ID

8208

Description

RTOG 1115 T1: Phase III RT + Standard ADT vs RT + Enhanced ADT + TAK-700 Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AE8E92E1-C7D4-6523-E040-BB89AD436A37

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AE8E92E1-C7D4-6523-E040-BB89AD436A37

Keywords

  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Prostate Cancer NCT01546987 Treatment - RTOG 1115 T1: Phase III RT + Standard ADT vs RT + Enhanced ADT + TAK-700 - 3289078v1.0

Instructions: Form is submitted upon completion or termination of RT for all patients assigned RT. Dates are mmdd-yyyy unless specified otherwise. If assigned radiation and none given, complete Q#7, sign date and submit form.

Unnamed Module 1
Description

Unnamed Module 1

RTOG Study No.
Description

Protocol ID RTOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1514695
NCI Thesaurus Property
C19778
NCI Thesaurus Property-2
C25364
Case #
Description

RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C19778
UMLS 2011AA ObjectClass-2
C1514695
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C49152
UMLS 2011AA Property-2
C1706256
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Institution Name
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Institution No.
Description

Institution Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Patient Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
RTOG Patient ID
Description

Trial subject ID RTOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1514695
NCI Thesaurus Property
C19778
NCI Thesaurus Property-2
C25364
Amended data
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Module 1
Description

Module 1

Radiation Therapy Start Date
Description

Radiation Therapy Start Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C15313
UMLS CUI-1
C1522449
NCI Thesaurus Property
C25431
UMLS CUI-2
C0808070
NCI Thesaurus Property-2
C25275
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Radiation Therapy End Date
Description

Radiation Therapy End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1522449
NCI Thesaurus ObjectClass
C15313
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25275
NCI Thesaurus Property-2
C25496
RT Total Fraction Count
Description

Total Number of Fractions

Data type

float

Alias
NCI Thesaurus Property
C25304
UMLS CUI-1
C1522449
NCI Thesaurus ObjectClass
C15313
UMLS CUI-2
C1264633
NCI Thesaurus ValueDomain
C25463
UMLS CUI-3
C0750480
NCI Thesaurus Property-2
C25514
RT Total Dose (TO PTV)
Description

Radiation Therapy Total Dose

Data type

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2169193
NCI Thesaurus ObjectClass
C15313
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus Property
C25382
Total elapsed days (INCLUDING BOTH EXTERNAL RADIATION THERAPY AND BRACHYTHERAPY)
Description

RadiationTherapyTotalDayCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25304
UMLS 2011AA Property
C0439810
NCI Thesaurus Property-2
C25301
UMLS 2011AA Property-2
C0439228
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
Were there any unscheduled interruptions in radiation therapy? (EXCLUDING HOLIDAYS)
Description

Unscheduled Interruptions in Radiation Therapy

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1522449
NCI Thesaurus ObjectClass
C15313
UMLS CUI-2
C1512900
NCI Thesaurus Property
C25542
Specify RT interruption reason
Description

Radiation Therapy Interruption Reason

Data type

text

Alias
NCI Thesaurus ObjectClass
C15313
UMLS CUI-1
C1522449
NCI Thesaurus Property
C25594
UMLS CUI-2
C3538832
NCI Thesaurus Property-2
C25211
NCI Thesaurus Property-3
C25542
NCI Thesaurus ValueDomain
C25685
Reason Treatment Ended
Description

Off Treatment Reason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Alternative Therapy, specify
Description

Off-treatmentAlternativeReasonSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25415
UMLS 2011AA Property
C1523987
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
Other specify
Description

Off Treatment Reason, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
UMLS CUI-3
C1521902
Type of Radiation Therapy Administered
Description

Radiation Therapy Type

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1522449
NCI Thesaurus ObjectClass
C15313
UMLS CUI-2
C0683312
NCI Thesaurus Property
C25382
What method of daily prostate localization was used
Description

DailyLocalizationProstateMethodType

Data type

text

Alias
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Metathesaurus ObjectClass
CL052062
NCI Thesaurus ObjectClass-2
C28264
UMLS 2011AA ObjectClass-2
C0475264
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify
Description

DailyLocalizationProstateMethodSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Metathesaurus ObjectClass
CL052062
NCI Thesaurus ObjectClass-2
C28264
UMLS 2011AA ObjectClass-2
C0475264
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Brachytherapy
Description

Brachytherapy

IF BRACHYTHERAPY NOT UTILIZED, PROVIDE REASON
Description

BrachytherapyOff-TreatmentReason

Data type

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 therapy
Description

Alternative therapy, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0949216
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25415
NCI Thesaurus Property
C25382
Other reason, specify
Description

BrachytherapyOffTreatmentReasonSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C25601
UMLS 2011AA Property
C1518544
NCI Thesaurus ObjectClass
C15195
UMLS 2011AA ObjectClass
C0006098
Low-dose Radiation
Description

Low-dose Radiation

Date of implant
Description

BrachytherapyImplantDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15195
UMLS 2011AA ObjectClass
C0006098
NCI Thesaurus Property
C17948
UMLS 2011AA Property
C0013183
Date of post-implant CT
Description

CTPostBrachytherapyDate

Data type

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
Seed loss (were seeds expelled within the 3 weeks of implant? If yes, report details in Comment section.)
Description

BrachytherapyRadioactiveSeedImplantDosingUnitLostInd-3

Data type

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
Was an indwelling urinary catheter inserted since implant
Description

SurgicalProcedureCatheterUrethraPostBrachytherapyPerformedTherapyInd-3

Data type

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)
Description

SurgicalProcedureCatheterUrethraPostBrachytherapyPerformedDate

Data type

date

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
C25164
UMLS 2011AA ValueDomain
C0011008
Date removed (Provide estimate if exact date unknown)
Description

SurgicalProcedureCatheterUrethraPostBrachytherapyRemovePerformedDate

Data type

date

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
C64914
UMLS 2011AA Property-5
C1883720
NCI Thesaurus Property-6
C12417
UMLS 2011AA Property-6
C0041967
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
High-dose Radiation
Description

High-dose Radiation

Date of implant fraction #1
Description

BrachytherapyFirstFractionationImplantationDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15195
UMLS 2011AA ObjectClass
C0006098
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C15654
UMLS 2011AA Property-2
C0016640
NCI Thesaurus Property-3
C51982
UMLS 2011AA Property-3
C0021107
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Time of implant fraction #1
Description

BrachytherapyFirstFractionationImplantationTime

Data type

time

Alias
NCI Thesaurus ObjectClass
C15195
UMLS 2011AA ObjectClass
C0006098
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C15654
UMLS 2011AA Property-2
C0016640
NCI Thesaurus Property-3
C51982
UMLS 2011AA Property-3
C0021107
NCI Thesaurus ValueDomain
C25207
UMLS 2011AA ValueDomain
C0040223
Date of implant fraction #2
Description

BrachytherapySecondFractionationImplantationDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15195
UMLS 2011AA ObjectClass
C0006098
NCI Thesaurus Property
C25666
UMLS 2011AA Property
C0205436
NCI Thesaurus Property-2
C15654
UMLS 2011AA Property-2
C0016640
NCI Thesaurus Property-3
C51982
UMLS 2011AA Property-3
C0021107
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Time of implant fraction #2
Description

BrachytherapySecondFractionationImplantationTime

Data type

time

Alias
NCI Thesaurus ObjectClass
C15195
UMLS 2011AA ObjectClass
C0006098
NCI Thesaurus Property
C25666
UMLS 2011AA Property
C0205436
NCI Thesaurus Property-2
C15654
UMLS 2011AA Property-2
C0016640
NCI Thesaurus Property-3
C51982
UMLS 2011AA Property-3
C0021107
NCI Thesaurus ValueDomain
C25207
UMLS 2011AA ValueDomain
C0040223
Number of implant catheters used
Description

BrachytherapyCatheterImplantationUseCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C15195
UMLS 2011AA ObjectClass
C0006098
NCI Thesaurus Property
C17446
UMLS 2011AA Property
C0085590
NCI Thesaurus Property-2
C25340
UMLS 2011AA Property-2
C0457083
NCI Thesaurus Property-3
C51982
UMLS 2011AA Property-3
C0021107
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Total elapsed days (INCLUDING BOTH EXTERNAL RADIATION THERAPY AND BRACHYTHERAPY)
Description

RadiationTherapyTotalDayCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25304
UMLS 2011AA Property
C0439810
NCI Thesaurus Property-2
C25301
UMLS 2011AA Property-2
C0439228
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
Footer
Description

Footer

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Signature of Person Completing This Form
Description

Responsible Person Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25678
Date Form Originally Completed
Description

Form Completion Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS CUI-1
C1549507
NCI Thesaurus Property
C25250
NCI Thesaurus Property-2
C25604
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367

Similar models

Instructions: Form is submitted upon completion or termination of RT for all patients assigned RT. Dates are mmdd-yyyy unless specified otherwise. If assigned radiation and none given, complete Q#7, sign date and submit form.

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed Module 1
Protocol ID RTOG
Item
RTOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1514695 (UMLS CUI-2)
C19778 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
RadiationTherapyOncologyGroupPatientCaseIdentifierNumber
Item
Case #
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus ObjectClass-2)
C1514695 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49152 (NCI Thesaurus Property-2)
C1706256 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Institution Number
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Trial subject ID RTOG
Item
RTOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1514695 (UMLS CUI-2)
C19778 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Data amended
Item
Amended data
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Module 1
Radiation Therapy Start Date
Item
Radiation Therapy Start Date
date
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS CUI-1)
C25431 (NCI Thesaurus Property)
C0808070 (UMLS CUI-2)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Radiation Therapy End Date
Item
Radiation Therapy End Date
date
C25164 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
C25496 (NCI Thesaurus Property-2)
Total Number of Fractions
Item
RT Total Fraction Count
float
C25304 (NCI Thesaurus Property)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C1264633 (UMLS CUI-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS CUI-3)
C25514 (NCI Thesaurus Property-2)
Radiation Therapy Total Dose
Item
RT Total Dose (TO PTV)
float
C25304 (NCI Thesaurus ValueDomain)
C2169193 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C25488 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
RadiationTherapyTotalDayCount
Item
Total elapsed days (INCLUDING BOTH EXTERNAL RADIATION THERAPY AND BRACHYTHERAPY)
float
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25301 (NCI Thesaurus Property-2)
C0439228 (UMLS 2011AA Property-2)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
Item
Were there any unscheduled interruptions in radiation therapy? (EXCLUDING HOLIDAYS)
text
C25180 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C1512900 (UMLS CUI-2)
C25542 (NCI Thesaurus Property)
Code List
Were there any unscheduled interruptions in radiation therapy? (EXCLUDING HOLIDAYS)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Due To Toxicity (Yes, due to toxicity)
CL Item
Yes, Due To Other Reason (Yes, due to other reason)
Radiation Therapy Interruption Reason
Item
Specify RT interruption reason
text
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C3538832 (UMLS CUI-2)
C25211 (NCI Thesaurus Property-2)
C25542 (NCI Thesaurus Property-3)
C25685 (NCI Thesaurus ValueDomain)
Item
Reason Treatment Ended
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
Code List
Reason 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
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Death On Study (Death on study)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Off-treatmentAlternativeReasonSpecify
Item
Alternative Therapy, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25415 (NCI Thesaurus Property)
C1523987 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
Off Treatment Reason, specify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
C1521902 (UMLS CUI-3)
Item
Type of Radiation Therapy Administered
text
C25284 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0683312 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
Code List
Type of Radiation Therapy Administered
CL Item
3d Conformal + Imrt Boost (3D Conformal + IMRT Boost)
CL Item
Imrt (IMRT)
CL Item
Low-dose Treatment Brachytherapy 3-dimensional Conformal Radiation Therapy (3DCRT + Brachytherapy LDR)
C16035 (NCI Thesaurus)
C0600521 (UMLS 2011AA)
C15195 (NCI Thesaurus-3)
C0006098 (UMLS 2011AA-4)
C49341 (NCI Thesaurus-5)
C1708745 (UMLS 2011AA-6)
CL Item
Low-dose Treatment Brachytherapy Imrt (IMRT + Brachytherapy LDR)
C15195 (NCI Thesaurus)
C0006098 (UMLS 2011AA)
C16135 (NCI Thesaurus-3)
C1512814 (UMLS 2011AA-4)
C49341 (NCI Thesaurus-5)
C1708745 (UMLS 2011AA-6)
CL Item
High-dose Rate Brachytherapy 3-dimensional Conformal Radiation Therapy (3DCRT + Brachytherapy HDR)
C16035 (NCI Thesaurus)
C0600521 (UMLS 2011AA)
C15651 (NCI Thesaurus-3)
C0454270 (UMLS 2011AA-4)
CL Item
High-dose Rate Brachytherapy Imrt (IMRT + Brachytherapy HDR)
C16135 (NCI Thesaurus)
C1512814 (UMLS 2011AA)
C15651 (NCI Thesaurus-3)
C0454270 (UMLS 2011AA-4)
Item
What method of daily prostate localization was used
text
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
CL052062 (NCI Metathesaurus ObjectClass)
C28264 (NCI Thesaurus ObjectClass-2)
C0475264 (UMLS 2011AA ObjectClass-2)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
What method of daily prostate localization was used
CL Item
Cbct (CBCT)
CL Item
Helical Ct (Helical CT)
CL Item
Ct On Rails (CT on Rails)
CL Item
Portal Image/epid (Portal Image/EPID)
CL Item
Ultra Sound (Ultra sound)
CL Item
Optical Tracking (Optical Tracking)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
No Daily Localization Used (No Daily Localization Used)
DailyLocalizationProstateMethodSpecify
Item
Other, specify
text
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
CL052062 (NCI Metathesaurus ObjectClass)
C28264 (NCI Thesaurus ObjectClass-2)
C0475264 (UMLS 2011AA ObjectClass-2)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Brachytherapy
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)
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 Therapy Given (Alternative therapy given)
CL Item
Other Reason, Specify (Other reason, specify)
Alternative therapy, specify
Item
Specify therapy
text
C25685 (NCI Thesaurus ValueDomain)
C0949216 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25415 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
BrachytherapyOffTreatmentReasonSpecify
Item
Other reason, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
Item Group
Low-dose Radiation
BrachytherapyImplantDate
Item
Date of implant
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C17948 (NCI Thesaurus Property)
C0013183 (UMLS 2011AA Property)
CTPostBrachytherapyDate
Item
Date of post-implant CT
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)
Item
Seed loss (were seeds expelled within the 3 weeks of implant? If yes, report details in Comment 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)
Code List
Seed loss (were seeds expelled within the 3 weeks of implant? If yes, report details in Comment 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
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)
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)
SurgicalProcedureCatheterUrethraPostBrachytherapyPerformedDate
Item
Date inserted (Provide estimate if exact date unknown)
date
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)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
SurgicalProcedureCatheterUrethraPostBrachytherapyRemovePerformedDate
Item
Date removed (Provide estimate if exact date unknown)
date
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)
C64914 (NCI Thesaurus Property-5)
C1883720 (UMLS 2011AA Property-5)
C12417 (NCI Thesaurus Property-6)
C0041967 (UMLS 2011AA Property-6)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
High-dose Radiation
BrachytherapyFirstFractionationImplantationDate
Item
Date of implant fraction #1
date
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15654 (NCI Thesaurus Property-2)
C0016640 (UMLS 2011AA Property-2)
C51982 (NCI Thesaurus Property-3)
C0021107 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
BrachytherapyFirstFractionationImplantationTime
Item
Time of implant fraction #1
time
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15654 (NCI Thesaurus Property-2)
C0016640 (UMLS 2011AA Property-2)
C51982 (NCI Thesaurus Property-3)
C0021107 (UMLS 2011AA Property-3)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)
BrachytherapySecondFractionationImplantationDate
Item
Date of implant fraction #2
date
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C15654 (NCI Thesaurus Property-2)
C0016640 (UMLS 2011AA Property-2)
C51982 (NCI Thesaurus Property-3)
C0021107 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
BrachytherapySecondFractionationImplantationTime
Item
Time of implant fraction #2
time
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C15654 (NCI Thesaurus Property-2)
C0016640 (UMLS 2011AA Property-2)
C51982 (NCI Thesaurus Property-3)
C0021107 (UMLS 2011AA Property-3)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)
BrachytherapyCatheterImplantationUseCount
Item
Number of implant catheters used
float
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C17446 (NCI Thesaurus Property)
C0085590 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
C51982 (NCI Thesaurus Property-3)
C0021107 (UMLS 2011AA Property-3)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
RadiationTherapyTotalDayCount
Item
Total elapsed days (INCLUDING BOTH EXTERNAL RADIATION THERAPY AND BRACHYTHERAPY)
float
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25301 (NCI Thesaurus Property-2)
C0439228 (UMLS 2011AA Property-2)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
Item Group
Footer
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Responsible Person Signature
Item
Signature of Person Completing This Form
text
C25704 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C25678 (NCI Thesaurus Property)
Form Completion Date
Item
Date Form Originally Completed
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

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