ID

10071

Description

F1 Radiation Therapy Oncology Group Phase III Randomized Study of Intermediate Risk Prostate Cancer Follow-up Form Late RT Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer NCT00063882 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AA8904F6-5E04-5881-E034-0003BA12F5E7

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AA8904F6-5E04-5881-E034-0003BA12F5E7

Mots-clés

Versions (2)
  1. 19/09/2012 19/09/2012 -
  2. 23/03/2015 23/03/2015 - Martin Dugas
Téléchargé le

23 mars 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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Prostate Cancer NCT00063882

Anglais

INSTRUCTIONS: Submit this form at the appropriate followup interval. Use -1 for unknown or not applicable unless otherwise specified in codetable. All dates to be reported mm-dd-yyyy unless otherwise indicated.

1 Formulaires  
Header
Description

Header

RTOG Study
Description

RTOGStudy

Type de données

text

Case #
Description

Case#

Type de données

text

Institution Name
Description

InstitutionName

Type de données

text

Institution No.
Description

NCIInstitutionNumber

Type de données

text

Patient Name, Last
Description

PatientName,Last

Type de données

text

Patient Name, First
Description

PatientName,First

Type de données

text

AMENDED DATA
Description

AmendedDataInd

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
DATE FROM (Q2)
Description

IntervalReportFromDate

Type de données

date

COMMENTS
Description

Comments

Type de données

text

SIGNATURE
Description

SignatureofPersonCompletingThisForm

Type de données

text

DATE
Description

FormCompletionDate,Original

Type de données

date

Cancer Follow-up Status
Description

Cancer Follow-up Status

Alias
UMLS CUI-1
C0478532
PATIENT'S VITAL STATUS
Description

Patient'sVitalStatus

Type de données

text

DATE OF LAST CONTACT OR DEATH
Description

DeathDate/LastContactDate

Type de données

date

CAUSE OF DEATH
Description

CAUSE OF DEATH

Type de données

text

Alias
UMLS CUI-1
C0007465
Due to other cause, specify (cause of death)
Description

DeathCauseText

Type de données

text

Alias
NCI Thesaurus Property
C25638
UMLS 2011AA Property
C0392360
NCI Thesaurus ObjectClass
C28554
UMLS 2011AA ObjectClass
C0011065
NCI Thesaurus Property-2
C25251
UMLS 2011AA Property-2
C0205225
HAS THE PATIENT HAD A DOCUMENTED CLINICAL ASSESSMENT FOR PROSTATE CANCER SINCE SUBMISSION OF THE PREVIOUS FOLLOWUP FORM?
Description

CancerFollow-upStatusInd

Type de données

text

DATE OF LAST CLINICAL ASSESSMENT
Description

CancerFollow-upStatusDate

Type de données

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
PERFORMANCE STATUS (ZUBROD)
Description

PerformanceStatus

Type de données

text

Follow-up PSA Value(s)
Description

PSAValue

Type de données

float

Alias
UMLS CUI-1
C0138741
Date of PSA Assessment(s)
Description

PSADate

Type de données

date

HAS THE PATIENT HAD A PROSTATE BIOPSY SINCE SUBMISSION OF THE LAST FOLLOWUP FORM?
Description

HASTHEPATIENTHADAPROSTATEBIOPSYSINCESUBMISSIONOFTHELASTFOLLOWUPFORM?

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25180
UMLS CUI-1
C0194804
Biopsy Date
Description

Biopsy Date

Type de données

date

Alias
UMLS CUI-1
C0011008
UMLS CUI-2
C0005558
HAS THE PATIENT DEVELOPED A FIRST PROGRESSION THAT HAS NOT BEEN PREVIOUSLY REPORTED?
Description

ProgressionInd

Type de données

text

HAS THE PATIENT BEEN DIAGNOSED WITH BIOCHEMICAL RECURRENCE SINCE SUBMISSION OF LAST FOLLOW-UP FORM? (See Protocol Section 11)
Description

ProgressionInd,Biochemical

Type de données

text

Date of first biochemical progression
Description

ProgressionDate,FirstBiochemical

Type de données

date

PSA Value at progression
Description

ProgressionPSAValue

Type de données

float

HAS THE PATIENT BEEN DIAGNOSED WITH FIRST LOCAL-REGIONAL RECURRENCE SINCE SUBMISSION OF LAST FOLLOW-UP FORM? (See Protocol Section 11)
Description

ProgressionInd,FirstLocal-Regional

Type de données

text

Date of First Local-Regional Progression
Description

ProgressionDate,FirstLocal-Regional

Type de données

date

Site(s) of Local/Regional Progression
Description

ProgressionSite

Type de données

text

WHAT WAS THE METHOD USED TO DETERMINE distant PROGRESSION
Description

AssessmentType

Type de données

text

Other, specify (method used to determine distant progression)
Description

AssessmentType,Specify

Type de données

text

HAS THE PATIENT BEEN DIAGNOSED WITH FIRST DISTANT RECURRENCE SINCE SUBMISSION OF THE LAST FOLLOW-UP FORM?
Description

ProgressionInd,FirstDistant

Type de données

text

Date of First Distant Progression
Description

ProgressionDate,FirstDistant

Type de données

date

Site(s) of First Distant Progression
Description

ProgressionSite,FirstDistant

Type de données

text

DID THE PATIENT RECEIVE ANY NON-PROTOCOL PROSTATE CANCER THERAPY SINCE THE LAST FOLLOW-UP (If yes, enter therapy type and date for each therapy delivered during the follow-up period.)
Description

Non-ProtocolTherapyInd

Type de données

boolean

Alias
UMLS CUI-1
C1518384
UMLS CUI-2
C0087111
Non-Protocol Therapy Type
Description

Non-ProtocolTherapyAdministeredType

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Radiation to other sites, specify
Description

Radiationtoothersites,specify

Type de données

text

Other, specify
Description

Other,specify

Type de données

text

Surgical procedure related to previous RT, specify
Description

SurgicalprocedurerelatedtopreviousRT,specify

Type de données

text

Date of first non-protocol therapy
Description

Non-ProtocolTherapyDate,First

Type de données

date

Specify (non-protocol prostate cancer therapy) (HAS A NEW PRIMARY CANCER OR MDS MYELODYSPLASTIC SYNDROME BEEN DIAGNOSED THAT HAS NOT BEEN PREVIOUSLY REPORTED?)
Description

Specify(non-protocolprostatecancertherapy)

Type de données

text

New Primary Site
Description

NewPrimarySite

Type de données

text

New Primary Site
Description

NewCancerDiagnosisAnatomicSite

Type de données

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
New Primary Cancer Date
Description

NewPrimaryCancerDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Specify (new primary site)
Description

Specify(newprimarysite)

Type de données

text

LATE RADIATION THERAPY ADVERSE EVENTS
Description

LateAdverseEventInd REPORT ANY NEW OR CONTINUING EVENTS WHICH BEGAN >180 DAYS FROM THE START OF RT. If the toxicity is new, record the date it first appeared. Do not report tumor effects or those from non-protocol treatment or intercurrent disease. Code the most severe grade noted. USE THE RTOG/EORTC LATE RADIATION MORBIDITY SCORING SCHEMA Appendix IV. 8 = not evaluable, 9 = unknown, -1 = not applicable. If toxicity is grade 3 or greater, give detailed description of toxicity and provide any treatment given in the comments section.

Type de données

boolean

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0205087
Late RT Adverse Event Grade
Description

LateAdverseEventGrade

Type de données

text

Late RT Adverse Event Term
Description

LateAdverseEventTerm

Type de données

text

BLADDER/OTHER GU Specify (late adverse event)
Description

BLADDER/OTHERGUSpecify(lateadverseevent)

Type de données

text

SMALL/LARGE INTESTINE, specify (late adverse event)
Description

SMALL/LARGEINTESTINE,specify(lateadverseevent)

Type de données

text

OTHER GI, specify (late adverse event)
Description

OTHERGI,specify(lateadverseevent)

Type de données

text

OTHER, specify (late adverse event)
Description

OTHER,specify(lateadverseevent)

Type de données

text

Late RT Adverse Event Onset Date
Description

LateAdverseEventOnsetDate

Type de données

date

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Similar models

INSTRUCTIONS: Submit this form at the appropriate followup interval. Use -1 for unknown or not applicable unless otherwise specified in codetable. All dates to be reported mm-dd-yyyy unless otherwise indicated.

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Header
RTOGStudy
Item
RTOG Study
text
Case#
Item
Case #
text
InstitutionName
Item
Institution Name
text
NCIInstitutionNumber
Item
Institution No.
text
PatientName,Last
Item
Patient Name, Last
text
PatientName,First
Item
Patient Name, First
text
AmendedDataInd
Item
AMENDED DATA
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
IntervalReportFromDate
Item
DATE FROM (Q2)
date
Comments
Item
COMMENTS
text
SignatureofPersonCompletingThisForm
Item
SIGNATURE
text
FormCompletionDate,Original
Item
DATE
date
Item Group
Cancer Follow-up Status
C0478532 (UMLS CUI-1)
Item
PATIENT'S VITAL STATUS
text
CL.1
Code List
PATIENT'S VITAL STATUS
CL Item
Alive (Alive)
CL Item
Dead (Dead)
DeathDate/LastContactDate
Item
DATE OF LAST CONTACT OR DEATH
date
Item
CAUSE OF DEATH
text
C0007465 (UMLS CUI-1)
CL.2
Code List
CAUSE OF DEATH
CL Item
N/A (N/A)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To Other Cause (Due to other cause, specify)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DeathCauseText
Item
Due to other cause, specify (cause of death)
text
C25638 (NCI Thesaurus Property)
C0392360 (UMLS 2011AA Property)
C28554 (NCI Thesaurus ObjectClass)
C0011065 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus Property-2)
C0205225 (UMLS 2011AA Property-2)
Item
HAS THE PATIENT HAD A DOCUMENTED CLINICAL ASSESSMENT FOR PROSTATE CANCER SINCE SUBMISSION OF THE PREVIOUS FOLLOWUP FORM?
text
CL.3
Code List
HAS THE PATIENT HAD A DOCUMENTED CLINICAL ASSESSMENT FOR PROSTATE CANCER SINCE SUBMISSION OF THE PREVIOUS FOLLOWUP FORM?
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)
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)
PerformanceStatus
Item
PERFORMANCE STATUS (ZUBROD)
text
PSA
Item
Follow-up PSA Value(s)
float
C0138741 (UMLS CUI-1)
PSADate
Item
Date of PSA Assessment(s)
date
Prostate biopsy
Item
HAS THE PATIENT HAD A PROSTATE BIOPSY SINCE SUBMISSION OF THE LAST FOLLOWUP FORM?
boolean
C25704 (NCI Thesaurus ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C0194804 (UMLS CUI-1)
BiopsyDate
Item
Biopsy Date
date
C0011008 (UMLS CUI-1)
C0005558 (UMLS CUI-2)
Item
HAS THE PATIENT DEVELOPED A FIRST PROGRESSION THAT HAS NOT BEEN PREVIOUSLY REPORTED?
text
CL.5
Code List
HAS THE PATIENT DEVELOPED A FIRST PROGRESSION 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)
Item
HAS THE PATIENT BEEN DIAGNOSED WITH BIOCHEMICAL RECURRENCE SINCE SUBMISSION OF LAST FOLLOW-UP FORM? (See Protocol Section 11)
text
CL.6
Code List
HAS THE PATIENT BEEN DIAGNOSED WITH BIOCHEMICAL RECURRENCE SINCE SUBMISSION OF LAST FOLLOW-UP FORM? (See Protocol Section 11)
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)
ProgressionDate,FirstBiochemical
Item
Date of first biochemical progression
date
ProgressionPSAValue
Item
PSA Value at progression
float
Item
HAS THE PATIENT BEEN DIAGNOSED WITH FIRST LOCAL-REGIONAL RECURRENCE SINCE SUBMISSION OF LAST FOLLOW-UP FORM? (See Protocol Section 11)
text
CL.7
Code List
HAS THE PATIENT BEEN DIAGNOSED WITH FIRST LOCAL-REGIONAL RECURRENCE SINCE SUBMISSION OF LAST FOLLOW-UP FORM? (See Protocol Section 11)
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)
ProgressionDate,FirstLocal-Regional
Item
Date of First Local-Regional Progression
date
ProgressionSite
Item
Site(s) of Local/Regional Progression
text
Item
WHAT WAS THE METHOD USED TO DETERMINE distant PROGRESSION
text
CL.10
Code List
WHAT WAS THE METHOD USED TO DETERMINE distant PROGRESSION
CL Item
Clinical Examination (Physical exam)
CL Item
Pathologic (Pathologic)
CL Item
Radiographic (Radiographic)
CL Item
Nuclear scan (Nuclear scan)
CL Item
Other (Other, specify)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AssessmentType,Specify
Item
Other, specify (method used to determine distant progression)
text
Item
HAS THE PATIENT BEEN DIAGNOSED WITH FIRST DISTANT RECURRENCE SINCE SUBMISSION OF THE LAST FOLLOW-UP FORM?
text
CL.9
Code List
HAS THE PATIENT BEEN DIAGNOSED WITH FIRST DISTANT RECURRENCE SINCE SUBMISSION OF THE LAST FOLLOW-UP FORM?
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)
ProgressionDate,FirstDistant
Item
Date of First Distant Progression
date
ProgressionSite,FirstDistant
Item
Site(s) of First Distant Progression
text
Non-protocol Therapy
Item
DID THE PATIENT RECEIVE ANY NON-PROTOCOL PROSTATE CANCER THERAPY SINCE THE LAST FOLLOW-UP (If yes, enter therapy type and date for each therapy delivered during the follow-up period.)
boolean
C1518384 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Item
Non-Protocol Therapy Type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.12
Code List
Non-Protocol Therapy Type
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Radiation To Pelvis (Radiation to pelvis)
CL Item
Radiation To Other Sites, Specify (Radiation to other sites, specify)
CL Item
Surgery (Surgery)
C17173 (NCI Thesaurus)
C0038894 (UMLS 2011AA)
CL Item
Chemotherapy (Chemotherapy)
C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)
CL Item
Hormones (Hormones)
CL Item
Other Specify (Other, specify)
CL Item
Surgical Procedure Related To Previous Rt, Specify (Surgical procedure related to previous RT, specify)
Radiationtoothersites,specify
Item
Radiation to other sites, specify
text
Other,specify
Item
Other, specify
text
SurgicalprocedurerelatedtopreviousRT,specify
Item
Surgical procedure related to previous RT, specify
text
Non-ProtocolTherapyDate,First
Item
Date of first non-protocol therapy
date
Specify(non-protocolprostatecancertherapy)
Item
Specify (non-protocol prostate cancer therapy) (HAS A NEW PRIMARY CANCER OR MDS MYELODYSPLASTIC SYNDROME BEEN DIAGNOSED THAT HAS NOT BEEN PREVIOUSLY REPORTED?)
text
Item
New Primary Site
text
CL.13
Code List
New Primary Site
CL Item
None (None)
CL Item
AML/MDS (AML/MDS)
CL Item
BCC (BCC)
CL Item
Bladder (Bladder)
CL Item
Brain (Brain)
CL Item
Colorectal (Colorectal)
CL Item
Esophageal (Esophageal)
CL Item
Gastric (Gastric)
CL Item
Liver (Liver)
CL Item
Lung (Lung)
CL Item
Melanoma (Melanoma)
CL Item
NHL (NHL)
CL Item
Pancreatic (Pancreatic)
CL Item
Renal (Renal)
CL Item
Squamous-Skin (Squamous-Skin)
CL Item
Other Hematologic, specify (Other Hematologic, specify)
CL Item
Other solid, specify (Other solid, specify)
CL Item
Unknown primary (Unknown primary)
NewCancerDiagnosisAnatomicSite
Item
New Primary Site
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
NewPrimaryCancerDate
Item
New Primary Cancer Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Specify(newprimarysite)
Item
Specify (new primary site)
text
Late adverse event
Item
LATE RADIATION THERAPY ADVERSE EVENTS
boolean
C0877248 (UMLS CUI-1)
C0205087 (UMLS CUI-2)
LateAdverseEventGrade
Item
Late RT Adverse Event Grade
text
Item
Late RT Adverse Event Term
text
CL.15
Code List
Late RT Adverse Event Term
CL Item
SKIN (SKIN)
CL Item
BLADDER/OTHER GU Specify (BLADDER/OTHER GU Specify)
CL Item
SMALL/LARGE INTESTINE, specify (SMALL/LARGE INTESTINE, specify)
CL Item
OTHER GI, specify (OTHER GI, specify)
CL Item
OTHER, specify (OTHER, specify)
bladder late adverse event
Item
BLADDER/OTHER GU Specify (late adverse event)
text
intestine late adverse event
Item
SMALL/LARGE INTESTINE, specify (late adverse event)
text
OTHERGI,specify(lateadverseevent)
Item
OTHER GI, specify (late adverse event)
text
OTHER,specify(lateadverseevent)
Item
OTHER, specify (late adverse event)
text
LateAdverseEventOnsetDate
Item
Late RT Adverse Event Onset Date
date
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