ID

10972

Description

NSABP Protocol B-40 - Treatment Form for Docetaxel/Gemcitabine Cycles in Groups 3A and 3B NCT00408408 A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR With Each of the Regimens Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1AF9CE89-A16C-4210-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1AF9CE89-A16C-4210-E044-0003BA3F9857

Keywords

Versions (3)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/16/15 6/16/15 -
Uploaded on

June 16, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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NSABP Protocol B-40 - Treatment Form for Docetaxel/Gemcitabine Cycles in Groups 3A and 3B NCT00408408

English

No Instruction available.

1 forms  
  1. StudyEvent: NSABP Protocol B-40 - Treatment Form for Docetaxel/Gemcitabine Cycles in Groups 3A and 3B
    1. No Instruction available.
Header
Description

Header

Patient Initials (Last First Middle)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
NSABP Patient ID
Description

Patient ID NSABP

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1513905
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C15818
Institution/Affiliate
Description

CombinedInstitutionName

Data type

text

Treating MD Last Name
Description

TreatingPhysicianLastName

Data type

text

Treating MD First Name
Description

TreatingPhysicianFirstName

Data type

text

Treating MD Phone
Description

TreatingPhysicianPhoneNumber

Data type

text

Person Completing Form, Last Name
Description

ResponsiblePersonLastName

Data type

text

Person Completing Form, First Name
Description

ResponsiblePersonFirstName

Data type

text

Person Completing Form, Phone
Description

ResponsiblePersonPhoneNumber

Data type

text

Are data amended
Description

DataAmendedInd-3

Data type

boolean

Assessment of Chemotherapy
Description

Assessment of Chemotherapy

Total Number of Cycles Given (Docetaxel/Gemcitabine)
Description

TherapyCourseAdministeredCount

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Why did treatment end or not begin (Docetaxel/Gemcitabine)
Description

NationalSurgicalAdjuvantBreastandBowelProjectTreatmentNotAdministeredReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C15818
UMLS 2011AA ObjectClass
C1513905
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Other, specify
Description

NationalSurgicalAdjuvantBreastandBowelProjectTherapyNotAdministeredSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C15818
UMLS 2011AA ObjectClass
C1513905
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Cycle Number
Description

Cycle Number

Data type

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
Cycle Start Date
Description

Chemotherapy Cycle Start Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1302181
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C3173309
NCI Thesaurus Property
C25379
Agent Name (Docetaxel, Gemcitabine Day 1, Gemcitabine Day 8)
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Agent Dose (per M^2 - mg/m^2 - Dose used to calculate the amount of drug to be administered. In Groups 3A and 3B, full dose of docetaxel is 75 mg/m^2. Full dose of gemcitabine is 1000 mg/m^2.)
Description

Medication Dose

Data type

float

Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain-2
C1708
NCI Thesaurus Property
C25382
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: NSABP Protocol B-40 - Treatment Form for Docetaxel/Gemcitabine Cycles in Groups 3A and 3B
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials
Item
Patient Initials (Last First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient ID NSABP
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
CombinedInstitutionName
Item
Institution/Affiliate
text
TreatingPhysicianLastName
Item
Treating MD Last Name
text
TreatingPhysicianFirstName
Item
Treating MD First Name
text
TreatingPhysicianPhoneNumber
Item
Treating MD Phone
text
ResponsiblePersonLastName
Item
Person Completing Form, Last Name
text
ResponsiblePersonFirstName
Item
Person Completing Form, First Name
text
ResponsiblePersonPhoneNumber
Item
Person Completing Form, Phone
text
DataAmendedInd-3
Item
Are data amended
boolean
Item Group
Assessment of Chemotherapy
Item
Total Number of Cycles Given (Docetaxel/Gemcitabine)
text
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
CL.2
Code List
Total Number of Cycles Given (Docetaxel/Gemcitabine)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
CL Item
4 (4)
Item
Why did treatment end or not begin (Docetaxel/Gemcitabine)
text
C15818 (NCI Thesaurus ObjectClass)
C1513905 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.3
Code List
Why did treatment end or not begin (Docetaxel/Gemcitabine)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Adverse Event/side Effects/complications (Adverse event/side effects/complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
New Lesion (including Second Primary Cancer) Or Other Sign Of Progression (New lesion (including second primary cancer) or other sign of progression)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
NationalSurgicalAdjuvantBreastandBowelProjectTherapyNotAdministeredSpecify
Item
Other, specify
text
C15818 (NCI Thesaurus ObjectClass)
C1513905 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Cycle Number
Item
Cycle Number
float
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
Chemotherapy Cycle Start Date
Item
Cycle Start Date
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C3173309 (UMLS CUI-2)
C25379 (NCI Thesaurus Property)
Agent
Item
Agent Name (Docetaxel, Gemcitabine Day 1, Gemcitabine Day 8)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Medication Dose
Item
Agent Dose (per M^2 - mg/m^2 - Dose used to calculate the amount of drug to be administered. In Groups 3A and 3B, full dose of docetaxel is 75 mg/m^2. Full dose of gemcitabine is 1000 mg/m^2.)
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
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