ID

3317

Beschreibung

S0205 Advanced Pancreas Carcinoma Prestudy Form S0205 Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F2EB1888-EFD9-210C-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F2EB1888-EFD9-210C-E034-0003BA3F9857

Stichworte

19.09.12 19.09.12 -
09.01.15 09.01.15 - Martin Dugas

Hochgeladen am

19. September 2012

DOI

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Pancreatic Cancer NCT00075686 Pre-Study - S0205 Advanced Pancreas Carcinoma Prestudy Form - 2307178v3.0

Modell
Details

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.

1 Formulare

StudyEvent: S0205 Advanced Pancreas Carcinoma Prestudy Form
1. 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.

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

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

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)

DESCRIPTION OF DISEASE

Item Group

Description Of Disease

CancerInitialDiagnosisDate

Item

Date of initial pathologic diagnosis (of pancreatic cancer)

date

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

Diseasestatus

Item

Disease Status

text

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C0449438 (NCI Metathesaurus Property)

CL.1

Code List

Disease Status

CL Item

Locally Advanced Unresectable (Locally advanced unresectable)

CL Item

Metastatic (Metastatic)

C14174 (NCI Thesaurus)
C0036525 (UMLS 2011AA)

PatientHeightMeasurement

Item

Height (cm)

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)

PatientBodySurfaceAreaMeasurement

Item

BSA

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Item

Performance Status

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)

CL.2

Code List

Performance Status

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)

CL Item

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)

PrimarySite

Item

Primary Site

text

CL.3

Code List

Primary Site

CL Item

Head Of Pancreas (Head of pancreas)

C0227579 (NCI Metathesaurus)

CL Item

Body Of Pancreas (Body of pancreas)

C0227582 (NCI Metathesaurus)

CL Item

Tail Of Pancreas (Tail of pancreas)

C0227590 (NCI Metathesaurus)

CL Item

Uncinate Process (Uncinate process)

CL Item

Diffuse (Diffuse)

C14175 (NCI Thesaurus)
C0205219 (UMLS 2011AA)

CL Item

Pancreas, Not Otherwise Specified (Pancreas, NOS)

CL Item

Other, Specify (Other)

PrimaryDiseaseSiteSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

DiseaseInvolvementSite

Item

Sites of involvement (select all that apply for current disease)

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)

CL.4

Code List

Sites of involvement (select all that apply for current disease)

CL Item

Primary Tumor/pancreas (Primary tumor/pancreas)

CL Item

Regional Lymph Nodes (Regional lymph nodes)

CL Item

Distant Lymph Nodes (Distant lymph nodes)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Peritoneum (Peritoneum)

C12770 (NCI Thesaurus)
C0031153 (UMLS 2011AA)

CL Item

Adjacent Viscera/vessels (Adjacent viscera/vessels)

CL Item

Other Specify (Other)

DiseaseInvolvedSiteSpecify

Item

Other, specify

text

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

UpperGITumorHistologicClassificationCategory

Item

Histologic Type

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C17639 (NCI Thesaurus ObjectClass)
C0203057 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)

CL.5

Code List

Histologic Type

CL Item

Ductal Adenocarcinoma (Ductal adenocarcinoma)

CL Item

Mixed Ductal-endocrine Carcinoma (Mixed Ductal-Endocrine Carcinoma)

C6879 (NCI Thesaurus)
C1301048 (UMLS 2011AA)

CL Item

Neuroendocrine Carcinoma (Neuroendocrine carcinoma)

C3773 (NCI Thesaurus)
C0206695 (UMLS 2011AA)

CL Item

Other Specify (Other)

CL Item

Undifferentiated (anaplastic) Carcinoma (Undifferentiated (anaplastic) carcinoma)

DominantTumorHistologicCategorySpecify

Item

Other, specify

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25487 (NCI Thesaurus ObjectClass)
C1527180 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

UpperGITumorHistologicGrade

Item

Histologic grade

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C17639 (NCI Thesaurus ObjectClass)
C0203057 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

CL.6

Code List

Histologic grade

CL Item

Well Differentiated (Well differentiated)

C14171 (NCI Thesaurus)
C0205615 (UMLS 2011AA)

CL Item

Moderately Differentiated (Moderately differentiated)

C14162 (NCI Thesaurus)
C0205616 (UMLS 2011AA)

CL Item

Poorly Differentiated (Poorly differentiated)

C14167 (NCI Thesaurus)
C0205617 (UMLS 2011AA)

CL Item

Undifferentiated (Undifferentiated)

C14176 (NCI Thesaurus)
C0205618 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

UpperGITumorPathologicTStage

Item

Pathologic T stage (Note: Provide clinical T stage if pathologic stage is unavailable.)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C17639 (NCI Thesaurus ObjectClass)
C0203057 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property)
C0475455 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.7

Code List

Pathologic T stage (Note: Provide clinical T stage if pathologic stage is unavailable.)

CL Item

T0, According To Ajcc Criteria (T0)

CL Item

Tis, According To Ajcc Criteria (Tis)

CL Item

T1, According To Ajcc Criteria (T1)

CL Item

T2, According To Ajcc Criteria (T2)

CL Item

T3, According To Ajcc Criteria (T3)

CL Item

T4, According To Ajcc Criteria (T4)

CL Item

Tx, According To Ajcc Criteria (Tx)

UpperGITumorPathologicNStage

Item

Pathologic N stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C17639 (NCI Thesaurus ObjectClass)
C0203057 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property)
C0456532 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.8

Code List

Pathologic N stage

CL Item

No Lymph Node Involvement According To Ajcc Guidelines (use For Esophageal, Gastric, And Pancreatic) (N0)

CL Item

N1, According To Ajcc Criteria (N1)

CL Item

Lymph Node Involvement Cannot Be Assessed According To Ajcc Guidelines (use For Esophageal, Gastric, And Pancreatic) (NX)

UpperGITumorPathologicMStage

Item

Pathologic M stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C17639 (NCI Thesaurus ObjectClass)
C0203057 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property)
C0456533 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.9

Code List

Pathologic M stage

CL Item

No Distant Metastases According To Ajcc Guidelines (M0)

CL Item

Distant Metastases Present According To Ajcc Guidelines (M1)

CL Item

Distant Metastases Presence Or Absence Cannot Be Assessed According To Ajcc Guidelines (Mx)

Prior Treatment Related to This Cancer

Item Group

Prior Treatment Related To This Cancer

PriorSystemicTherapyAdministeredInd-2

Item

Prior Systemic Therapy

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.10

Code List

Prior Systemic Therapy

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

AgentName

Item

Agent (If yes,)

text

C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

PriorSystemicTherapyAdministeredBeginDate

Item

Prior systemic therapy start date

date

C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

PriorSystemicTherapyAdministeredEndDate

Item

Prior systemic therapy stop date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

PriorRTAdministeredInd-3

Item

Prior Radiation Therapy

text

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

CL.11

Code List

Prior Radiation Therapy

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PriorTherapyBeginDate

Item

Start Date

date

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

PriorTherapyEndDate

Item

Stop Date

date

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property)
C2746065 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

PriorPancreatectomyAdministeredInd-3

Item

Prior Pancreatomy

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C15294 (NCI Thesaurus ObjectClass)
C0030279 (UMLS 2011AA ObjectClass)

CL.12

Code List

Prior Pancreatomy

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PriorPancreatectomyAdministeredDate

Item

Prior panceatectomy date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C15294 (NCI Thesaurus ObjectClass)
C0030279 (UMLS 2011AA ObjectClass)

PriorImmunotherapyAdministeredInd-3

Item

Prior Immunotherapy

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.13

Code List

Prior Immunotherapy

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

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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Pancreatic Cancer NCT00075686 Pre-Study - S0205 Advanced Pancreas Carcinoma Prestudy Form - 2307178v3.0

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.

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