ID

11739

Description

Treatment Chemotherapy-docetaxel/capecitabine arm Breast Cancer NCT00433589 Breast Cancer NCT00433589 Treatment - Chemotherapy-docetaxel/capecitabine arm - 2499349v1.0 Chemotherapy-docetaxel/capecitabine arm Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes NCT00433589 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=196E5474-4AF3-680E-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=196E5474-4AF3-680E-E044-0003BA3F9857

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 1/5/15 1/5/15 - Martin Dugas
  3. 7/29/15 7/29/15 - Martin Dugas
Uploaded on

July 29, 2015

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Creative Commons BY-NC 3.0 Legacy
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Treatment Chemotherapy-docetaxel/capecitabine arm Breast Cancer NCT00433589

English

No Instruction available.

1 forms  
  1. StudyEvent: Chemotherapy-docetaxel/capecitabine arm
    1. No Instruction available.
Header
Description

Header

Alias
UMLS CUI-1
C1320722
Patient date of birth
Description

Patient date of birth

Data type

date

Measurement units
  • DD.MM.YYYY
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25155
UMLS CUI-1-1
C0421451
DD.MM.YYYY
Patient Hospital Number
Description

Patient Hospital No

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C0421459
NCI Thesaurus Property
C16960
NCI Thesaurus Property-2
C25364
NCI Thesaurus ObjectClass
C16696
Institution Name
Description

Institution Name

Data type

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

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Physician of Record
Description

Investigator Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
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
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
Chemotherapy Docetaxel/Capecitabine arm
Description

Chemotherapy Docetaxel/Capecitabine arm

Alias
UMLS CUI-1
C0392920
UMLS CUI-2
C0282564
Date Chemotherapy Began
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
Cycle Number
Description

Cycle Number

Data type

integer

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
Body weight
Description

Body weight

Data type

float

Measurement units
  • kg
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
UMLS CUI-1-1
C0005910
kg
Body surface area
Description

Body surface area

Data type

float

Measurement units
  • m²
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
UMLS CUI-1-1
C0005902
m²
Performance Status
Description

ECOG Performance Status

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Cycle Delayed?
Description

Chemotherapy delayed

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1299577
NCI Thesaurus Property
C25477
NCI Thesaurus Property-2
C25472
NCI Thesaurus ObjectClass
C15368
Total Daily Dose of Agent (or Drug)
Description

Concomitant Medication Daily Dose

Data type

float

Alias
NCI Thesaurus ObjectClass
C25473
UMLS CUI-1
C2826638
NCI Thesaurus ObjectClass-2
C1708
NCI Thesaurus Property
C25304
NCI Thesaurus Property-2
C25256
NCI Thesaurus ValueDomain
C25488
NCI Thesaurus ValueDomain-2
C1708
Were there any dose modifications or additions/omissions to protocol treatment?
Description

Dose Modification

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
Dose modification
Description

Dose Modification Status

Data type

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS CUI-1
C1707811
NCI Thesaurus ValueDomain
C25688
NCI Thesaurus Property
C25572
Reason for therapy modification
Description

Dose Modification Reason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C0392360
NCI Thesaurus Property
C25572
Was treatment modified?
Description

Treatment Modification

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1299575
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25572
Number of Capecitabine Doses Missed
Description

Missed Doses Capecitabine

Data type

integer

Alias
NCI Thesaurus Property
C54031
NCI Thesaurus ObjectClass
C25488
NCI Metathesaurus ValueDomain
CL052797
UMLS CUI-1
C1709043
UMLS CUI-2
C0671970
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No Instruction available.

1 forms
  1. StudyEvent: Chemotherapy-docetaxel/capecitabine arm
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Birth date
Item
Patient date of birth
date
C25164 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)
C0421451 (UMLS CUI-1-1)
Patient Hospital No
Item
Patient Hospital Number
text
C25337 (NCI Thesaurus ValueDomain)
C0421459 (UMLS CUI-1)
C16960 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C16696 (NCI Thesaurus ObjectClass)
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)
Investigator Name
Item
Physician of Record
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Investigator Signature Date
Item
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)
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Item Group
Chemotherapy Docetaxel/Capecitabine arm
C0392920 (UMLS CUI-1)
C0282564 (UMLS CUI-2)
Chemotherapy Start Date
Item
Date Chemotherapy Began
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)
Cycle Number
Item
Cycle Number
integer
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
Weight
Item
Body weight
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
C0005910 (UMLS CUI-1-1)
BSA
Item
Body surface area
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS CUI-1-1)
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.1
Code List
Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
Chemotherapy delayed
Item
Cycle Delayed?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1299577 (UMLS CUI-1)
C25477 (NCI Thesaurus Property)
C25472 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
Concomitant Medication Daily Dose
Item
Total Daily Dose of Agent (or Drug)
float
C25473 (NCI Thesaurus ObjectClass)
C2826638 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C25304 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
C25488 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ValueDomain-2)
Item
Were there any dose modifications or additions/omissions to protocol treatment?
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
CL.3
Code List
Were there any dose modifications or additions/omissions to protocol treatment?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Both Planned And Unplanned (Yes, both planned and unplanned)
Item
Dose modification
text
C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
CL.4
Code List
Dose modification
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Dose Escalated (Dose escalated)
CL Item
Dose Held (Dose held)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS 2011AA-4)
CL Item
Drug Discontinued (Drug discontinued)
CL Item
No Dose Modification (No dose modification)
Item
Reason for therapy modification
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
CL.7
Code List
Reason for therapy modification
CL Item
Hematologic Toxicity (Hematologic toxicity)
Treatment Modification
Item
Was treatment modified?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1299575 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
Missed Doses Capecitabine
Item
Number of Capecitabine Doses Missed
integer
C54031 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ObjectClass)
CL052797 (NCI Metathesaurus ValueDomain)
C1709043 (UMLS CUI-1)
C0671970 (UMLS CUI-2)
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