ID

10070

Descrizione

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

collegamento

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

Keywords

versioni (2)
  1. 19/09/12 19/09/12 -
  2. 23/03/15 23/03/15 - Martin Dugas
Caricato su

23 marzo 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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Prostate Cancer NCT00023829

Inglese

(6/10/02)

1 moduli  
  1. StudyEvent: ELIGIBILITY CHECK
    1. (6/10/02)
Header
Descrizione

Header

Alias
UMLS CUI-1
C1320722
RTOG Institution #
Descrizione

RTOGInstitution#

Tipo di dati

text

RTOG Case # (17.)
Descrizione

RTOGCase#

Tipo di dati

text

Completed by
Descrizione

CompletedBy

Tipo di dati

text

Date
Descrizione

Date

Tipo di dati

date

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

Eligibility Checklist

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

DoesthepatienthavepathologicalstageT2-3N0M0prostatecancer?

Tipo di dati

text

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

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

Tipo di dati

text

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

IstheGleasonscore>=7?

Tipo di dati

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)
Descrizione

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

Tipo di dati

text

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

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

Tipo di dati

text

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

Wasthepre-opPS40.0?

Tipo di dati

text

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

Ispost-opPSA<=0.2?

Tipo di dati

boolean

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

IsZubrodstatus0-1?

Tipo di dati

text

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

Arelymphnodesnegativebylymphnodesamplingorlymphnodedissection?

Tipo di dati

boolean

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

WhatistheWBC?

Tipo di dati

text

What is the platelet count? (x 1000)
Descrizione

Whatistheplateletcount?

Tipo di dati

text

What is the hgb? (>= 11.4)
Descrizione

Whatisthehgb?

Tipo di dati

text

What is creatinine? ( 2.5)
Descrizione

Whatiscreatinine?

Tipo di dati

text

What is ALT? (within 3 x normal)
Descrizione

WhatisALT?

Tipo di dati

text

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

Willtreatmentbeginwithin6weeksofrandomization?

Tipo di dati

boolean

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

Ifpatientwasreceivingfinasteride,hasitbeenadministered60dayspriortothisrandomization?

Tipo di dati

boolean

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

Ifpatientwasreceivingtestosterone,hasitbeenadministered90dayspriortothisrandomization?

Tipo di dati

boolean

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

Hasanypriorpharmacologicandrogenablationforprostatecancerbeeninitiatedgreaterthan10monthsbeforerandomization?

Tipo di dati

boolean

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

Anypriorpelvicradiationtherapyororchiectomy?

Tipo di dati

text

Any previous chemotherapy within the last 5 years?
Descrizione

Anypreviouschemotherapywithinthelast5years?

Tipo di dati

boolean

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

Haveallmandatorylabstudiesbeendone?

Tipo di dati

boolean

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

Anypriororconcurrentmalignancyotherthannon-melanomaskincancer?

Tipo di dati

text

disease free for 5 years? (1.)
Descrizione

diseasefreefor5years?

Tipo di dati

text

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

Nameofinstitutionalpersonregisteringthiscase?

Tipo di dati

text

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

HastheEligibilityChecklist(above)beencompleted?

Tipo di dati

text

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

Isthepatienteligibleforthisstudy?

Tipo di dati

text

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

Datethestudy-specificConsentFormwassigned?

Tipo di dati

date

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

Patient'sName

Tipo di dati

text

Verifying Physician (7.)
Descrizione

VerifyingPhysician

Tipo di dati

text

Patient's ID Number (8.)
Descrizione

Patient'sIDNumber

Tipo di dati

text

Date of Birth (9.)
Descrizione

DateofBirth

Tipo di dati

date

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

Race

Tipo di dati

text

Social Security Number (11.)
Descrizione

SocialSecurityNumber

Tipo di dati

text

Patient's Country of Residence (12.)
Descrizione

Patient'sCountryofResidence

Tipo di dati

text

Zip Code (13.)
Descrizione

ZipCode

Tipo di dati

text

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

Patient'sInsuranceStatus

Tipo di dati

text

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

Willanycomponentofthepatient'scarebegivenatamilitaryorVAfacility?

Tipo di dati

boolean

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

Doesthepatienthaveseminalvesicleinvasion?

Tipo di dati

text

Specify pre-operative PSA
Descrizione

Specifypre-operativePSA

Tipo di dati

integer

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

SpecifyGleasonscore

Tipo di dati

float

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

Aretherepositivesurgical(inked)margins?

Tipo di dati

text

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

Didpatientreceiveneoadjuvanthormonaltherapy?

Tipo di dati

text

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

IsthepatientgoingtoreceiveIMRT?

Tipo di dati

text

Treatment Start Date (21.)
Descrizione

TreatmentStartDate

Tipo di dati

date

Treatment Assignment
Descrizione

TreatmentAssignment

Tipo di dati

text

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Similar models

(6/10/02)

1 moduli
  1. StudyEvent: ELIGIBILITY CHECK
    1. (6/10/02)
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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