ID

8160

Description

RTOG-0521 T1: Radiation Therapy Oncology Group Phase III Randomized Study of Localized, High-Risk Prostate Cancer Radiotherapy Form Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F6709418-1311-5298-E034-0003BA3F9857

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F6709418-1311-5298-E034-0003BA3F9857

Mots-clés

Versions (3)
  1. 19/09/2012 19/09/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 21/06/2015 21/06/2015 -
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9 janvier 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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NCT00288080 Treatment - RTOG-0521 T1: Radiation Therapy Oncology Group Phase III Randomized Study of Localized, High-Risk Prostate Cancer Radiotherapy Form - 2224903v1.0

Anglais

No Instruction available.

1 Formulaires  
  1. StudyEvent: RTOG-0521 T1: Radiation Therapy Oncology Group Phase III Randomized Study of Localized, High-Risk Prostate Cancer Radiotherapy Form
    1. No Instruction available.
Unnamed Module 1
Description

Unnamed Module 1

RTOG Study No.
Description

Protocol ID RTOG

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Unamed Module 2
Description

Unamed Module 2

RADIATION THERAPY START DATE
Description

Radiation Therapy Start Date

Type de données

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

Type de données

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
ELAPSED DAYS
Description

RadiationTherapyTotalDayCount

Type de données

float

Alias
NCI Thesaurus Property
C25304
UMLS 2011AA Property
C0439810
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
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
RT Total Fraction Count
Description

Total Number of Fractions

Type de données

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
Description

Radiation Therapy Total Dose

Type de données

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2169193
NCI Thesaurus ObjectClass
C15313
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus Property
C25382
Were there any unscheduled interruptions in radiation therapy?
Description

Unscheduled Interruptions in Radiation Therapy

Type de données

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

Type de données

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

Type de données

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

Alternative therapy, specify

Type de données

text

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

Off-TreatmentConditionSpecify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25457
UMLS 2011AA Property
C0348080
Other, specify
Description

Off-TreatmentOtherReasonSpecify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
New or continuing adverse events (*IF PATIENT EXPERIENCED ANY TREATMENT RELATED ADVERSE EVENTS DURING THIS REPORT PERIOD, SUBMIT ADVERSE EVENT FORM AE)
Description

Adverse Event

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0877248
NCI Thesaurus ObjectClass
C25586
NCI Thesaurus ObjectClass-2
C41331
NCI Thesaurus Property
C25275
Type of Radiation Therapy Administered
Description

Radiation Therapy Type

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1522449
NCI Thesaurus ObjectClass
C15313
UMLS CUI-2
C0683312
NCI Thesaurus Property
C25382
Comments
Description

Comments

Comments
Description

Research Comments

Type de données

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

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25678
Form Completion Date, Original
Description

Form Completion Date

Type de données

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
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Similar models

No Instruction available.

1 Formulaires
  1. StudyEvent: RTOG-0521 T1: Radiation Therapy Oncology Group Phase III Randomized Study of Localized, High-Risk Prostate Cancer Radiotherapy Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
Unamed Module 2
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)
RadiationTherapyTotalDayCount
Item
ELAPSED DAYS
float
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
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)
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
float
C25304 (NCI Thesaurus ValueDomain)
C2169193 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C25488 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Item
Were there any unscheduled interruptions in radiation therapy?
text
C25180 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C1512900 (UMLS CUI-2)
C25542 (NCI Thesaurus Property)
CL.2
Code List
Were there any unscheduled interruptions in radiation therapy?
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)
CL.3
Code List
Reason Treatment Ended
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Alternative therapy, specify
Item
Alternative therapy, specify
text
C25685 (NCI Thesaurus ValueDomain)
C0949216 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25415 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
Off-TreatmentConditionSpecify
Item
Other complicating disease, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)
Off-TreatmentOtherReasonSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
Adverse Event
Item
New or continuing adverse events (*IF PATIENT EXPERIENCED ANY TREATMENT RELATED ADVERSE EVENTS DURING THIS REPORT PERIOD, SUBMIT ADVERSE EVENT FORM AE)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0877248 (UMLS CUI-1)
C25586 (NCI Thesaurus ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C25275 (NCI Thesaurus Property)
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)
CL.5
Code List
Type of Radiation Therapy Administered
CL Item
3d Conformal (3D conformal)
CL Item
Imrt (IMRT)
Item Group
Comments
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
Form Completion Date, Original
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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