ID

10557

Beschreibung

T1 Radiation Therapy Oncology Group Phase III Randomized Study of Intermediate Risk Prostate Cancer Radiotherapy Form NCT00063882 Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AA89543F-5C0D-58C5-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AA89543F-5C0D-58C5-E034-0003BA12F5E7

Stichworte

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

3. Juni 2015

DOI

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T1 Radiation Therapy Oncology Group Phase III Randomized Study of Intermediate Risk Prostate Cancer Radiotherapy Form NCT00063882

Englisch

INSTRUCTIONS: Submit this form at the completion of protocol therapy. Use -1 for unknown or not applicable unless otherwise specified in the codetable. All dates to be reported mm-dd-yyyy unless otherwise indicated. A copy must be submitted to the RTOG

1 Formulare  
Header Module
Beschreibung

Header Module

If this is a revised or corrected form, indicate by checking box
Beschreibung

AmendedDataInd

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
RTOG clinical trial administrative data
Beschreibung

RTOG clinical trial administrative data

RTOG Study
Beschreibung

RTOGStudy

Datentyp

text

Case #
Beschreibung

Case#

Datentyp

text

Institution Name
Beschreibung

InstitutionName

Datentyp

text

Institution No.
Beschreibung

NCIInstitutionNumber

Datentyp

text

Patient's Name
Beschreibung

PatientName,First

Datentyp

text

Patient's I.D. No.
Beschreibung

PatientStudyID,RegisteringGroup

Datentyp

text

RADIOTHERAPY documentation
Beschreibung

RADIOTHERAPY documentation

RADIATION THERAPY START DATE (External Beam)
Beschreibung

RTBeginDate

Datentyp

date

RADIATION THERAPY END DATE (External Beam)
Beschreibung

RTEndDate

Datentyp

date

TOTAL DOSE (Gy)
Beschreibung

RTTotalDose

Datentyp

float

WERE THERE ANY UNSCHEDULED INTERRUPTIONS IN RADIATION THERAPY (External Beam)
Beschreibung

RTInterruptionsInd

Datentyp

text

Specify RT interruption reason
Beschreibung

RadiationTherapyUnscheduledInterruptionSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C25211
UMLS 2011AA Property-2
C0086960
NCI Thesaurus Property-3
C25542
UMLS 2011AA Property-3
C1512900
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
REASON EXTERNAL RADIATION THERAPY TREATMENT ENDED
Beschreibung

OffTreatmentReason

Datentyp

text

Alternative therapy, specify
Beschreibung

Alternativetherapy,specify(reasonradiationtherapyended)

Datentyp

text

Other complicating disease, specify
Beschreibung

OffTreatmentReason,ComplicatingDisease

Datentyp

text

Other, specify
Beschreibung

Other,specify

Datentyp

text

DID TREATMENT INCLUDE IMRT
Beschreibung

Intensity-ModulatedRadiationTherapyAdministrationInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16135
UMLS 2011AA ObjectClass
C1512814
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
IF BRACHYTHERAPY NOT UTILIZED, PROVIDE REASON
Beschreibung

BrachytherapyOff-TreatmentReason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus Property
C25601
UMLS 2011AA Property
C1518544
NCI Thesaurus ObjectClass
C15195
UMLS 2011AA ObjectClass
C0006098
specify Rx (alternative Rx given)
Beschreibung

specifyRx(alternativeRxgiven)

Datentyp

text

Other reason, specify
Beschreibung

Other,specify(reasontreatmentended)

Datentyp

text

ISOTOPE TYPE
Beschreibung

ISOTOPETYPE

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
DATE OF PRE-IMPLANT TRUS STUDY
Beschreibung

DATEOFPRE-IMPLANTTRUSSTUDY

Datentyp

text

DATE OF IMPLANT
Beschreibung

DATEOFIMPLANT

Datentyp

text

DATE OF POST-IMPLANT CT (BASIC DOSIMETRY INFORMATION)
Beschreibung

CTPostBrachytherapyDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C17204
UMLS 2011AA ObjectClass
C0040405
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Metathesaurus Property
CL054378
AVERAGE ACTIVITY PER SEED AS MEASURED BY INSTITUTION (Activity)
Beschreibung

AVERAGEACTIVITYPERSEEDASMEASUREDBYINSTITUTION

Datentyp

text

Date
Beschreibung

AssessmentDate

Datentyp

date

MIDPOINT APPARENT ACTIVITY STATED BY THE VENDOR (Activity)
Beschreibung

MIDPOINTAPPARENTACTIVITYSTATEDBYTHEVENDOR

Datentyp

text

NUMBER OF SEEDS USED
Beschreibung

NUMBEROFSEEDSUSED

Datentyp

text

NUMBER OF NEEDLES USED
Beschreibung

NUMBEROFNEEDLESUSED

Datentyp

text

SEED LOSS (were seeds expelled within the 3 weeks of implant? If yes, report details in Comments section)
Beschreibung

BrachytherapyRadioactiveSeedImplantDosingUnitLostInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25560
UMLS 2011AA Property
C0745777
NCI Thesaurus Property-2
C67446
UMLS 2011AA Property-2
C1882540
NCI Thesaurus ObjectClass
C15195
UMLS 2011AA ObjectClass
C0006098
WERE DOSE VOLUME HISTOGRAMS DONE
Beschreibung

WEREDOSEVOLUMEHISTOGRAMSDONE

Datentyp

text

WAS AN INDWELLING URINARY CATHETER INSERTED SINCE IMPLANT
Beschreibung

SurgicalProcedureCatheterUrethraPostBrachytherapyPerformedTherapyInd-3

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C38008
UMLS 2011AA Property-2
C0687676
NCI Thesaurus Property-3
C15195
UMLS 2011AA Property-3
C0006098
NCI Thesaurus Property-4
C17446
UMLS 2011AA Property-4
C0085590
NCI Thesaurus Property-5
C12417
UMLS 2011AA Property-5
C0041967
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
DATE INSERTED (Provide estimate if exact date unknown)
Beschreibung

DATEINSERTED

Datentyp

text

DATE REMOVED (Provide estimate if exact date unknown)
Beschreibung

DATEREMOVED

Datentyp

text

Footer module
Beschreibung

Footer module

COMMENTS
Beschreibung

Comments

Datentyp

text

Signature
Beschreibung

Signature

Datentyp

text

Date
Beschreibung

FormCompletionDate,Original

Datentyp

date

Ccrr Module For T1 Radiation Therapy Oncology Group Phase Iii Randomized Study Of Intermediate Risk Prostate Cancer Radiotherapy Form
Beschreibung

Ccrr Module For T1 Radiation Therapy Oncology Group Phase Iii Randomized Study Of Intermediate Risk Prostate Cancer Radiotherapy Form

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Ähnliche Modelle

INSTRUCTIONS: Submit this form at the completion of protocol therapy. Use -1 for unknown or not applicable unless otherwise specified in the codetable. All dates to be reported mm-dd-yyyy unless otherwise indicated. A copy must be submitted to the RTOG

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header Module
AmendedDataInd
Item
If this is a revised or corrected form, indicate by checking box
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Item Group
RTOG clinical trial administrative data
RTOGStudy
Item
RTOG Study
text
Case#
Item
Case #
text
InstitutionName
Item
Institution Name
text
NCIInstitutionNumber
Item
Institution No.
text
PatientName,First
Item
Patient's Name
text
PatientStudyID,RegisteringGroup
Item
Patient's I.D. No.
text
Item Group
RADIOTHERAPY documentation
RTBeginDate
Item
RADIATION THERAPY START DATE (External Beam)
date
RTEndDate
Item
RADIATION THERAPY END DATE (External Beam)
date
RTTotalDose
Item
TOTAL DOSE (Gy)
float
Item
WERE THERE ANY UNSCHEDULED INTERRUPTIONS IN RADIATION THERAPY (External Beam)
text
CL.1
Code List
WERE THERE ANY UNSCHEDULED INTERRUPTIONS IN RADIATION THERAPY (External Beam)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Due To Toxicity (Yes, due to toxicity)
CL Item
Yes, For Other Reasons, Specify (Yes, due to other reason)
RadiationTherapyUnscheduledInterruptionSpecify
Item
Specify RT interruption reason
text
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25211 (NCI Thesaurus Property-2)
C0086960 (UMLS 2011AA Property-2)
C25542 (NCI Thesaurus Property-3)
C1512900 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
REASON EXTERNAL RADIATION THERAPY TREATMENT ENDED
text
CL.2
Code List
REASON EXTERNAL RADIATION THERAPY TREATMENT ENDED
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Toxicity/side Effects/complications (Toxicity/side effects/complications)
CL Item
Death On Study (Death on study)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
Alternative Therapy (Alternative therapy, specify)
CL Item
Other (Other complicating disease, specify)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other, Specify (Other, specify)
Alternativetherapy,specify(reasonradiationtherapyended)
Item
Alternative therapy, specify
text
OffTreatmentReason,ComplicatingDisease
Item
Other complicating disease, specify
text
Other,specify
Item
Other, specify
text
Intensity-ModulatedRadiationTherapyAdministrationInd-3
Item
DID TREATMENT INCLUDE IMRT
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16135 (NCI Thesaurus ObjectClass)
C1512814 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
Item
IF BRACHYTHERAPY NOT UTILIZED, PROVIDE REASON
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
CL.4
Code List
IF BRACHYTHERAPY NOT UTILIZED, PROVIDE REASON
CL Item
Na Dose Administered Within Protocol Specifications (NA Dose administered within protocol specifications)
CL Item
Not Technically Feasible (Not technically feasible)
CL Item
Patient Refused (Patient refused)
CL Item
Inadequate To Treat Extent Of Disease (Inadequate to treat extent of disease)
CL Item
Md Preference (MD preference)
CL Item
Progression Or Relapse (Progression or relapse)
CL Item
Toxicity Or Treatment Reaction (Toxicity or treatment reaction)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Alternative Rx Given, Specify Rx (Alternative Rx given, specify Rx)
CL Item
Other Reason, Specify (Other reason, specify)
specifyRx(alternativeRxgiven)
Item
specify Rx (alternative Rx given)
text
Other,specify(reasontreatmentended)
Item
Other reason, specify
text
Item
ISOTOPE TYPE
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.5
Code List
ISOTOPE TYPE
CL Item
I-125 (I-125)
CL Item
Pd-103 (Pd-103)
CL Item
Other, Specify (Other, specify)
DATEOFPRE-IMPLANTTRUSSTUDY
Item
DATE OF PRE-IMPLANT TRUS STUDY
text
DATEOFIMPLANT
Item
DATE OF IMPLANT
text
CTPostBrachytherapyDate
Item
DATE OF POST-IMPLANT CT (BASIC DOSIMETRY INFORMATION)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
CL054378 (NCI Metathesaurus Property)
AVERAGEACTIVITYPERSEEDASMEASUREDBYINSTITUTION
Item
AVERAGE ACTIVITY PER SEED AS MEASURED BY INSTITUTION (Activity)
text
AssessmentDate
Item
Date
date
MIDPOINTAPPARENTACTIVITYSTATEDBYTHEVENDOR
Item
MIDPOINT APPARENT ACTIVITY STATED BY THE VENDOR (Activity)
text
NUMBEROFSEEDSUSED
Item
NUMBER OF SEEDS USED
text
NUMBEROFNEEDLESUSED
Item
NUMBER OF NEEDLES USED
text
Item
SEED LOSS (were seeds expelled within the 3 weeks of implant? If yes, report details in Comments section)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25560 (NCI Thesaurus Property)
C0745777 (UMLS 2011AA Property)
C67446 (NCI Thesaurus Property-2)
C1882540 (UMLS 2011AA Property-2)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
CL.6
Code List
SEED LOSS (were seeds expelled within the 3 weeks of implant? If yes, report details in Comments section)
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
WERE DOSE VOLUME HISTOGRAMS DONE
text
CL.7
Code List
WERE DOSE VOLUME HISTOGRAMS DONE
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
WAS AN INDWELLING URINARY CATHETER INSERTED SINCE IMPLANT
text
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C15195 (NCI Thesaurus Property-3)
C0006098 (UMLS 2011AA Property-3)
C17446 (NCI Thesaurus Property-4)
C0085590 (UMLS 2011AA Property-4)
C12417 (NCI Thesaurus Property-5)
C0041967 (UMLS 2011AA Property-5)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.8
Code List
WAS AN INDWELLING URINARY CATHETER INSERTED SINCE IMPLANT
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)
DATEINSERTED
Item
DATE INSERTED (Provide estimate if exact date unknown)
text
DATEREMOVED
Item
DATE REMOVED (Provide estimate if exact date unknown)
text
Item Group
Footer module
Comments
Item
COMMENTS
text
Signature
Item
Signature
text
FormCompletionDate,Original
Item
Date
date
Item Group
Ccrr Module For T1 Radiation Therapy Oncology Group Phase Iii Randomized Study Of Intermediate Risk Prostate Cancer Radiotherapy Form
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