ID

848

Description

SOUTHWEST ONCOLOGY GROUP Prestudy Form (S0347) Vinorelbine With or Without Trastuzumab in Treating Women With Progressive Metastatic Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=01ECF016-02E2-1026-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=01ECF016-02E2-1026-E044-0003BA3F9857

Keywords

Breast Neoplasms

Pre-Study Form

8/26/12 8/26/12 -
1/9/15 1/9/15 - Martin Dugas

Uploaded on

August 26, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00103233 Pre-Study - SOUTHWEST ONCOLOGY GROUP Prestudy Form (S0347) - 2412719v1.0

model
Details

No Instruction available.

1 forms

StudyEvent: SOUTHWEST ONCOLOGY GROUP Prestudy Form (S0347)
1. No Instruction available.

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Unnamed1

Item Group

Unnamed1

PatientSouthwestOncologyGroupIdentifierNumber

Item

SWOG Patient ID

double

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)

ProtocolSWOGIdentifierNumber

Item

SWOG Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)

RegistrationStepNumber

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)

PatientInitialsName

Item

Patient Initials (L, F M)

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)

CombinedInstitutionName

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)

RegisteredInvestigatorName

Item

Physician (Participating Group:)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus ObjectClass)

GroupName

Item

Group Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ProtocolParticipatingIdentifierNumber

Item

Participating Group Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientParticipatingIdentifierNumber

Item

Participating Group Patient ID (Instructions: All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across the top of the form.)

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PATIENT CHARACTERISTICS

Item Group

Patient Characteristics

PatientHeightMeasurement

Item

Height

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)

PatientWeightMeasurement

Item

Weight

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (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.1

Code List

Performance Status

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)

MENOPAUSAL STATUS

Item Group

Menopausal Status

PatientMenopauseCategory

Item

Menopausal Status

text

C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C3231 (NCI Thesaurus ValueDomain)
C0025320 (UMLS 2011AA ValueDomain)

CL.2

Code List

Menopausal Status

CL Item

Pre (<6 Mo Since Lmp And No Prior Bilateral Ovariectomy And Not On Estrogen Replacement) (Pre (< 6 mo since LMP and no prior bilateral ovariectomy and not on estrogen replacement))

CL Item

Post (prior Bilateral Ovariectomy Or >12 Mo Since Lmp With No Prior Hysterectomy And Not Currently Receiving Therapy With Lh-rh Analogs [e.g., Zoladex]) (Post (prior bilateral ovariectomy OR > 12 mo since LMP with no prior hysterectomy and not currently receiving therapy with LH-RH analogs [e.g. Zoladex]))

CL Item

Above Categories Not Applicable And Age <50 (Above not applicable AND age < 50)

CL Item

Above Categories Not Applicable And Age >= 50 (Above not applicable AND age >=50)

DISEASE DESCRIPTION

Item Group

Disease Description

PatientSouthwestOncologyGroupIdentifierNumber

Item

SWOG Patient ID

double

EstrogenReceptorSummaryResult

Item

ER Result

text

C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

CL.3

Code List

ER Result

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Not Done (Never Done or Unknown)

CL281691 (NCI Metathesaurus)

ProtocolSWOGIdentifierNumber

Item

SWOG Study No.

text

EREvaluationType

Item

ER Time

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)

CL.4

Code List

ER Time

CL Item

At Initial Primary Diagnosis (At initial primary diagnosis)

CL Item

At Disease Recurrence (At disease recurrence)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

RegistrationStepNumber

Item

Registration Step

text

EREvaluationSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)

PatientInitialsName

Item

Patient Initials (L, F M)

text

PgRResultType

Item

PgR Result

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)

CL.5

Code List

PgR Result

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Never Done Or Unknown (Never Done or Unknown)

PgREvaluationType

Item

PgR Time

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)

CL.6

Code List

PgR Time

CL Item

At Initial Primary Diagnosis (At initial primary diagnosis)

CL Item

At Disease Recurrence (At disease recurrence)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

PgREvaluationSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)

HER2/neuStatusType

Item

HER-2/neu Status

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ObjectClass)
C0242957 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.7

Code List

HER-2/neu Status

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Equivocal (Equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

CL Item

Never Done Or Unknown (Never Done or Unknown)

HER2/neuEvaluationType

Item

HER-2/neu Time

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C17756 (NCI Thesaurus ObjectClass)
C0242957 (UMLS 2011AA ObjectClass)

CL.8

Code List

HER-2/neu Time

CL Item

At Initial Primary Diagnosis (At initial primary diagnosis)

CL Item

At Disease Recurrence (At disease recurrence)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

HER2/neuEvaluationSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C17756 (NCI Thesaurus ObjectClass)
C0242957 (UMLS 2011AA ObjectClass)

FirstBiopsyPositiveDate

Item

Date of initial diagnosis of primary tumor

date

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ObjectClass)
C1279901 (UMLS 2011AA ObjectClass)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

DiseaseRecurrenceDate

Item

Date progressive, recurrent or metastatic disease first diagnosed (radiologic or pathologic)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C3352 (NCI Thesaurus Property)
C0034897 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

SWOGDiseaseInvolvedSite

Item

Involved sites at time of entry (select all involved sites)

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

CL.9

Code List

Involved sites at time of entry (select all involved sites)

CL Item

Local-regional (Local-regional)

C25388 (NCI Thesaurus)
C1947913 (UMLS 2011AA)

CL Item

Ipsilateral Supraclavicular Nodes (ipsilateral supraclavicular nodes)

CL Item

Opposite Breast (Opposite breast)

CL Item

Distant Lymph Nodes (Distant nodes)

CL Item

Distant Skin/subcutaneous Tissue (Distant skin/subcutaneous tissue)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Bone Marrow (Bone marrow)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Pleura (Pleura)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Brain (Brain)

CL Item

Other Cns (Other CNS)

CL Item

Other (Other sites)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

SWOGDiseaseInvolvedLocationSpecify

Item

Other sites, specify

text

C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25547 (NCI Thesaurus Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ValueDomain)
C0012634 (UMLS 2011AA ValueDomain)

PRIOR TREATMENT RELATED TO THIS CANCER

Item Group

Prior Treatment Related To This Cancer

SWOGPriorTherapyAdministrationSpecify

Item

Other therapy, specify

text

C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

SWOGRTAdministeredType

Item

Radiation (select one)

text

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.10

Code List

Radiation (select one)

CL Item

Extensive Radiation (Extensive RT)

C16230 (NCI Thesaurus)
C1517030 (UMLS 2011AA)

CL Item

Limited Radiation (Limited RT)

CL Item

Not Otherwise Specified (Not otherwise specified)

CL006269 (NCI Metathesaurus)

SWOGPriorTherapyAdministeredType

Item

Has the patient had any of the following prior treatments? (select ALL that apply)

text

C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.11

Code List

Has the patient had any of the following prior treatments? (select ALL that apply)

CL Item

Surgery (Surgery)

C17173 (NCI Thesaurus)
C0038894 (UMLS 2011AA)

CL Item

Gene Transfer (Gene transfer)

C20185 (NCI Thesaurus)
C1517499 (UMLS 2011AA)

CL Item

Anti-retroviral Therapy (Anti-retroviral therapy)

CL Item

Antisense (Antisense)

CL Item

Oncolytic Virotherapy (Oncolytic virotherapy)

CL Item

Vaccine (Vaccine)

C923 (NCI Thesaurus)
C0042210 (UMLS 2011AA)

CL Item

High-dose Chemotherapy With Marrow Or Stem Cell Support, Adjuvant (High-dose chemotherapy with marrow or stem cell support, adjuvant)

CL Item

High-dose Chemotherapy With Marrow Or Stem Cell Support, Advanced (High-dose chemotherapy with marrow or stem cell support, advanced)

CL Item

Immunotherapy, Adjuvant (Immunotherapy, adjuvant)

CL Item

Immunotherapy, Advanced (Immunotherapy, advanced)

CL Item

Herceptin, Adjuvant (Herceptin, adjuvant)

CL Item

Herceptin, Advanced (Herceptin, advanced)

CL Item

Other Therapy, Adjuvant (Other therapy, adjuvant)

CL Item

Other Therapy, Advanced (Other therapy, advanced)

CL Item

Chemotherapy Single Agent Systemic, Adjuvant (Chemotherapy single agent systemic, adjuvant)

CL Item

Chemotherapy Single Agent Systemic, Advanced (Chemotherapy single agent systemic, advanced)

CL Item

Chemotherapy Multi-agent Systemic, Adjuvant (Chemotherapy multi-agent systemic, adjuvant)

CL Item

Chemotherapy Multi-agent Systemic, Advanced (Chemotherapy multi-agent systemic, advanced)

CL Item

Chemotherapy Non-cytoxic, Adjuvant (Chemotherapy non-cytoxic, adjuvant)

CL Item

Chemotherapy Non-cytotoxic, Advanced (Chemotherapy non-cytotoxic, advanced)

CL Item

Chemotherapy Other, Adjuvant (Chemotherapy other, adjuvant)

CL Item

Chemotherapy Other, Advanced (Chemotherapy other, advanced)

CL Item

Hormonal Therapy, Adjuvant (Hormonal therapy, adjuvant)

CL Item

Hormonal Therapy, Advanced (Hormonal therapy, advanced)

PriorChemotherapyRegimenNumber

Item

Number of prior chemotherapy regimens

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

PriorChemotherapyMetastaticRegimenCount

Item

Number of prior chemotherapy regimens for metastatic disease

double

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

Comments

Item Group

Comments

ResearchCommentsText

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

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Model comments :

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Item comments for :

Breast Cancer NCT00103233 Pre-Study - SOUTHWEST ONCOLOGY GROUP Prestudy Form (S0347) - 2412719v1.0

No Instruction available.

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