ID

10565

Beschreibung

Radiation Therapy Oncology Group Initial Follow-up Form Phase III Lung Prophylactic Cranial RT Radiation Therapy in Preventing CNS Metastases in Patients With Non-Small Cell Lung Cancer NCT00048997 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9EC372A6-7094-05D5-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9EC372A6-7094-05D5-E034-080020C9C0E0

Stichworte

Versionen (4)
  1. 19.09.12 19.09.12 -
  2. 28.05.15 28.05.15 -
  3. 03.06.15 03.06.15 -
  4. 20.09.21 20.09.21 -
Hochgeladen am

3. Juni 2015

DOI

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Radiation Therapy Oncology Group Initial Follow-up Form Phase III Lung Prophylactic Cranial RT NCT00048997

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: Radiation Therapy Oncology Group Initial Follow-up Form Phase III Lung Prophylactic Cranial RT
    1. No Instruction available.
Header Module
Beschreibung

Header Module

Case #
Beschreibung

Case#

Datentyp

text

Institution
Beschreibung

InstitutionName

Datentyp

text

Institution #
Beschreibung

NCIInstitutionNumber

Datentyp

text

Patient Name
Beschreibung

PatientName

Datentyp

text

Patient ID #
Beschreibung

PatientID#

Datentyp

text

Medical history
Beschreibung

Medical history

DATE OF LAST CLINICAL ASSESSMENT
Beschreibung

CancerFollow-upStatusDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
PATIENT'S VITAL STATUS
Beschreibung

Patient'sVitalStatus

Datentyp

text

LAST CONTACT DATE / DEATH DATE
Beschreibung

DeathDate/LastContactDate

Datentyp

date

CAUSE OF DEATH
Beschreibung

DeathReason

Datentyp

text

Cause of death, other specify
Beschreibung

DeathReason,Specify

Datentyp

text

PERFORMANCE STATUS (ZUBROD)
Beschreibung

PerformanceStatus

Datentyp

text

HAS THE PATIENT DEVELOPED A FIRST PROGRESSION NOT PREVIOUSLY REPORTED? (Complete Q6 A and B)
Beschreibung

ProgressionInd

Datentyp

boolean

Sites of progression, lung
Beschreibung

Sitesofprogression,lung

Datentyp

text

Sites of progression, Lymph nodes (distant)
Beschreibung

Sitesofprogression,Lymphnodes(distant)

Datentyp

text

Sites of progression, pleural
Beschreibung

Sitesofprogression,pleural

Datentyp

text

Sites of progression, adrenals
Beschreibung

Sitesofprogression,adrenals

Datentyp

text

Sites of progression, liver
Beschreibung

Sitesofprogression,liver

Datentyp

text

Sites of progression, bone
Beschreibung

Sitesofprogression,bone

Datentyp

text

Sites of progression, CNS (Brain)
Beschreibung

Sitesofprogression,CNS(Brain)

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C12438
UMLS 2011AA ObjectClass
C0927232
CNS (Brain) Date
Beschreibung

ProgressionDate

Datentyp

date

Sites of progression, Other Specify
Beschreibung

Sitesofprogression,OtherSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain-2
C17649
UMLS 2011AA ValueDomain-2
C0205394
Site of progression, other specify
Beschreibung

ProgressionSite,Other

Datentyp

text

PROGRESSION ASSESSMENT
Beschreibung

ProgressionAssessmentMethod

Datentyp

float

HAS A NEW PRIMARY OR MDS BEEN DIAGNOSED THAT HAS NOT BEEN PREVIOUSLY REPORTED?
Beschreibung

NewPrimaryCancerInd

Datentyp

text

NEW PRIMARY SITE
Beschreibung

NewPrimarySite

Datentyp

text

NEW PRIMARY HISTOLOGIC TYPE
Beschreibung

NewPrimary,HistologicType

Datentyp

text

DATE OF DIAGNOSIS
Beschreibung

NewPrimaryCancerDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
IS THE PATIENT RECEIVING ANY NON-PROTOCOL CANCER THERAPY NOT PREVIOUSLY REPORTED?
Beschreibung

Non-ProtocolTherapyInd

Datentyp

text

Non-Protocol RT
Beschreibung

Non-ProtocolRTInd

Datentyp

text

Date of first non-protocol therapy
Beschreibung

Non-ProtocolTherapyDate,First

Datentyp

date

Non-Protocol Surgery
Beschreibung

Non-protocolSurgeryPerformedInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass-2
C1518384
Non-Protocol Chemotherapy
Beschreibung

Non-ProtocolChemotherapyInd

Datentyp

text

Other Non-Protocol therapy
Beschreibung

OtherNon-ProtocolTherapyInd

Datentyp

text

Specify other
Beschreibung

OtherNon-ProtocolTherapyName

Datentyp

text

Revised
Beschreibung

AmendedDataInd

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
IMT CODE TOXICITY CODE BASED ON CTEP TOXICITY TERM
Beschreibung

IMTCODETOXICITYCODEBASEDONCTEPTOXICITYTERM

Datentyp

text

TERM
Beschreibung

CTCAdverseEventTerm

Datentyp

text

GENERAL TOXICITY CATEGORY
Beschreibung

CTCAdverseEventCategory

Datentyp

text

SEVERITY GRADE
Beschreibung

CTCAdverseEventGrade

Datentyp

text

DATE OF 1ST OCCURRENCE OF GRADE=>3
Beschreibung

DATEOF1STOCCURRENCEOFGRADE=>3

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
ATTRIBUTION
Beschreibung

CTCAdverseEventAttributionCode

Datentyp

text

DESCRIPTION
Beschreibung

DESCRIPTION

Datentyp

text

HQ Use
Beschreibung

HQUse

Datentyp

text

Comments
Beschreibung

Comments

Comments
Beschreibung

Comments

Datentyp

text

Signature of Person Completing This Form
Beschreibung

SignatureofPersonCompletingThisForm

Datentyp

text

Date
Beschreibung

FormCompletionDate,Original

Datentyp

date

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No Instruction available.

1 Formulare
  1. StudyEvent: Radiation Therapy Oncology Group Initial Follow-up Form Phase III Lung Prophylactic Cranial RT
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header Module
Case#
Item
Case #
text
InstitutionName
Item
Institution
text
NCIInstitutionNumber
Item
Institution #
text
PatientName
Item
Patient Name
text
PatientID#
Item
Patient ID #
text
Item Group
Medical history
CancerFollow-upStatusDate
Item
DATE OF LAST CLINICAL ASSESSMENT
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
PATIENT'S VITAL STATUS
text
CL.1
Code List
PATIENT'S VITAL STATUS
CL Item
Alive (Alive)
CL Item
Dead (Dead)
CL Item
Lost (Lost)
CL Item
Unknown (Unknown)
DeathDate/LastContactDate
Item
LAST CONTACT DATE / DEATH DATE
date
Item
CAUSE OF DEATH
text
CL.2
Code List
CAUSE OF DEATH
CL Item
Related to or probably related to the cancer under study (Related to or probably related to the cancer under study)
CL Item
(whether local, regional, or distant) ((whether local, regional, or distant))
CL Item
Related to or probably related to a second primary tumor (Related to or probably related to a second primary tumor)
CL Item
Related to or probably related to complications of protocol treatment (Related to or probably related to complications of protocol treatment)
CL Item
(explain in COMMENTS, requires a grade 5 toxicity code) ((explain in COMMENTS, requires a grade 5 toxicity code))
CL Item
Related to or probably related to complications of other treatment (Related to or probably related to complications of other treatment)
CL Item
Other cause, specify (Other cause, specify)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DeathReason,Specify
Item
Cause of death, other specify
text
PerformanceStatus
Item
PERFORMANCE STATUS (ZUBROD)
text
ProgressionInd
Item
HAS THE PATIENT DEVELOPED A FIRST PROGRESSION NOT PREVIOUSLY REPORTED? (Complete Q6 A and B)
boolean
Item
Sites of progression, lung
text
CL.4
Code List
Sites of progression, lung
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown/not Evaluated (Unknown/not evaluated)
Item
Sites of progression, Lymph nodes (distant)
text
CL.5
Code List
Sites of progression, Lymph nodes (distant)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown/not Evaluated (Unknown/not evaluated)
Item
Sites of progression, pleural
text
CL.6
Code List
Sites of progression, pleural
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown/not Evaluated (Unknown/not evaluated)
Item
Sites of progression, adrenals
text
CL.7
Code List
Sites of progression, adrenals
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown/not Evaluated (Unknown/not evaluated)
Item
Sites of progression, liver
text
CL.8
Code List
Sites of progression, liver
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown/not Evaluated (Unknown/not evaluated)
Item
Sites of progression, bone
text
CL.9
Code List
Sites of progression, bone
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown/not Evaluated (Unknown/not evaluated)
Item
Sites of progression, CNS (Brain)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C12438 (NCI Thesaurus ObjectClass)
C0927232 (UMLS 2011AA ObjectClass)
CL.10
Code List
Sites of progression, CNS (Brain)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown/not Evaluated (Unknown/not evaluated)
ProgressionDate
Item
CNS (Brain) Date
date
Item
Sites of progression, Other Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ValueDomain-2)
C0205394 (UMLS 2011AA ValueDomain-2)
CL.11
Code List
Sites of progression, Other Specify
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Unknown/not Evaluated (Unknown/not evaluated)
ProgressionSite,Other
Item
Site of progression, other specify
text
ProgressionAssessmentMethod
Item
PROGRESSION ASSESSMENT
float
Item
HAS A NEW PRIMARY OR MDS BEEN DIAGNOSED THAT HAS NOT BEEN PREVIOUSLY REPORTED?
text
CL.13
Code List
HAS A NEW PRIMARY OR MDS BEEN DIAGNOSED THAT HAS NOT BEEN PREVIOUSLY REPORTED?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
NewPrimarySite
Item
NEW PRIMARY SITE
text
NewPrimary,HistologicType
Item
NEW PRIMARY HISTOLOGIC TYPE
text
NewPrimaryCancerDate
Item
DATE OF DIAGNOSIS
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
IS THE PATIENT RECEIVING ANY NON-PROTOCOL CANCER THERAPY NOT PREVIOUSLY REPORTED?
text
CL.14
Code List
IS THE PATIENT RECEIVING ANY NON-PROTOCOL CANCER THERAPY NOT PREVIOUSLY REPORTED?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Non-Protocol RT
text
CL.15
Code List
Non-Protocol RT
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Non-ProtocolTherapyDate,First
Item
Date of first non-protocol therapy
date
Item
Non-Protocol Surgery
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass-2)
CL.16
Code List
Non-Protocol Surgery
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Non-Protocol Chemotherapy
text
CL.17
Code List
Non-Protocol Chemotherapy
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Other Non-Protocol therapy
text
CL.18
Code List
Other Non-Protocol therapy
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
OtherNon-ProtocolTherapyName
Item
Specify other
text
AmendedDataInd
Item
Revised
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
IMTCODETOXICITYCODEBASEDONCTEPTOXICITYTERM
Item
IMT CODE TOXICITY CODE BASED ON CTEP TOXICITY TERM
text
CTCAdverseEventTerm
Item
TERM
text
Item
GENERAL TOXICITY CATEGORY
text
CL.19
Code List
GENERAL TOXICITY CATEGORY
CL Item
Allergy / Immunology (Allergy / Immunology)
CL Item
Auditory/Hearing (Auditory/Hearing)
CL Item
Blood/Bone marrow (Blood/Bone marrow)
CL Item
Cardiovascular (Arrhythmia) (Cardiovascular (Arrhythmia))
CL Item
Cardiovascular (General) (Cardiovascular (General))
CL Item
Coagulation (Coagulation)
CL Item
Constitutional Symptoms (Constitutional Symptoms)
CL Item
Dermatology/Skin (Dermatology/Skin)
CL Item
Endocrine (Endocrine)
CL Item
Gastrointestinal (Gastrointestinal)
CL Item
Hemorrhage (Hemorrhage)
CL Item
Hepatic (Hepatic)
CL Item
Infection/Febrile Neutropenia (Infection/Febrile Neutropenia)
CL Item
Lymphatics (Lymphatics)
CL Item
Metabolic/Laboratory (Metabolic/Laboratory)
CL Item
Musculoskeletal (Musculoskeletal)
CL Item
Neurology (Neurology)
CL Item
Ocular/Visual (Ocular/Visual)
CL Item
Pain (Pain)
CL Item
Pulmonary (Pulmonary)
CL Item
Renal/Genitourinary (Renal/Genitourinary)
CL Item
Second Malignancy (Second Malignancy)
CL Item
Sexual/Reproductive Function (Sexual/Reproductive Function)
CL Item
Syndromes (Syndromes)
CTCAdverseEventGrade
Item
SEVERITY GRADE
text
DATEOF1STOCCURRENCEOFGRADE=>3
Item
DATE OF 1ST OCCURRENCE OF GRADE=>3
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
ATTRIBUTION
text
CL.20
Code List
ATTRIBUTION
CL Item
Radiotherapy only (Brain) (Radiotherapy only (Brain))
CL Item
Other cause, specify in "Description" (Other cause, specify in "Description")
CL Item
Unknown (Unknown)
DESCRIPTION
Item
DESCRIPTION
text
HQUse
Item
HQ Use
text
Item Group
Comments
Comments
Item
Comments
text
SignatureofPersonCompletingThisForm
Item
Signature of Person Completing This Form
text
FormCompletionDate,Original
Item
Date
date
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