ID

10552

Beschreibung

NCT00023829 FF Radiation Therapy Oncology Group Phase III Randomized Study of Adjuvant Therapy for High Risk pT3NO Prostate Cancer Long Term Follow-up Form Adjuvant Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A56DBAD2-8C43-0FEF-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A56DBAD2-8C43-0FEF-E034-080020C9C0E0

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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Lizenz

Creative Commons BY-NC 3.0 Legacy
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NCT00023829 FF Radiation Therapy Oncology Group Phase III Randomized Study of Adjuvant Therapy for High Risk pT3NO Prostate Cancer Long Term Follow-up Form

Englisch

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. This form may be used after 5 years provided none of the following events have occurred since the last submitted report: change in disease status; new or continuing toxicity; new therapy for cancer, the patient expired. If any of these events have occurred, submit the standard F1 form.

1 Formulare  
RTOG clinical trial administrative data
Beschreibung

RTOG clinical trial administrative data

RTOG Study
Beschreibung

RTOGStudy

Datentyp

text

Case #
Beschreibung

Case#

Datentyp

text

Institution
Beschreibung

Institution

Datentyp

text

Institution No.
Beschreibung

InstitutionNo.

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Patient Name, Last
Beschreibung

PatientName,Last

Datentyp

text

Patient Name, First (1)
Beschreibung

PatientName,First

Datentyp

text

Amended Data
Beschreibung

AmendedData

Datentyp

text

Medical history
Beschreibung

Medical history

PATIENT'S VITAL STATUS (2)
Beschreibung

Patient'sVitalStatus

Datentyp

text

DATE OF LAST CONTACT OR DEATH (3)
Beschreibung

DeathDate/LastContactDate

Datentyp

date

CAUSE OF DEATH (IF DEAD)
Beschreibung

Causeofdeath

Datentyp

text

Due to other cause, specify (cause of death) (4)
Beschreibung

PrimaryCauseDeathOtherReasonSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Metathesaurus ObjectClass
C0007465
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
HAS THE PATIENT HAD A DOCUMENTED CLINICAL ASSESSMENT FOR PROSTATE CANCER SINCE SUBMISSION OF THE PREVIOUS FOLLOWUP FORM?
Beschreibung

HASTHEPATIENTHADADOCUMENTEDCLINICALASSESSMENTFORPROSTATECANCERSINCESUBMISSIONOFTHEPREVIOUSFOLLOWUPFORM?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C25180
UMLS 2011AA ValueDomain-2
C1522602
DATE OF LAST CLINICAL ASSESSMENT (5 PROSTATE: PSA MEASUREMENTS)
Beschreibung

CancerFollow-upStatusDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Follow-up PSA Value(s)
Beschreibung

Follow-upPSAValue(s)

Datentyp

text

Date of PSA Assessment(s) (6)
Beschreibung

DateofPSAAssessment(s)

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
HAS CLINICAL DISEASE STATUS local, regional, distant CHANGED SINCE THE LAST REPORT? (7 HAS A NEW PRIMARY CANCER OR MDS MYELODYSPLASTIC SYNDROME BEEN DIAGNOSED THAT HAS NOT BEEN PREVIOUSLY REPORTED?)
Beschreibung

HASCLINICALDISEASESTATUSlocal,regional,distantCHANGEDSINCETHELASTREPORT?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
New Primary Site
Beschreibung

NewCancerDiagnosisAnatomicSite

Datentyp

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 (Specify in comments new primary site)
Beschreibung

NewPrimaryCancerDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
RENAL/GENITOURINARY TOXICITY ADVERSE EVENT REPORTS (AER) (Use CTC 2.0 to code severity)
Beschreibung

RENAL/GENITOURINARYTOXICITYADVERSEEVENTREPORTS(AER)

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C25180
UMLS 2011AA ValueDomain-2
C1522602
URINARY INCONTINENCE, Severity Grade (0-3)
Beschreibung

URINARYINCONTINENCE,SeverityGrade

Datentyp

text

URINARY INCONTINENCE, Attribution (see table below)
Beschreibung

URINARYINCONTINENCE,Attribution

Datentyp

text

Specify if other cause (urinary incontinence, attribution)
Beschreibung

Specifyifothercause(urinaryincontinence,attribution)

Datentyp

text

URINARY INCONTINENCE, AER Begin Date
Beschreibung

URINARYINCONTINENCE,AERBeginDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
URINARY FREQUENCY/URGENCY, Severity Grade (0-3)
Beschreibung

URINARYFREQUENCY/URGENCY,SeverityGrade

Datentyp

text

URINARY FREQUENCY/URGENCY, Attribution (see table below)
Beschreibung

URINARYFREQUENCY/URGENCY,Attribution

Datentyp

text

Specify if other cause (urinary frequency/urgency, attribution)
Beschreibung

Specifyifothercause(urinaryfrequency/urgency,attribution)

Datentyp

text

URINARY FREQUENCY/URGENCY, AER Begin Date
Beschreibung

URINARYFREQUENCY/URGENCY,AERBeginDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
ERECTILE IMPOTENCE, Severity Grade (0-3)
Beschreibung

ERECTILEIMPOTENCE,SeverityGrade

Datentyp

text

ERECTILE IMPOTENCE, Attribution (see table below)
Beschreibung

ERECTILEIMPOTENCE,Attribution

Datentyp

text

Specify if other cause (erectile impotence, attribution)
Beschreibung

Specifyifothercause(erectileimpotence,attribution)

Datentyp

text

ERECTILE IMPOTENCE, AER Begin Date (9)
Beschreibung

ERECTILEIMPOTENCE,AERBeginDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NEW OR CONTINUING TOXICITY (>= Severity Grade 3) SINCE THE LAST REPORT? (10)
Beschreibung

NEWORCONTINUINGTOXICITY(>=SeverityGrade3)SINCETHELASTREPORT?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C25180
UMLS 2011AA ValueDomain-2
C1522602
DID THE PATIENT RECEIVE ANY NON-PROTOCOL PROSTATE CANCER THERAPY SINCE THE LAST FOLLOW-UP?
Beschreibung

DIDTHEPATIENTRECEIVEANYNON-PROTOCOLPROSTATECANCERTHERAPYSINCETHELASTFOLLOW-UP?

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C25180
UMLS 2011AA ValueDomain-2
C1522602
COMMENTS
Beschreibung

Comments

Datentyp

text

SIGNATURE
Beschreibung

Signature

Datentyp

text

DATE
Beschreibung

Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Ccrr Module For Ff Radiation Therapy Oncology Group Phase Iii Randomized Study Of Adjuvant Therapy For High Risk Pt3no Prostate Cancer Long Term Follow-up Form
Beschreibung

Ccrr Module For Ff Radiation Therapy Oncology Group Phase Iii Randomized Study Of Adjuvant Therapy For High Risk Pt3no Prostate Cancer Long Term Follow-up Form

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Ähnliche Modelle

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. This form may be used after 5 years provided none of the following events have occurred since the last submitted report: change in disease status; new or continuing toxicity; new therapy for cancer, the patient expired. If any of these events have occurred, submit the standard F1 form.

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
RTOG clinical trial administrative data
RTOGStudy
Item
RTOG Study
text
Case#
Item
Case #
text
Institution
Item
Institution
text
InstitutionNo.
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
PatientName,Last
Item
Patient Name, Last
text
PatientName,First
Item
Patient Name, First (1)
text
AmendedData
Item
Amended Data
text
Item Group
Medical history
Item
PATIENT'S VITAL STATUS (2)
text
CL.1
Code List
PATIENT'S VITAL STATUS (2)
CL Item
Alive (Alive)
CL Item
Dead (Dead)
CL Item
Unknown or not applicable (Unknown or not applicable)
DeathDate/LastContactDate
Item
DATE OF LAST CONTACT OR DEATH (3)
date
Item
CAUSE OF DEATH (IF DEAD)
text
CL.2
Code List
CAUSE OF DEATH (IF DEAD)
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, specify (Due to other cause, specify)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PrimaryCauseDeathOtherReasonSpecify
Item
Due to other cause, specify (cause of death) (4)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C0007465 (NCI Metathesaurus ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
HAS THE PATIENT HAD A DOCUMENTED CLINICAL ASSESSMENT FOR PROSTATE CANCER SINCE SUBMISSION OF THE PREVIOUS FOLLOWUP FORM?
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C1522602 (UMLS 2011AA ValueDomain-2)
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 (5 PROSTATE: PSA MEASUREMENTS)
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Follow-upPSAValue(s)
Item
Follow-up PSA Value(s)
text
DateofPSAAssessment(s)
Item
Date of PSA Assessment(s) (6)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
HAS CLINICAL DISEASE STATUS local, regional, distant CHANGED SINCE THE LAST REPORT? (7 HAS A NEW PRIMARY CANCER OR MDS MYELODYSPLASTIC SYNDROME BEEN DIAGNOSED THAT HAS NOT BEEN PREVIOUSLY REPORTED?)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.4
Code List
HAS CLINICAL DISEASE STATUS local, regional, distant CHANGED SINCE THE LAST REPORT? (7 HAS A NEW PRIMARY CANCER OR MDS MYELODYSPLASTIC SYNDROME 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)
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)
CL.5
Code List
New Primary Site
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Aml/mds (AML/MDS)
C9441 (NCI Thesaurus)
CL Item
Bcc (BCC)
CL Item
Bladder (Bladder)
C12414 (NCI Thesaurus)
C0005682 (UMLS 2011AA)
CL Item
Brain (Brain)
C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)
CL Item
Colorectal (Colorectal)
C13363 (NCI Thesaurus)
C0555952 (UMLS 2011AA)
CL Item
Esophageal (Esophageal)
C37950 (NCI Thesaurus)
C1522619 (UMLS 2011AA)
CL Item
Gastric (Gastric)
C13307 (NCI Thesaurus)
C1704242 (UMLS 2011AA)
CL Item
Liver (Liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Lung (Lung)
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Melanoma (Melanoma)
C3224 (NCI Thesaurus)
C0025202 (UMLS 2011AA)
CL Item
Nhl (NHL)
CL Item
Pancreatic (Pancreatic)
C25726 (NCI Thesaurus)
C0030274 (UMLS 2011AA)
CL Item
Renal (Renal)
C25225 (NCI Thesaurus)
C0022646 (UMLS 2011AA)
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)
NewPrimaryCancerDate
Item
New Primary Cancer Date (Specify in comments new primary site)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
RENAL/GENITOURINARY TOXICITY ADVERSE EVENT REPORTS (AER) (Use CTC 2.0 to code severity)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C1522602 (UMLS 2011AA ValueDomain-2)
CL.6
Code List
RENAL/GENITOURINARY TOXICITY ADVERSE EVENT REPORTS (AER) (Use CTC 2.0 to code severity)
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
URINARY INCONTINENCE, Severity Grade (0-3)
text
CL.7
Code List
URINARY INCONTINENCE, Severity Grade (0-3)
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
Item
URINARY INCONTINENCE, Attribution (see table below)
text
CL.8
Code List
URINARY INCONTINENCE, Attribution (see table below)
CL Item
Radiotherapy only (Radiotherapy only)
CL Item
Combined modality (Hormone, RT) (Combined modality (Hormone, RT))
CL Item
Tumor and Rx (Tumor and Rx)
CL Item
Hormones (Hormones)
CL Item
Other cause, specify (Other cause, specify)
CL Item
Unknown (Unknown)
Specifyifothercause(urinaryincontinence,attribution)
Item
Specify if other cause (urinary incontinence, attribution)
text
URINARYINCONTINENCE,AERBeginDate
Item
URINARY INCONTINENCE, AER Begin Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
URINARY FREQUENCY/URGENCY, Severity Grade (0-3)
text
CL.9
Code List
URINARY FREQUENCY/URGENCY, Severity Grade (0-3)
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
Item
URINARY FREQUENCY/URGENCY, Attribution (see table below)
text
CL.10
Code List
URINARY FREQUENCY/URGENCY, Attribution (see table below)
CL Item
Radiotherapy only (Radiotherapy only)
CL Item
Combined modality (Hormone, RT) (Combined modality (Hormone, RT))
CL Item
Tumor and Rx (Tumor and Rx)
CL Item
Hormones (Hormones)
CL Item
Other cause, specify (Other cause, specify)
CL Item
Unknown (Unknown)
Specifyifothercause(urinaryfrequency/urgency,attribution)
Item
Specify if other cause (urinary frequency/urgency, attribution)
text
URINARYFREQUENCY/URGENCY,AERBeginDate
Item
URINARY FREQUENCY/URGENCY, AER Begin Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
ERECTILE IMPOTENCE, Severity Grade (0-3)
text
CL.11
Code List
ERECTILE IMPOTENCE, Severity Grade (0-3)
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
Item
ERECTILE IMPOTENCE, Attribution (see table below)
text
CL.12
Code List
ERECTILE IMPOTENCE, Attribution (see table below)
CL Item
Radiotherapy only (Radiotherapy only)
CL Item
Combined modality (Hormone, RT) (Combined modality (Hormone, RT))
CL Item
Tumor and Rx (Tumor and Rx)
CL Item
Hormones (Hormones)
CL Item
Other cause, specify (Other cause, specify)
CL Item
Unknown (Unknown)
Specifyifothercause(erectileimpotence,attribution)
Item
Specify if other cause (erectile impotence, attribution)
text
ERECTILEIMPOTENCE,AERBeginDate
Item
ERECTILE IMPOTENCE, AER Begin Date (9)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
NEW OR CONTINUING TOXICITY (>= Severity Grade 3) SINCE THE LAST REPORT? (10)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C1522602 (UMLS 2011AA ValueDomain-2)
CL.13
Code List
NEW OR CONTINUING TOXICITY (>= Severity Grade 3) SINCE THE LAST REPORT? (10)
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
DID THE PATIENT RECEIVE ANY NON-PROTOCOL PROSTATE CANCER THERAPY SINCE THE LAST FOLLOW-UP?
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C1522602 (UMLS 2011AA ValueDomain-2)
CL.14
Code List
DID THE PATIENT RECEIVE ANY NON-PROTOCOL PROSTATE CANCER THERAPY SINCE THE LAST FOLLOW-UP?
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)
Comments
Item
COMMENTS
text
Signature
Item
SIGNATURE
text
Date
Item
DATE
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Ccrr Module For Ff Radiation Therapy Oncology Group Phase Iii Randomized Study Of Adjuvant Therapy For High Risk Pt3no Prostate Cancer Long Term Follow-up Form
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