ID

10070

Description

ELIGIBILITY CHECK Adjuvant Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer Prostate Cancer NCT00023829 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A570754B-7D62-2952-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A570754B-7D62-2952-E034-080020C9C0E0

Keywords

Versions (2)
  1. 9/19/12 9/19/12 -
  2. 3/23/15 3/23/15 - Martin Dugas
Uploaded on

March 23, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Prostate Cancer NCT00023829

English

(6/10/02)

1 forms  
  1. StudyEvent: ELIGIBILITY CHECK
    1. (6/10/02)
Header
Description

Header

Alias
UMLS CUI-1
C1320722
RTOG Institution #
Description

RTOGInstitution#

Data type

text

RTOG Case # (17.)
Description

RTOGCase#

Data type

text

Completed by
Description

CompletedBy

Data type

text

Date
Description

Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Eligibility Checklist
Description

Eligibility Checklist

Alias
UMLS CUI-1
C0013893
Does the patient have pathological stage T2-3N0M0 prostate cancer? (2. If the patient is T2)
Description

DoesthepatienthavepathologicalstageT2-3N0M0prostatecancer?

Data type

text

does the patient have Gleason score >= 7, pre-op PSA > 10, and positive surgical margins? (3. If the patient is T3)
Description

doesthepatienthaveGleasonscore>=7,pre-opPSA>10,andpositivesurgicalmargins?

Data type

text

is the Gleason score >= 7? (If yes)
Description

IstheGleasonscore>=7?

Data type

text

does patient have ONE or more of the following: a) Pre-op PSA > 10? b) Positive surgical margins? c) Seminal vesicle invasion? (If no)
Description

doespatienthaveONEormoreofthefollowing:a)Pre-opPSA>10?b)Positivesurgicalmargins?c)Seminalvesicleinvasion?

Data type

text

does patient have TWO or more of the following: a) Pre-op PSA > 10? b) Positive surgical margins? c) Seminal vesicle invasion? (4.)
Description

doespatienthaveTWOormoreofthefollowing:a)Pre-opPSA>10?b)Positivesurgicalmargins?c)Seminalvesicleinvasion?

Data type

text

Was the pre-op PS 40.0? (5.)
Description

Wasthepre-opPS40.0?

Data type

text

Is post-op PSA <= 0.2? (6.)
Description

Ispost-opPSA<=0.2?

Data type

boolean

Is Zubrod status 0-1? (7.)
Description

IsZubrodstatus0-1?

Data type

text

Are lymph nodes negative by lymph node sampling or lymph node dissection? (8.)
Description

Arelymphnodesnegativebylymphnodesamplingorlymphnodedissection?

Data type

boolean

Alias
UMLS CUI-1
C0678034
What is the WBC? (x 1000)
Description

WhatistheWBC?

Data type

text

What is the platelet count? (x 1000)
Description

Whatistheplateletcount?

Data type

text

What is the hgb? (>= 11.4)
Description

Whatisthehgb?

Data type

text

What is creatinine? ( 2.5)
Description

Whatiscreatinine?

Data type

text

What is ALT? (within 3 x normal)
Description

WhatisALT?

Data type

text

Will treatment begin within 6 weeks of randomization? (14.)
Description

Willtreatmentbeginwithin6weeksofrandomization?

Data type

boolean

If patient was receiving finasteride, has it been administered 60 days prior to this randomization? (15.)
Description

Ifpatientwasreceivingfinasteride,hasitbeenadministered60dayspriortothisrandomization?

Data type

boolean

If patient was receiving testosterone, has it been administered 90 days prior to this randomization? (16.)
Description

Ifpatientwasreceivingtestosterone,hasitbeenadministered90dayspriortothisrandomization?

Data type

boolean

Has any prior pharmacologic androgen ablation for prostate cancer been initiated greater than 10 months before randomization? (17.)
Description

Hasanypriorpharmacologicandrogenablationforprostatecancerbeeninitiatedgreaterthan10monthsbeforerandomization?

Data type

boolean

Any prior pelvic radiation therapy or orchiectomy? (18.)
Description

Anypriorpelvicradiationtherapyororchiectomy?

Data type

text

Any previous chemotherapy within the last 5 years?
Description

Anypreviouschemotherapywithinthelast5years?

Data type

boolean

Alias
UMLS CUI-1
C0392920
Have all mandatory lab studies been done? (20.)
Description

Haveallmandatorylabstudiesbeendone?

Data type

boolean

Any prior or concurrent malignancy other than non-melanoma skin cancer? (If yes)
Description

Anypriororconcurrentmalignancyotherthannon-melanomaskincancer?

Data type

text

disease free for 5 years? (1.)
Description

diseasefreefor5years?

Data type

text

Name of institutional person registering this case? (2.)
Description

Nameofinstitutionalpersonregisteringthiscase?

Data type

text

Has the Eligibility Checklist (above) been completed? (3.)
Description

HastheEligibilityChecklist(above)beencompleted?

Data type

text

Is the patient eligible for this study? (4.)
Description

Isthepatienteligibleforthisstudy?

Data type

text

Date the study-specific Consent Form was signed? (must be prior to study entry)
Description

Datethestudy-specificConsentFormwassigned?

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Patient's Name (6.)
Description

Patient'sName

Data type

text

Verifying Physician (7.)
Description

VerifyingPhysician

Data type

text

Patient's ID Number (8.)
Description

Patient'sIDNumber

Data type

text

Date of Birth (9.)
Description

DateofBirth

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Race (10.)
Description

Race

Data type

text

Social Security Number (11.)
Description

SocialSecurityNumber

Data type

text

Patient's Country of Residence (12.)
Description

Patient'sCountryofResidence

Data type

text

Zip Code (13.)
Description

ZipCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
Patient's Insurance Status (14.)
Description

Patient'sInsuranceStatus

Data type

text

Will any component of the patient's care be given at a military or VA facility? (15.)
Description

Willanycomponentofthepatient'scarebegivenatamilitaryorVAfacility?

Data type

boolean

Does the patient have seminal vesicle invasion? (16.)
Description

Doesthepatienthaveseminalvesicleinvasion?

Data type

text

Specify pre-operative PSA
Description

Specifypre-operativePSA

Data type

integer

Alias
UMLS CUI-1
C0138741
UMLS CUI-2
C0445204
Specify Gleason score (18.)
Description

SpecifyGleasonscore

Data type

float

Are there positive surgical (inked) margins? (19.)
Description

Aretherepositivesurgical(inked)margins?

Data type

text

Did patient receive neoadjuvant hormonal therapy? (20.)
Description

Didpatientreceiveneoadjuvanthormonaltherapy?

Data type

text

Is the patient going to receive IMRT? (20.)
Description

IsthepatientgoingtoreceiveIMRT?

Data type

text

Treatment Start Date (21.)
Description

TreatmentStartDate

Data type

date

Treatment Assignment
Description

TreatmentAssignment

Data type

text

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Similar models

(6/10/02)

1 forms
  1. StudyEvent: ELIGIBILITY CHECK
    1. (6/10/02)
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
RTOGInstitution#
Item
RTOG Institution #
text
RTOGCase#
Item
RTOG Case # (17.)
text
CompletedBy
Item
Completed by
text
Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Eligibility Checklist
C0013893 (UMLS CUI-1)
Item
Does the patient have pathological stage T2-3N0M0 prostate cancer? (2. If the patient is T2)
text
CL.1
Code List
Does the patient have pathological stage T2-3N0M0 prostate cancer? (2. If the patient is T2)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
does the patient have Gleason score >= 7, pre-op PSA > 10, and positive surgical margins? (3. If the patient is T3)
text
CL.2
Code List
does the patient have Gleason score >= 7, pre-op PSA > 10, and positive surgical margins? (3. If the patient is T3)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
is the Gleason score >= 7? (If yes)
text
CL.3
Code List
is the Gleason score >= 7? (If yes)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (N)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
does patient have ONE or more of the following: a) Pre-op PSA > 10? b) Positive surgical margins? c) Seminal vesicle invasion? (If no)
text
CL.4
Code List
does patient have ONE or more of the following: a) Pre-op PSA > 10? b) Positive surgical margins? c) Seminal vesicle invasion? (If no)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Not Applicable (NA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
does patient have TWO or more of the following: a) Pre-op PSA > 10? b) Positive surgical margins? c) Seminal vesicle invasion? (4.)
text
CL.5
Code List
does patient have TWO or more of the following: a) Pre-op PSA > 10? b) Positive surgical margins? c) Seminal vesicle invasion? (4.)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Not Applicable (NA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
Was the pre-op PS 40.0? (5.)
text
CL.6
Code List
Was the pre-op PS 40.0? (5.)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PSA below 0.2 postoperative
Item
Is post-op PSA <= 0.2? (6.)
boolean
Item
Is Zubrod status 0-1? (7.)
text
CL.8
Code List
Is Zubrod status 0-1? (7.)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Lymph nodes negative
Item
Are lymph nodes negative by lymph node sampling or lymph node dissection? (8.)
boolean
C0678034 (UMLS CUI-1)
WhatistheWBC?
Item
What is the WBC? (x 1000)
text
Whatistheplateletcount?
Item
What is the platelet count? (x 1000)
text
Whatisthehgb?
Item
What is the hgb? (>= 11.4)
text
Whatiscreatinine?
Item
What is creatinine? ( 2.5)
text
WhatisALT?
Item
What is ALT? (within 3 x normal)
text
Treatment begin within 6 weeks of randomization
Item
Will treatment begin within 6 weeks of randomization? (14.)
boolean
Finasteride 60 days before randomization
Item
If patient was receiving finasteride, has it been administered 60 days prior to this randomization? (15.)
boolean
Testosteron 90 days before randomization
Item
If patient was receiving testosterone, has it been administered 90 days prior to this randomization? (16.)
boolean
prior androgen ablation
Item
Has any prior pharmacologic androgen ablation for prostate cancer been initiated greater than 10 months before randomization? (17.)
boolean
Item
Any prior pelvic radiation therapy or orchiectomy? (18.)
text
CL.14
Code List
Any prior pelvic radiation therapy or orchiectomy? (18.)
CL Item
No (N)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Chemotherapy past 5 years
Item
Any previous chemotherapy within the last 5 years?
boolean
C0392920 (UMLS CUI-1)
Mandatory lab studies done
Item
Have all mandatory lab studies been done? (20.)
boolean
Item
Any prior or concurrent malignancy other than non-melanoma skin cancer? (If yes)
text
CL.17
Code List
Any prior or concurrent malignancy other than non-melanoma skin cancer? (If yes)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (N)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
disease free for 5 years? (1.)
text
CL.18
Code List
disease free for 5 years? (1.)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Nameofinstitutionalpersonregisteringthiscase?
Item
Name of institutional person registering this case? (2.)
text
Item
Has the Eligibility Checklist (above) been completed? (3.)
text
CL.19
Code List
Has the Eligibility Checklist (above) been completed? (3.)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Is the patient eligible for this study? (4.)
text
CL.20
Code List
Is the patient eligible for this study? (4.)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Datethestudy-specificConsentFormwassigned?
Item
Date the study-specific Consent Form was signed? (must be prior to study entry)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Patient'sName
Item
Patient's Name (6.)
text
VerifyingPhysician
Item
Verifying Physician (7.)
text
Patient'sIDNumber
Item
Patient's ID Number (8.)
text
DateofBirth
Item
Date of Birth (9.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Race
Item
Race (10.)
text
SocialSecurityNumber
Item
Social Security Number (11.)
text
Patient'sCountryofResidence
Item
Patient's Country of Residence (12.)
text
ZipCode
Item
Zip Code (13.)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
Patient'sInsuranceStatus
Item
Patient's Insurance Status (14.)
text
care at military facility
Item
Will any component of the patient's care be given at a military or VA facility? (15.)
boolean
Item
Does the patient have seminal vesicle invasion? (16.)
text
CL.21
Code List
Does the patient have seminal vesicle invasion? (16.)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (N)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Specify pre-operative PSA
integer
C0138741 (UMLS CUI-1)
C0445204 (UMLS CUI-2)
CL.22
Code List
Specify pre-operative PSA
CL Item
below 10 (1)
CL Item
above 10 (2)
SpecifyGleasonscore
Item
Specify Gleason score (18.)
float
Item
Are there positive surgical (inked) margins? (19.)
text
CL.24
Code List
Are there positive surgical (inked) margins? (19.)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (N)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Did patient receive neoadjuvant hormonal therapy? (20.)
text
CL.25
Code List
Did patient receive neoadjuvant hormonal therapy? (20.)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (N)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the patient going to receive IMRT? (20.)
text
CL.26
Code List
Is the patient going to receive IMRT? (20.)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (N)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
TreatmentStartDate
Item
Treatment Start Date (21.)
date
TreatmentAssignment
Item
Treatment Assignment
text
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