ID

43106

Description

NSABP PROTOCOL R-04: REGISTRATION FORM NCT00058474 Radiation Therapy and Either Capecitabine or Fluorouracil With or Without Oxaliplatin Before Surgery in Treating Patients With Resectable Rectal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B7825AE7-F18A-259D-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B7825AE7-F18A-259D-E034-0003BA12F5E7

Keywords

Colorectal Neoplasms

Clinical Trial

Registration

Uploaded on

September 20, 2021

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy

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NSABP PROTOCOL R-04: REGISTRATION FORM NCT00058474

model
Details

#Not required for patients =70 years if age, For patients < 70 years of age with a serum creatinine > ULN either a measured or a calculated creatinine clearance is required.

1 forms

StudyEvent: NSABP PROTOCOL R-04: REGISTRATION FORM
1. #Not required for patients =70 years if age, For patients < 70 years of age with a serum creatinine > ULN either a measured or a calculated creatinine clearance is required.

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Header

Item Group

Ccrr Module For Nsabp Protocol R-04: Registration Form

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)

PatientMedicalRecordNumber

Item

Patient Medical Record Number

text

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 bottles 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 Group

Person Completing Form, Last Name

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 Last

Item

Last

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1517741 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)

Patient Initials First

Item

First

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C0205435 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)

PatientMiddleInitialsName

Item

Middle

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)

Birth Date

Item

Patient Birth Date (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)

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 Categories (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 Categories (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)

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)

CL Item

Veterans Sponsored (Veterans Sponsored)

CL Item

Self Pay (no Insurance) (Self pay)

CL Item

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

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)

Country of current residence

Item

Other

text

C16960 (NCI Thesaurus ObjectClass)
C3258975 (UMLS CUI-1)
C25464 (NCI Thesaurus ValueDomain)
C25407 (NCI Thesaurus Property)
C42614 (NCI Thesaurus ValueDomain-2)

Country of current residence

Item

Other

text

C16960 (NCI Thesaurus ObjectClass)
C3258975 (UMLS CUI-1)
C25464 (NCI Thesaurus ValueDomain)
C25407 (NCI Thesaurus Property)
C42614 (NCI Thesaurus ValueDomain-2)

PatientAddressPostalCode

Item

Patient's Zip Code (USA)

text

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

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

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

CL Item

Restricted in physically strenous activity but ambulatory (Restricted in physically strenous activity but ambulatory)

CL Item

Ambulatory and capable of all selfcare but unable to carry out any work activities (Ambulatory and capable of all selfcare but unable to carry out any work activities)

CL Item

Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours (Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours)

CL Item

Completely disabled (Completely disabled)

Patient Height

Item

Patient Height

float

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

Patient Weight

Item

Patient Weight

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

Female Gender (FEMALE)

C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)

CL Item

Male Gender (MALE)

C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)

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)

Required Studies

Item Group

Certificiation Of Eligibility

Assessment Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

Assessment Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

Assessment Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

Assessment Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

Assessment Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

Assessment Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

Evaluation method

Item

Method of Evaluation (or)

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

CL.16

Code List

Method of Evaluation (or)

CL Item

Proctoscopy/sigmoidoscopy (Proctoscopy/sigmoidoscopy)

Evaluation method

Item

Method of Evaluation (or)

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

CL.16

Code List

Method of Evaluation (or)

CL Item

Proctoscopy/sigmoidoscopy (Proctoscopy/sigmoidoscopy)

Evaluation method

Item

Method of Evaluation (or)

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

CL.16

Code List

Method of Evaluation (or)

CL Item

Proctoscopy/sigmoidoscopy (Proctoscopy/sigmoidoscopy)

Evaluation method

Item

Method of Evaluation (or)

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

CL.16

Code List

Method of Evaluation (or)

CL Item

Proctoscopy/sigmoidoscopy (Proctoscopy/sigmoidoscopy)

Evaluation method

Item

Method of Evaluation (or)

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

CL.16

Code List

Method of Evaluation (or)

CL Item

Proctoscopy/sigmoidoscopy (Proctoscopy/sigmoidoscopy)

Evaluation method

Item

Method of Evaluation (or)

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

CL.16

Code List

Method of Evaluation (or)

CL Item

Proctoscopy/sigmoidoscopy (Proctoscopy/sigmoidoscopy)

AssessmentImageReportingType

Item

Result

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25651 (NCI Thesaurus ValueDomain-2)
C0700287 (UMLS 2011AA ValueDomain-2)
C19477 (NCI Thesaurus Property)
C1704254 (UMLS 2011AA Property)

CL.14

Code List

Result

CL Item

Negative (negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Suspicious (Suspicious)

C0750493 (NCI Metathesaurus)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

AssessmentImageReportingType

Item

Result

text

CL.14

Code List

Result

CL Item

Negative (negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Suspicious (Suspicious)

C0750493 (NCI Metathesaurus)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

AssessmentImageReportingType

Item

Result

text

CL.14

Code List

Result

CL Item

Negative (negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Suspicious (Suspicious)

C0750493 (NCI Metathesaurus)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

Staging of Primary Tumor

Item Group

Staging Of Primary Tumor

ColorectalTumorStageGroupingAssessmentType

Item

Procedure Used to Definitively Stage Primary Tumor

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38027 (NCI Thesaurus Property-2)
C1519504 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.17

Code List

Procedure Used to Definitively Stage Primary Tumor

CL Item

Ct/combined Pet/ct (CT/Combined PET/CT)

CL Item

Magnetic Resonance Imaging (MRI)

C16809 (NCI Thesaurus)
C0024485 (UMLS 2011AA)

CL Item

Ultrasound (Ultrasound)

C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)

Assessment Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

Quality of Life

Item Group

Quality Of Life

BaselineQOLCompleteFormInd-2

Item

Did the patient complete the Quality of Life baseline form?

boolean

C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25213 (NCI Thesaurus ObjectClass-2)
C1442488 (UMLS 2011AA ObjectClass-2)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25250 (NCI Thesaurus Property-2)
C0205197 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

BaselineQOLIncompleteFormReason

Item

If the baseline QOL form was not completed, indicate the reason below.

text

C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25213 (NCI Thesaurus ObjectClass-2)
C1442488 (UMLS 2011AA ObjectClass-2)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property-2)
C0205257 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)

CL.19

Code List

If the baseline QOL form was not completed, indicate the reason below.

CL Item

Other Reason (Other reason)

CL Item

Patient Does Not Speak English, French, Or Spanish (Patient does not speak English, French, or Spanish)

CL Item

Patient Refused (Patient refused)

BaselineQOLIncompleteFormSpecify

Item

Other reason, specify

text

C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25213 (NCI Thesaurus ObjectClass-2)
C1442488 (UMLS 2011AA ObjectClass-2)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property-2)
C0205257 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Hematologies

Item Group

Hematologies

SpecimenLaboratoryProcedureCollectionDate

Item

Date of Hematologies (Year Day Month)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)

Hemoglobin

Item

Hemoglobin (g/dL)

float

C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

HematologyPlateletLabUnspecifiedValue

Item

Platelets (thsnd/mm?)

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

ANC

Item

ANC (AGC/ - thsnd/mm^3)

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)

Chemistries

Item Group

Chemistries

Assessment Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

Lab,Hepatic,Bilirubin

Item

Total Bilirubin (mg/dL)

float

HepaticBilirubinLabUpperLimitNormalValue

Item

Bilirubin ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

Lab,Hepatic,AlkalinePhosphatase

Item

Alkaline Phosphatase

float

Alkaline Phosphatase ULN

Item

Alkaline Phosphatase ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)

HepaticSGOT(AST)LabUnspecifiedValue

Item

AST (SGOT)

float

C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Item

SGOT (AST) ULN

float

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)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

RenalCreatinineLabSpecifiedValue

Item

Creatinine

float

C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

Creatinine, serum ULN

Item

Creatinine ULN

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)

Creatinine Clearance

Item

Creatinine Clearance (Calculated)

float

C20200 (NCI Thesaurus Property)
C0373595 (UMLS CUI-1)
C25747 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

MalignantAnalNeoplasmPresentInd-2

Item

Are there multiple rectal tumors?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C7379 (NCI Thesaurus ObjectClass)
C0153446 (UMLS 2011AA ObjectClass)

ColorectalTumorSurroundingStructureFixedInd-2

Item

Is the tumor fixed to surrounding structures?

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C1185713 (NCI Metathesaurus Property)
C41186 (NCI Thesaurus Property)
C0678594 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.21

Code List

Is the tumor fixed to surrounding structures?

CL Item

Yes (Yes, Specify)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

ColorectalTumorSurroundingStructureFixedSpecify

Item

Yes, specify

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C1185713 (NCI Metathesaurus Property)
C41186 (NCI Thesaurus Property)
C0678594 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Tumor Extension

Item Group

Tumor Extension

ColorectalTumorClinicalTStage

Item

Clinical T Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.22

Code List

Clinical T Stage

CL Item

No Evidence Of Primary Tumor (T0)

CL Item

Tumor Invades Submucosa (T1)

CL Item

Tumor Invades Muscularis Propria (T2)

CL Item

Tumor Invades Through The Muscularis Propria Into The Subserosa, Or Into Nonperitonealized Pericolic Or Perirectal Tissues (T3)

CL Item

Tumor Directly Invades Other Organs Or Structures, And/or Perforates Visceral Peritoneum (T4)

CL Item

Carcinoma In Situ: Intraepithelial Or Invasion Of Lamina Propria (Tis)

CL Item

Primary Tumor Cannot Be Assessed (TX)

RegionalLymphNodeInvolvedInd-3

Item

Regional Lymph Nodes (Evidence of positive >= 1.0 cm)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25643 (NCI Thesaurus ObjectClass-2)
C0205147 (UMLS 2011AA ObjectClass-2)
C25547 (NCI Thesaurus Property)

ColorectalSurgicalProcedurePlannedColorectalSurgicalProcedurePerformedType

Item

Intended Operative Procedure

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)

CL.24

Code List

Intended Operative Procedure

CL Item

Sphincter Saving Surgery (SPHINCTER SAVING SURGERY)

CL Item

Non-sphincter Saving Surgery (NON-SPHINCTER SAVING SURGERY)

Biopsy specimen

Item Group

Biopsy specimen

BiopsySpecimenRNALaterCollectionInd-2

Item

Did the patient have a previous biopsy sample collected in RNAlater

boolean

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C63348 (NCI Thesaurus Property)
C1882529 (UMLS 2011AA Property)
C25453 (NCI Thesaurus Property-2)
C1516698 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

BiopsySpecimenRNALaterCollectionConsentind-2

Item

I agree to undergo an additional biopsy so that a sample of my tumor can be collected in RNAlater solution and sent to the NSABP (If no, then how did the patient answer the following question from the consent form:)

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C63348 (NCI Thesaurus Property-2)
C1882529 (UMLS 2011AA Property-2)
C25453 (NCI Thesaurus Property-3)
C1516698 (UMLS 2011AA Property-3)
C19157 (NCI Thesaurus Property-4)
C0370003 (UMLS 2011AA Property-4)
C25460 (NCI Thesaurus Property-5)
C1511481 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

BiopsySpecimenRNALaterCollectionIdentifierConsentInd-2

Item

I agree to let my doctor release the coded link to my R-04 study identification number so my biopsy sample that was collected in RNAlater may be used in the R-04 study (If yes, then how did the patient answer the following question from the consent form:)

boolean

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C63348 (NCI Thesaurus Property-2)
C1882529 (UMLS 2011AA Property-2)
C25453 (NCI Thesaurus Property-3)
C1516698 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

BiopsySpecimenRNALaterCollectionNumber

Item

Code (If yes, provide)

text

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C63348 (NCI Thesaurus Property)
C1882529 (UMLS 2011AA Property)
C25453 (NCI Thesaurus Property-2)
C1516698 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

PatientMalignantNeoplasmConsentInd-2

Item

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

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)

SouthwestOncologyGroupPatientResearchConsentInd-2

Item

I agree to allow my study doctor, or someone approved by my study doctor, to contact me regard future research involving my participation in this study (My study doctor or someone he or she chooses may contact me in the future to ask me to take part in more research)

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C1519429 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

NationalSurgicalAdjuvantBreastandBowelProjectPatientInclusionClinicalTrialEligibilityCriteriaType

Item

Eligibility Checklist (This is not a complete list of the eligibility criteria. Please see protocol.)

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15818 (NCI Thesaurus ObjectClass-2)
C1513905 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property-2)
C1512693 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.30

Code List

Eligibility Checklist (This is not a complete list of the eligibility criteria. Please see protocol.)

CL Item

Does The Patient Have A Tumor That Is Clinically Stage Ii Or Iii And A Diagnosis Of Adenocarcinoma Of The Rectum Obtained By A Biopsy Technique Which Leaves The Major Portion Of The Tumor Intact (Does the patient have a tumor that is clinically Stage II or III and a diagnosis of adenocarcinoma of the rectum obtained by a biopsy technique which leaves the major portion of the tumor intact)

CL Item

Does The Patient Have Clinically Significant Peripheral Neuropathy At The Time Of Randomization (defined In The Ctcae V3.0 As Grade 2 Or Greater Neurosensory Or Neuromotor Toxicity) (Does the patient have clinically significant peripheral neuropathy at the time of randomization (defined in the CTCAE v3.0 as grade 2 or greater neurosensory or neuromotor toxicity))

CL Item

Does The Patient Have Ischemic Heart Disease (class Iii Or Class Iv Myocardial Disease - New York Heart Association), Uncontrolled Hypertension, Symptomatic Arrhythmia Or A History Of Myocardial Infarction Within The Past 6 Months (Does the patient have ischemic heart disease (class III or class IV myocardial disease - New York Heart Association), uncontrolled hypertension, symptomatic arrhythmia or a history of myocardial infarction within the past 6 months)

CL Item

Does The Patient Have Psychiatric Or Addictive Disorders That Would Preclude Obtaining Informed Consent (Does the patient have psychiatric or addictive disorders that would preclude obtaining informed consent)

CL Item

Does The Patient Have Synchronous Colon Cancer (Does the patient have synchronous colon cancer)

CL Item

Does The Patient Meet All Other Eligibility Criteria (Does the patient meet all other eligibility criteria)

CL Item

Does The Surgeon Consider The Tumor To Be Amenable To Curative Resection (Does the surgeon consider the tumor to be amenable to curative resection)

CL Item

Has The Patient Authorized The Release Of Protected Health Information To The Nsabp (Has the patient authorized the release of Protected Health Information to the NSABP)

CL Item

Has The Patient Consented To Participate In This Study And Signed And Dated An Approved Consent Form (Has the patient consented to participate in this study and signed and dated an approved consent form)

CL Item

Has The Patient Had A Prior Invasive Rectal Malignancy (regardless Of The Disease-free Interval) (Has the patient had a prior invasive rectal malignancy (regardless of the disease-free interval))

CL 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 Cervix , Or Carcinoma In Situ Of The Colon Or Rectum That Have Been Effectively Treated (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 cervix , or carcinoma in situ of the colon or rectum that have been effectively treated)

CL Item

Is The Distal Border Of The Tumor Located Less Than 12 Cm From The Anal Verge (Is the distal border of the tumor located less than 12 cm from the anal verge)

CL Item

Has The Patient Received Any Therapy For This Cancer Prior To Randomization Or Had Prior Pelvic Radiation For Any Reason (Has the patient received any therapy for this cancer prior to randomization or had prior pelvic radiation for any reason)

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Item comments for :

NSABP PROTOCOL R-04: REGISTRATION FORM NCT00058474

#Not required for patients =70 years if age, For patients < 70 years of age with a serum creatinine > ULN either a measured or a calculated creatinine clearance is required.

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