ID

6273

Description

RTOG 0920 OPEN Registration Worksheet - Step 2 Radiation Therapy With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A0190014-3FCB-4E42-E040-BB89AD43786E

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A0190014-3FCB-4E42-E040-BB89AD43786E

Keywords

  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 9/17/21 9/17/21 -
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December 18, 2014

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Creative Commons BY-NC 3.0 Legacy

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Head and Neck Cancer NCT00956007 Registration - RTOG 0920 OPEN Registration Worksheet - Step 2 - 3219537v1.0

No Instruction available.

  1. StudyEvent: RTOG 0920 OPEN Registration Worksheet - Step 2
    1. No Instruction available.
Module 1
Description

Module 1

Institutional person randomizing case
Description

RandomizationPersonName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25196
UMLS 2011AA ObjectClass
C0034656
Is the patient able to continue protocol treatment?
Description

ProtocolTherapeuticProcedureContinueAdministrationInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus ObjectClass
C49236
UMLS 2011AA ObjectClass
C0087111
NCI Thesaurus Property
C53279
UMLS 2011AA Property
C0549178
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
If no, specify the reason the patient cannot continue to Step 2
Description

ProtocolTherapeuticProcedureDiscontinueAdministrationReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus ObjectClass
C49236
UMLS 2011AA ObjectClass
C0087111
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Specify the reason the patient cannot continue to Step 2
Description

ProtocolTherapeuticProcedureDiscontinueAdministrationSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus ObjectClass
C49236
UMLS 2011AA ObjectClass
C0087111
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Patient Initials (First Middle Last)
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Verifying physician
Description

PhysicianPersonVerificationIdentifierName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C45513
UMLS 2011AA Property
C1711411
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Patient ID
Description

PatientCoordinatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25462
UMLS 2011AA Property
C0700114
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Module 1
Description

Module 1

Calendar base date (for Step 2)
Description

TherapeuticProcedureCalendarGenerationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C49236
UMLS 2011AA ObjectClass
C0087111
NCI Thesaurus Property
C19459
UMLS 2011AA Property
C1516147
NCI Thesaurus Property
C48151
UMLS 2011AA Property
C0079411
Randomization Date (for Step 2)
Description

PatientRandomizationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25196
UMLS 2011AA Property
C0034656
Patient has consented to take part in the Quality of Life Study
Description

PatientQualityofLifeConsentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C17047
UMLS 2011AA Property
C0518214
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
If no, provide reason
Description

PersonQualityofLifeClinicalStudyRefuseConsentReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C17047
UMLS 2011AA Property
C0518214
NCI Thesaurus Property
C49161
UMLS 2011AA Property
C1705116
NCI Thesaurus Property
C15206
UMLS 2011AA Property
C0008972
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
If response is "2) Patient refused for other reason", specify the reason
Description

PersonQualityofLifeClinicalStudyRefuseConsentOtherSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C17047
UMLS 2011AA Property
C0518214
NCI Thesaurus Property
C49161
UMLS 2011AA Property
C1705116
NCI Thesaurus Property
C15206
UMLS 2011AA Property
C0008972
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain
C17649
UMLS 2011AA ValueDomain
C0205394
If response is "5) Other reason", specify the reason the patient will not participate in the quality of life component of the study
Description

PersonQualityofLifeClinicalStudyRefuseConsentSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C17047
UMLS 2011AA Property
C0518214
NCI Thesaurus Property
C49161
UMLS 2011AA Property
C1705116
NCI Thesaurus Property
C15206
UMLS 2011AA Property
C0008972
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
If the patient agreed to participate in the quality of life component, did the patient agree to participate in Vision Tree?
Description

PatientQualityofLifeRadiationTherapyOncologyGroupVendorConsentPatientConsentInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17047
UMLS 2011AA Property
C0518214
NCI Thesaurus Property
C19778
UMLS 2011AA Property
C1514695
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property
C68608
UMLS 2011AA Property
C0042462
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Disease Type
Description

PrimarySiteofDiseaseDisordersAnatomicSite

Data type

text

Alias
NCI Thesaurus ObjectClass
C13717
UMLS 2011AA ObjectClass
C1515974
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
EGFR Expression
Description

LaboratoryProcedureEpidermalGrowthFactorReceptorGeneExpressionOutcomeStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C17068
UMLS 2011AA Property
C0034802
NCI Thesaurus Property
C16608
UMLS 2011AA Property
C0017262
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Use of IGRT?
Description

ImageGuidedRadiationTherapyAdministeredInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ObjectClass
C62727
UMLS 2011AA ObjectClass
C1831760

Similar models

No Instruction available.

  1. StudyEvent: RTOG 0920 OPEN Registration Worksheet - Step 2
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Module 1
RandomizationPersonName
Item
Institutional person randomizing case
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25196 (NCI Thesaurus ObjectClass)
C0034656 (UMLS 2011AA ObjectClass)
Item
Is the patient able to continue protocol treatment?
text
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C53279 (NCI Thesaurus Property)
C0549178 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Is the patient able to continue protocol treatment?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If no, specify the reason the patient cannot continue to Step 2
text
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
If no, specify the reason the patient cannot continue to Step 2
CL Item
Progression Of Disease (Progression of disease)
CL Item
Patient Refusal (Patient refusal)
CL Item
Physician Preference (Physician preference)
CL Item
Failure To Submit Tissue Assay (Failure to submit tissue assay)
CL Item
Other (Other)
ProtocolTherapeuticProcedureDiscontinueAdministrationSpecify
Item
Specify the reason the patient cannot continue to Step 2
text
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
PatientInitialsName
Item
Patient Initials (First Middle Last)
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)
PhysicianPersonVerificationIdentifierName
Item
Verifying physician
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C45513 (NCI Thesaurus Property)
C1711411 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
PatientCoordinatingIdentifierNumber
Item
Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item Group
Module 1
TherapeuticProcedureCalendarGenerationDate
Item
Calendar base date (for Step 2)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C19459 (NCI Thesaurus Property)
C1516147 (UMLS 2011AA Property)
C48151 (NCI Thesaurus Property)
C0079411 (UMLS 2011AA Property)
PatientRandomizationDate
Item
Randomization Date (for Step 2)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
Item
Patient has consented to take part in the Quality of Life Study
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus Property)
C0518214 (UMLS 2011AA Property)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
Code List
Patient has consented to take part in the Quality of Life Study
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If no, provide reason
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C17047 (NCI Thesaurus Property)
C0518214 (UMLS 2011AA Property)
C49161 (NCI Thesaurus Property)
C1705116 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
If no, provide reason
CL Item
Patient Refused Due To Illness (Patient refused due to illness)
CL Item
Patient Refused For Other Reason (Patient refused for other reason)
CL Item
Not Approved By Institutional Irb (Not approved by institutional IRB)
CL Item
Tool Not Available In Patient's Language (Tool not available in patient's language)
CL Item
Other, Specify (Other, specify)
PersonQualityofLifeClinicalStudyRefuseConsentOtherSpecify
Item
If response is "2) Patient refused for other reason", specify the reason
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C17047 (NCI Thesaurus Property)
C0518214 (UMLS 2011AA Property)
C49161 (NCI Thesaurus Property)
C1705116 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ValueDomain)
C0205394 (UMLS 2011AA ValueDomain)
PersonQualityofLifeClinicalStudyRefuseConsentSpecify
Item
If response is "5) Other reason", specify the reason the patient will not participate in the quality of life component of the study
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C17047 (NCI Thesaurus Property)
C0518214 (UMLS 2011AA Property)
C49161 (NCI Thesaurus Property)
C1705116 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
If the patient agreed to participate in the quality of life component, did the patient agree to participate in Vision Tree?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17047 (NCI Thesaurus Property)
C0518214 (UMLS 2011AA Property)
C19778 (NCI Thesaurus Property)
C1514695 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C68608 (NCI Thesaurus Property)
C0042462 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
If the patient agreed to participate in the quality of life component, did the patient agree to participate in Vision Tree?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Disease Type
text
C13717 (NCI Thesaurus ObjectClass)
C1515974 (UMLS 2011AA ObjectClass)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
Code List
Disease Type
CL Item
Larynx (Larynx)
C12420 (NCI Thesaurus)
C0023078 (UMLS 2011AA)
CL Item
Oral Cavity (Oral Cavity)
C12421 (NCI Thesaurus)
C0226896 (UMLS 2011AA)
CL Item
Oropharynx P16 Not Evaluable (Oropharynx p16 not evaluable)
CL Item
Oropharynx P16+ (Oropharynx p16+)
CL Item
Oropharynx P16- (Oropharynx p16-)
Item
EGFR Expression
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17068 (NCI Thesaurus Property)
C0034802 (UMLS 2011AA Property)
C16608 (NCI Thesaurus Property)
C0017262 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
EGFR Expression
CL Item
High (High)
CL Item
Low (Low)
C54722 (NCI Thesaurus)
C0205251 (UMLS 2011AA)
CL Item
Not Evaluable (Not Evaluable)
C62222 (NCI Thesaurus)
C1883425 (UMLS 2011AA)
Item
Use of IGRT?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C62727 (NCI Thesaurus ObjectClass)
C1831760 (UMLS 2011AA ObjectClass)
Code List
Use of IGRT?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

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