ID

11074

Description

PACCT-1 TAILORx Chemotherapy Form NCT00310180 Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=05DD92D7-B59A-692F-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=05DD92D7-B59A-692F-E044-0003BA3F9857

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/18/15 6/18/15 -
Uploaded on

June 18, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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PACCT-1 TAILORx Chemotherapy Form NCT00310180

English

No Instruction available.

1 forms  
  1. StudyEvent: PACCT-1 TAILORx Chemotherapy Form
    1. No Instruction available.
Header
Description

Header

ECOG Protocol Number
Description

Protocol Number ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Description

Patient ID ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
DCI Name
Description

Generic drug form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step Number
Description

Registration Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Reporting Period
Description

Clinical Trial Period

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Assessment of Chemotherapy
Description

Assessment of Chemotherapy

Chemotherapy Regimen (see protocol Appendix II for schedules; if drugs were substituted or omitted during treatment because of toxicity, indicate the initial planned regimen)
Description

ChemotherapyRegimenType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
specify study number and treatment arm (given as part of a CTSU adjuvant therapy protocol)
Description

AdjuvantChemotherapyRegimenSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
specify drugs and schedule (other chemotherapy regimen)
Description

ChemotherapyRegimenSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
Date Chemotherapy Began (date 1st cycle given m/d/y)
Description

Chemotherapy Start Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1302181
NCI Thesaurus ObjectClass
C15632
UMLS CUI-2
C3173309
NCI Thesaurus ValueDomain-2
C25431
NCI Thesaurus Property
C25382
Date Chemotherapy Ended (date last cycle given m/d/y)
Description

ChemotherapyAdministeredEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Taxane Use
Description

TaxaneCompoundAgentAdministeredType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ObjectClass-2
C1490
UMLS 2011AA ObjectClass-2
C0796419
Total number of chemotherapy cycles completed
Description

ChemotherapyTotalCycleCompleteCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property-2
C25304
UMLS 2011AA Property-2
C0439810
NCI Thesaurus Property-3
C25472
UMLS 2011AA Property-3
C1511572
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Footer Module
Description

Footer Module

Investigator Signature
Description

Investigator Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date
Description

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: PACCT-1 TAILORx Chemotherapy Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step Number
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Item
Reporting Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
CL.1
Code List
Reporting Period
CL Item
Completion Of Chemotherapy (Completion of chemotherapy)
Item Group
Assessment of Chemotherapy
Item
Chemotherapy Regimen (see protocol Appendix II for schedules; if drugs were substituted or omitted during treatment because of toxicity, indicate the initial planned regimen)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
CL.2
Code List
Chemotherapy Regimen (see protocol Appendix II for schedules; if drugs were substituted or omitted during treatment because of toxicity, indicate the initial planned regimen)
CL Item
Oral Cyclophosphamide, Methotrexate And 5-fluorouracil (cmf) (Oral CMF)
CL Item
Intravenous Cyclophosphamide, Methotrexate, And Fluorouracil (cmf) (IV CMF)
CL Item
Standard Anthracycline And Cyclophosphamide (ac) Therapy (standard AC)
CL Item
Dose Dense Anthracycline (doxorubicin) And Cyclophosphamide (ac) Therapy (dose dense AC)
CL Item
Standard Anthracycline (doxorubicin) And Cyclophosphamide (ac) Followed By A Taxane (standard AC followed by a taxane)
CL Item
Dose Dense Anthracycline (doxorubicin) And Cyclophosphamide (ac) Followed By A Taxane (dose dense AC followed by a taxane)
CL Item
5-fluorouracil, Epirubicin, Cyclophosphamide (fec) (FEC)
CL Item
Doxorubicin, Cyclophosphamide, And Docetaxel (tac) (TAC)
CL Item
Docetaxel And Cyclophosphamide (tc) Therapy (TC)
CL Item
Other Regimen Given As Part Of A Ctsu Adjuvant Therapy Protocol (other regimen given as part of a CTSU adjuvant therapy protocol)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Not Given (Chemotherapy not given)
AdjuvantChemotherapyRegimenSpecify
Item
specify study number and treatment arm (given as part of a CTSU adjuvant therapy protocol)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
ChemotherapyRegimenSpecify
Item
specify drugs and schedule (other chemotherapy regimen)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
Chemotherapy Start Date
Item
Date Chemotherapy Began (date 1st cycle given m/d/y)
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15632 (NCI Thesaurus ObjectClass)
C3173309 (UMLS CUI-2)
C25431 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
ChemotherapyAdministeredEndDate
Item
Date Chemotherapy Ended (date last cycle given m/d/y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Taxane Use
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C1490 (NCI Thesaurus ObjectClass-2)
C0796419 (UMLS 2011AA ObjectClass-2)
CL.3
Code List
Taxane Use
CL Item
None: C41132 (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Paclitaxel (Paclitaxel)
C1411 (NCI Thesaurus)
C0144576 (UMLS 2011AA)
CL Item
Docetaxel (Docetaxel)
C1526 (NCI Thesaurus)
C0246415 (UMLS 2011AA)
ChemotherapyTotalCycleCompleteCount
Item
Total number of chemotherapy cycles completed
float
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25304 (NCI Thesaurus Property-2)
C0439810 (UMLS 2011AA Property-2)
C25472 (NCI Thesaurus Property-3)
C1511572 (UMLS 2011AA Property-3)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item Group
Footer Module
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
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