ID

1811

Beskrivning

RTOG 1016 S1: Radiation Therapy Oncology Group Phase III Head a& Neck Cancer Surgery Form Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9A132BA5-915B-FFE2-E040-BB89AD43727A

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9A132BA5-915B-FFE2-E040-BB89AD43727A

Nyckelord

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

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19 september 2012

DOI

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Head and Neck Cancer NCT01302834 Treatment - RTOG 1016 S1: Radiation Therapy Oncology Group Phase III Head a& Neck Cancer Surgery Form - 3183854v1.0

model
Detaljer

INSTRUCTIONS: Submit for all patients within 2 weeks of study entry. Submit with copies of the operative report (S2) and surgical pathology report (S5). Dates are mm-dd-yyyy unless otherwise specified

1 Formulär

StudyEvent: RTOG 1016 S1: Radiation Therapy Oncology Group Phase III Head a& Neck Cancer Surgery Form
1. INSTRUCTIONS: Submit for all patients within 2 weeks of study entry. Submit with copies of the operative report (S2) and surgical pathology report (S5). Dates are mm-dd-yyyy unless otherwise specified

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Header Module

Item Group

Unnamed Module 1

ProtocolRTOGIdentifierNumber

Item

RTOG Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus Property)
C1514695 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

Item

Case #

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus ObjectClass)
C1514695 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49152 (NCI Thesaurus Property)
C1706256 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

InstitutionName

Item

Institution Name

text

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

InstitutionIdentifierNumber

Item

Institution No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientInitialsName

Item

Patient Initials

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)

PatientRadiationTherapyOncologyGroupIdentifierNumber

Item

RTOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus Property)
C1514695 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

DataAmendedInd-3

Item

Amended Data

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

CL.1

Code List

Amended Data

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

MODULE 2

Item Group

Module 2

ResidualDiseaseAnatomicalLocationText

Item

Location of remaining disease

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C4809 (NCI Thesaurus ObjectClass)
C0543478 (UMLS 2011AA ObjectClass)
C0923870 (NCI Metathesaurus Property)

ResidualDiseaseAnatomicalLocationText

Item

Location of remaining disease

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C4809 (NCI Thesaurus ObjectClass)
C0543478 (UMLS 2011AA ObjectClass)
C0923870 (NCI Metathesaurus Property)

ResidualDiseaseAnatomicalLocationText

Item

Location of remaining disease

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C4809 (NCI Thesaurus ObjectClass)
C0543478 (UMLS 2011AA ObjectClass)
C0923870 (NCI Metathesaurus Property)

PrimarySurgeryDate

Item

Primary Surgery Date

date

C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

SurgicalProcedureHeadandNeckMalignantNeoplasmResultStatus

Item

Primary Site (Pathologic Assessment)

text

C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C12418 (NCI Thesaurus Property)
C0460004 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.3

Code List

Primary Site (Pathologic Assessment)

CL Item

No Tumor Demonstrable On Final Pathology Specimen (No tumor demonstrable on final pathology specimen)

CL Item

Not Operated (Not operated)

CL Item

Tumor Present All Margins Clear On Final Pathology Specimen (Tumor present all margins clear on final pathology specimen)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Tumor Present, Margin Involved On Final Specimen (Tumor present margin involved on final pathology specimen)

SurgicalProcedureHeadandNeckMalignantNeoplasmResultStatus

Item

Primary Site (Pathologic Assessment)

text

CL.3

Code List

Primary Site (Pathologic Assessment)

CL Item

No Tumor Demonstrable On Final Pathology Specimen (No tumor demonstrable on final pathology specimen)

CL Item

Not Operated (Not operated)

CL Item

Tumor Present All Margins Clear On Final Pathology Specimen (Tumor present all margins clear on final pathology specimen)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Tumor Present, Margin Involved On Final Specimen (Tumor present margin involved on final pathology specimen)

SurgicalProcedureHeadandNeckLymphadenectomyPerformedType

Item

Nodal surgery

text

C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C12418 (NCI Thesaurus Property)
C0460004 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15275 (NCI Thesaurus Property)
C0024203 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.4

Code List

Nodal surgery

CL Item

Bilateral Node Dissection (Bilateral node dissection)

CL Item

None (None)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Unilateral Lymph Node Dissection Left (Unilateral node dissection (left))

CL Item

Unilateral Lymph Node Dissection Right (Unilateral node dissection (right))

HeadandNeckRightLymphNodeNeoplasmInvolvementStatus

Item

Neck nodal site right

text

C25228 (NCI Thesaurus ObjectClass)
C0205090 (UMLS 2011AA ObjectClass)
C12418 (NCI Thesaurus ObjectClass)
C0460004 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.5

Code List

Neck nodal site right

CL Item

Complete Resection Of All Gross Tumor (Complete resection of all gross disease)

CL Item

Incomplete/partial Resection Of Gross Tumor (Incomplete/partial resection of gross tumor)

CL Item

Not Operated (Not operated)

HeadandNeckLeftLymphNodeNeoplasmInvolvementStatus

Item

Neck nodal site left

text

C25229 (NCI Thesaurus ObjectClass)
C0205091 (UMLS 2011AA ObjectClass)
C12418 (NCI Thesaurus ObjectClass)
C0460004 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.6

Code List

Neck nodal site left

CL Item

Complete Resection Of All Gross Tumor (Complete resection of all gross disease)

CL Item

Incomplete/partial Resection Of Gross Tumor (Incomplete/partial resection of gross tumor)

CL Item

Not Operated (Not operated)

SurgicalProcedureHeadandNeckLymphadenectomyPerformedDate

Item

Nodal Surgery Date (Left)

date

C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C12418 (NCI Thesaurus Property)
C0460004 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15275 (NCI Thesaurus Property)
C0024203 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

SurgicalProcedureHeadandNeckLymphadenectomyPerformedDate

Item

Nodal Surgery Date (Left)

date

C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C12418 (NCI Thesaurus Property)
C0460004 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15275 (NCI Thesaurus Property)
C0024203 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Neck Nodal Sites (Pathologic Assessment)

Item Group

Neck Nodal Sites (pathologic Assessment)

HeadandNeckLymphNodeAssessmentSite

Item

Location

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12418 (NCI Thesaurus ObjectClass)
C0460004 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)

CL.7

Code List

Location

CL Item

Left - Level I (submandibular) (Left - Level I (Submandibular))

CL Item

Left - Level Ii (upper 1/3 Internal Jugular) (Left - Level II (Upper 1/3 Internal Jugular))

CL Item

Left - Level Iii (mid 1/3 Internal Jugular) (Left - Level III (Mid 1/3 Internal Jugular))

CL Item

Left - Level Iv (lower 1/3 Internal Jugular) (Left - Level IV (Lower 1/3 Internal Jugular))

CL Item

Left - Level V (posterior Triangle) (Left - Level V (Posterior Triangle))

CL Item

Left - Other (Left - Other specify)

CL Item

Right - Level I (submandibular) (Right - Level I (Submandibular))

CL Item

Right - Level Ii (upper 1/3 Internal Jugular) (Right - Level II (Upper 1/3 Internal Jugular))

CL Item

Right - Level Iii (mid 1/3 Internal Jugular) (Right - Level III (Mid 1/3 Internal Jugular))

CL Item

Right - Level Iv (lower 1/3 Internal Jugular) (Right - Level IV (Lower 1/3 Internal Jugular))

CL Item

Right - Level V (posterior Triangle) (Right - Level V (Posterior Triangle))

CL Item

Right - Other (Right - Other specify)

HeadandNeckLymphNodeRightRemovedSpecify

Item

Other specify (location)

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25228 (NCI Thesaurus Property)
C0205090 (UMLS 2011AA Property)
C12418 (NCI Thesaurus ObjectClass)
C0460004 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25650 (NCI Thesaurus Property)
C0849355 (UMLS 2011AA Property)

HeadandNeckLymphNodeLeftRemovedSpecify

Item

Other specify (location)

text

C12418 (NCI Thesaurus ObjectClass)
C0460004 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25229 (NCI Thesaurus Property)
C0205091 (UMLS 2011AA Property)
C25650 (NCI Thesaurus Property)
C0849355 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

LymphNodePositiveCount

Item

Number of Positive Lymph Nodes

double

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

LymphNodeExaminedCount

Item

Number of Lymph Nodes Examined

double

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

DiseaseExtracapsularExtensionInd-3

Item

Extracapsular Extension?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25270 (NCI Thesaurus Property)
C0231448 (UMLS 2011AA Property)

CL.8

Code List

Extracapsular Extension?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

RightLymphNodePositiveTotalCount

Item

Total Nodes Positive Right

double

C25228 (NCI Thesaurus ObjectClass)
C0205090 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

RightLymphNodeExaminedTotalCount

Item

Total Nodes Examined Right

double

C25228 (NCI Thesaurus ObjectClass)
C0205090 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

LeftLymphNodePositiveTotalCount

Item

Total Nodes Positive Left

double

C25229 (NCI Thesaurus ObjectClass)
C0205091 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

LeftLymphNodeExaminedTotalCount

Item

Total Nodes Examined Left

double

C25229 (NCI Thesaurus ObjectClass)
C0205091 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

HeadandNeckConnectiveTissueNeoplasmWithoutLymphNodePresentIndicator

Item

Was tumor present in the soft tissue of the neck without an identifiable lymph node present?

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12418 (NCI Thesaurus ObjectClass)
C0460004 (UMLS 2011AA ObjectClass)
C12374 (NCI Thesaurus ObjectClass)
C0009780 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12745 (NCI Thesaurus Property)
C0024204 (UMLS 2011AA Property)
C25718 (NCI Thesaurus Property)
C0332288 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.9

Code List

Was tumor present in the soft tissue of the neck without an identifiable lymph node present?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Operated (Not operated)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

HeadandNeckConnectiveTissueNeoplasmWithoutLymphNodePresentSpecify

Item

Yes specify level

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12418 (NCI Thesaurus ObjectClass)
C0460004 (UMLS 2011AA ObjectClass)
C12374 (NCI Thesaurus ObjectClass)
C0009780 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12745 (NCI Thesaurus Property)
C0024204 (UMLS 2011AA Property)
C25718 (NCI Thesaurus Property)
C0332288 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Footer Module

Item Group

Footer Module

ResearchCommentsText

Item

Comments

text

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

ResponsiblePersonSignatureText

Item

Signature of Person Completing This Form

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)

FormOriginalCompleteDate

Item

Form Completion Date, Original

date

C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

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Head and Neck Cancer NCT01302834 Treatment - RTOG 1016 S1: Radiation Therapy Oncology Group Phase III Head a& Neck Cancer Surgery Form - 3183854v1.0

INSTRUCTIONS: Submit for all patients within 2 weeks of study entry. Submit with copies of the operative report (S2) and surgical pathology report (S5). Dates are mm-dd-yyyy unless otherwise specified

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