011AA)

CL Item

Australia (Australia)

C16311 (NCI Thesaurus)
C0004340 (UMLS 2011AA)

CL Item

Mexico (Mexico)

C16850 (NCI Thesaurus)
C0025885 (UMLS 2011AA)

CL Item

Other (Other)

CL Item

Puerto Rico (Puerto Rico)

C17043 (NCI Thesaurus)
C0034044 (UMLS 2011AA)

PatientAddressPostalCode

Item

Patient's Zip Code (USA)

text

PerformanceStatusScale

Item

Performance Status

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25361 (NCI Thesaurus ObjectClass)
C0597198 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.5

Code List

Performance Status

CL Item

0 (Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90-100))

CL Item

1 (Restricted in physically strenuous activity but ambulatory (K 70-80))

CL Item

2 (Ambulatory and capable of all selfcare but unable to carry out any work activities (K 50-60))

CL Item

3 (Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours (K 30-40))

CL Item

4 (Completely disabled (K 10-20))

CL Item

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction (karnofsky 90 - 100) (ecog - 0 Asymptomatic) (0)

CL Item

Restricted In Physically Strenuous Activity But Ambulatory (k70 - 80) (ecog - 1 Symptomatic - Fully Ambulatory) (1)

CL Item

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities (k 50 - 60) (ecog - 2 Symptomatic; In Bed , 50% Of The Day) (2)

CL Item

Capable Of Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (k 30 - 40) (ecog - 3 Symptomatic; In Bed > 50% Of The Day But Not Bedridden) (3)

CL Item

Completely Disabled (k10 - 20) (ecog - 4 Bedridden) (4)

Patient characteristics

Item Group

Patient characteristics

C0815172 (UMLS CUI-1)

Patient Height

Item

Patient Height (cm)

float

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

Patient Weight

Item

Patient Weight (kg)

float

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

Gender

Item

Patient Gender

text

C25372 (NCI Thesaurus ValueDomain)
C0079399 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)

CL.6

Code List

Patient Gender

CL Item

Male (Male)

C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)

CL Item

Female (Female)

C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)

Birth Date

Item

Patient's Date of Birth (Month Day Year)

date

C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)

Surgery Date

Item

Date of Surgery (Month Day Year)

date

C25164 (NCI Thesaurus ValueDomain)
C1628561 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C15329 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)

TreatmentPlannedDate

Item

Date of Proposed Treatment (Month Day Year)

date

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

LymphNodeExaminedCount

Item

Lymph Nodes Number Examined

float

C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

LymphNodePositiveCount

Item

Lymph Nodes Number Positive

float

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

BloodPressure,Systolic

Item

Blood Pressure Systolic (Report the Most Recent Blood Pressure)

float

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)

Bloodpressure,Diastolic

Item

Blood Pressure Diastolic (Report the Most Recent Blood Pressure)

text

C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25299 (NCI Thesaurus ObjectClass)
C0428883 (UMLS 2011AA ObjectClass)

Menopausal status

Item

Menopausal status (Females only)

integer

C16960 (NCI Thesaurus ObjectClass)
C3231 (NCI Thesaurus Property)
C25688 (NCI Thesaurus ValueDomain)
C0455962 (UMLS CUI-1)

CL.8

Code List

Menopausal status (Females only)

CL Item

Postmenopausal (1)

C0232970 (UMLS CUI-1)

CL Item

Premenopausal (2)

C0232969 (UMLS CUI-1)

Creatinine

Item

Serum Creatinine Patient Value

float

C16960 (NCI Thesaurus ObjectClass)
C13325 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C0201976 (UMLS CUI-1)

Creatinine, serum ULN

Item

Serum Creatinine Upper Limit of Lab Normal (mg/dL)

float

C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)

UrinaryCreatinineProteinAssessmentValue

Item

Urine Protein/Creatinine Ratio

float

C25711 (NCI Thesaurus ObjectClass)
C1524119 (UMLS 2011AA ObjectClass)
C17021 (NCI Thesaurus ObjectClass-2)
C0033684 (UMLS 2011AA ObjectClass-2)
C0010294 (NCI Metathesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

Laboratory Procedure Date

Item

Date of Measurement (month day year)

date

C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)

UrinaryProteinCollectionValue

Item

Protein from 24 hour Urine Collection (g)

float

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

Tissue donor for cancer research

Item

Your blood and tissue samples may be kept by the NSABP for use in this study and future research to learn about, prevent, detect, or treat cancer.

boolean

C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C9305 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C0040288 (UMLS CUI-1)
C1516225 (UMLS CUI-2)

Tissue donor for research

Item

Your blood and tissue samples may be used for research about other health problems (for example: causes of heart disease, osteoporosis, diabetes).

boolean

C16960 (NCI Thesaurus ObjectClass)
C17649 (NCI Thesaurus Property)
C2991 (NCI Thesaurus Property-2)
C15206 (NCI Thesaurus Property-3)
C25460 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0040288 (UMLS CUI-1)
C0242481 (UMLS CUI-2)

Consent to contact patient

Item

Your study doctor (or someone he or she chooses) may contact you in the future to ask you to take part in more research.

boolean

C16960 (NCI Thesaurus ObjectClass)
C67527 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C16452 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1511481 (UMLS CUI-1)
C2051501 (UMLS CUI-2)

Consent to collect blood

Item

Your blood samples may be collected and sent to Genetech, Inc. for bevacizumab antibody testing.

boolean

C38147 (NCI Thesaurus ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus Property)
C25453 (NCI Thesaurus Property-2)

Eligibility Checklist

Item Group

C-08 Eligibility Checklist

C0013893 (UMLS CUI-1)

PatientStudyRequirementInd-2

Item

Does the patient have psychiatric or addictive disorders that would preclude the patient from meeting the study requirements?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)

PatientPHIConsentIndicator

Item

Has the patient authorized the release of Protected Health Information to the NSABP?

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)

Informed Consent

Item

Has the patient consented to participate in this study and signed and dated an approved consent form?

boolean

C0021430 (UMLS CUI-1)

OtherPatientColonTumorInd-2

Item

Does the patient have a colon tumor that is other than adenocarcinoma?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
CL053268 (NCI Metathesaurus Property)

Abdominal metastases

Item

Were there any isolated, distant, or non-contiguous intra-abdominal metastases (other than regional lymph nodes)?

boolean

C38148 (NCI Thesaurus ValueDomain)
C25626 (NCI Thesaurus Property)
C12664 (NCI Thesaurus ObjectClass)
C19151 (NCI Thesaurus Property-2)
C0854198 (UMLS CUI-1)

EnBlocResectionTumorCompleteInd-2

Item

Did the patient have an en bloc complete gross resection of tumor by open laparotomy or laparoscopically-assisted colectomy, i.e., curative resection?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C15232 (NCI Thesaurus ObjectClass)
C0728940 (UMLS 2011AA ObjectClass)

SystemicTherapyColorectalCarcinomaPerformedInd-2

Item

Has the patient received any systemic therapy or surgery (other than a decompressive colostomy or en bloc resection of tumor) for the current colon cancer?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C2955 (NCI Thesaurus Property-2)
C0009402 (UMLS 2011AA Property-2)

ColonTumorDistanceAnalVergeInd-2

Item

Is the distal extent of the lowest lying colon tumor greater or equal to 12 cm from the anal verge?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25419 (NCI Thesaurus Property)
C0227423 (UMLS 2011AA Property)

TumorHistologicallyConfirmedInd-2

Item

Does the patient have a histologically confirmed Stage II (T3, 4 N0 M0) or Stage III (any T N1,2 M0) tumor?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)

Liver function

Item

Is there postoperative evidence of adequate hepatic function as described in the protocol?

boolean

C38147 (NCI Thesaurus ValueDomain)
C12392 (NCI Thesaurus ObjectClass)
C25518 (NCI Thesaurus Property)
C0232741 (UMLS CUI-1)

LaboratoryProcedurePost-OperativePlateletNormalResultInd-2

Item

Are the postoperative absolute granulocyte count and platelet count within the criteria set by the protocol?

boolean

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C14165 (NCI Thesaurus Property)
C0205307 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C12520 (NCI Thesaurus Property-3)
C0005821 (UMLS 2011AA Property-3)
C25623 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientCoagulationBloodInd-2

Item

Is the patient's PT (INR) within the criteria set by the protocol?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)

NeuropathyAdverseEventToxicityInd-2

Item

Does the patient have significant peripheral neuropathy defined in the NCI CTCAE v3.0 as a grade 2 or greater neurosensory or neuromotor toxicity?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C27990 (NCI Thesaurus Property)
C0600688 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)

Major surgery

Item

Has the patient had a major surgical procedure, open biopsy or significant traumatic injury within 28 days of entry, or is there anticipation of a need for major surgical procedure during the course of the study?

boolean

C25190 (NCI Thesaurus ObjectClass)
C15329 (NCI Thesaurus Property)
C3671 (NCI Thesaurus Property-2)
C25171 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0679637 (UMLS CUI-1)

Uncontrolled hypertension

Item

Does the patient have uncontrolled hypertension?

boolean

C38148 (NCI Thesaurus ValueDomain)
C25626 (NCI Thesaurus Property)
C3117 (NCI Thesaurus ObjectClass)
C48932 (NCI Thesaurus ObjectClass-2)
C1868885 (UMLS CUI-1)

Prior neoplasm

Item

Has the patient had any prior malignancies in the past 5 years other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the colon or rectum, or carcinoma in situ of the cervix that has been effectively treated?

boolean

C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C3262 (NCI Thesaurus Property)
C18772 (NCI Thesaurus Property-2)
C0455471 (UMLS CUI-1)

heart failure

Item

Does the patient have Class III or Class IV cardiac disease or symptomatic arrhythmia

boolean

C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
C7922 (NCI Thesaurus Property-2)
C0278962 (UMLS CUI-1)

history of Coronary artery disease

Item

Does the patient have a history of myocardial infarction or unstable angina within the past 12 months

boolean

C27996 (NCI Thesaurus ObjectClass)
C0030705 (NCI Metathesaurus ObjectClass)
C25627 (NCI Thesaurus Property)
C29848 (NCI Thesaurus Property-2)
C18772 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1956346 (UMLS CUI-1)

history of TIA

Item

Does the patient have a prior history of TIA or CVA

boolean

C29867 (NCI Thesaurus ObjectClass)
C50781 (NCI Thesaurus Property)
C3390 (NCI Thesaurus Property-2)
C18772 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0455536 (UMLS CUI-1)

HistoryofPeripheralVascularDiseasePresentInd-3

Item

Does the patient have a history of symptomatic peripheral vascular disease

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C66923 (NCI Thesaurus ObjectClass)
C1881056 (UMLS 2011AA ObjectClass)

History of arterial thrombotic event

Item

Does the patient have a history of arterial thrombotic event within the past 12 months

boolean

C16960 (NCI Thesaurus ObjectClass)
C26891 (NCI Thesaurus ObjectClass-2)
C12372 (NCI Thesaurus ObjectClass-3)
C25627 (NCI Thesaurus Property)
C29848 (NCI Thesaurus Property-2)
C18772 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0332119 (UMLS CUI-1)
C1869078 (UMLS CUI-2)

PatientWoundHistoryInd-2

Item

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

boolean

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

PatientGastrointestinalHistoryUlcerationInd-2

Item

Does the patient have active gastroduodenal ulcer(s) determined by endoscopy to be active?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)

PatientAdditionalClinicalTrialEligibilityCriteriaInd-2

Item

Does the patient meet all other eligibility criteria?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25406 (NCI Thesaurus Property)
C1524062 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)

Eligibility for trial

Item

In the opinion of the investigator, is the patient eligible?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1302261 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)

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Colon cancer (NSABP C-08 NCT00096278)

Refer to patient entry guidelines in the Members' Area of the NSABP Web site.

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