ID

11472

Beschrijving

NSABP Protocol B-40 - Postoperative Adjuvant Treatments 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=1B7DA758-8A3B-186C-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B7DA758-8A3B-186C-E044-0003BA3F9857

Trefwoorden

  1. 18-12-14 18-12-14 - Martin Dugas
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 05-07-15 05-07-15 -
Geüploaded op

5 juli 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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NSABP Protocol B-40 - Postoperative Adjuvant Treatments NCT00408408

Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

Header
Beschrijving

Header

Patient Initials (Last First Middle)
Beschrijving

Patient Initials

Datatype

text

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

Patient ID NSABP

Datatype

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
Person Completing Form
Beschrijving

Person Completing Form

Institution/Affiliate
Beschrijving

CombinedInstitutionName

Datatype

text

Person Completing Form, Last Name
Beschrijving

ResponsiblePersonLastName

Datatype

text

Person Completing Form, First Name
Beschrijving

ResponsiblePersonFirstName

Datatype

text

Person Completing Form, Phone
Beschrijving

ResponsiblePersonPhoneNumber

Datatype

text

Date Form Completed
Beschrijving

Date Form Completed

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
Are data amended
Beschrijving

DataAmendedInd-3

Datatype

boolean

Postoperative Radiation Therapy (RT)
Beschrijving

Postoperative Radiation Therapy (RT)

Post-lumpectomy breast RT
Beschrijving

BreastRadiationTherapyPostLumpectomyAdministrationInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C15755
UMLS 2011AA Property
C0024885
NCI Thesaurus Property-2
C38008
UMLS 2011AA Property-2
C0687676
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Post-mastectomy chest wall RT
Beschrijving

ChestWallRadiationTherapyPostMastectomyAdministrationInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C62484
UMLS 2011AA ObjectClass-2
C0205076
NCI Thesaurus Property
C15277
UMLS 2011AA Property
C0024881
NCI Thesaurus Property-2
C38008
UMLS 2011AA Property-2
C0687676
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Regional nodal RT
Beschrijving

RegionalLymphNodeRadiationTherapyAdministrationInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ObjectClass-2
C49018
UMLS 2011AA ObjectClass-2
C1184738
Postoperative Systemic Adjuvant Therapy
Beschrijving

Postoperative Systemic Adjuvant Therapy

Postoperative Adjuvant Hormonal Therapy
Beschrijving

AdjuvantHormoneTherapyPostoperativeAdministeredInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
NCI Thesaurus Property
C28006
UMLS 2011AA Property
C0032790
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Postoperative Bevacizumab
Beschrijving

BevacizumabChemotherapyPostoperativeAdministeredInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C2039
UMLS 2011AA ObjectClass-2
C0796392
NCI Thesaurus Property
C28006
UMLS 2011AA Property
C0032790
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Postoperative Trastuzumab
Beschrijving

TrastuzumabAgentPostoperativeAdministrationInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C1647
UMLS 2011AA ObjectClass
C0338204
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C28006
UMLS 2011AA Property
C0032790
NCI Thesaurus Property-2
C25409
UMLS 2011AA Property-2
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Postoperative Chemotherapy
Beschrijving

ChemotherapyPostoperativeAdministeredInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C28006
UMLS 2011AA Property
C0032790
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Other
Beschrijving

AdjuvantTherapyPostoperativeOtherAdministeredInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15675
UMLS 2011AA ObjectClass
C0677850
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C28006
UMLS 2011AA Property-2
C0032790
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Specify (If yes)
Beschrijving

AdjuvantTherapyPostoperativeOtherAdministeredSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15675
UMLS 2011AA ObjectClass
C0677850
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C28006
UMLS 2011AA Property-2
C0032790
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902

Similar models

Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)
Item Group
Person Completing Form
CombinedInstitutionName
Item
Institution/Affiliate
text
ResponsiblePersonLastName
Item
Person Completing Form, Last Name
text
ResponsiblePersonFirstName
Item
Person Completing Form, First Name
text
ResponsiblePersonPhoneNumber
Item
Person Completing Form, Phone
text
Date Form Completed
Item
Date Form Completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
DataAmendedInd-3
Item
Are data amended
boolean
Item Group
Postoperative Radiation Therapy (RT)
BreastRadiationTherapyPostLumpectomyAdministrationInd-2
Item
Post-lumpectomy breast RT
boolean
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C15755 (NCI Thesaurus Property)
C0024885 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ChestWallRadiationTherapyPostMastectomyAdministrationInd-2
Item
Post-mastectomy chest wall RT
boolean
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C62484 (NCI Thesaurus ObjectClass-2)
C0205076 (UMLS 2011AA ObjectClass-2)
C15277 (NCI Thesaurus Property)
C0024881 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
RegionalLymphNodeRadiationTherapyAdministrationInd-2
Item
Regional nodal RT
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C49018 (NCI Thesaurus ObjectClass-2)
C1184738 (UMLS 2011AA ObjectClass-2)
Item Group
Postoperative Systemic Adjuvant Therapy
AdjuvantHormoneTherapyPostoperativeAdministeredInd-3
Item
Postoperative Adjuvant Hormonal Therapy
boolean
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C28006 (NCI Thesaurus Property)
C0032790 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
BevacizumabChemotherapyPostoperativeAdministeredInd-2
Item
Postoperative Bevacizumab
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C2039 (NCI Thesaurus ObjectClass-2)
C0796392 (UMLS 2011AA ObjectClass-2)
C28006 (NCI Thesaurus Property)
C0032790 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
TrastuzumabAgentPostoperativeAdministrationInd-2
Item
Postoperative Trastuzumab
boolean
C1647 (NCI Thesaurus ObjectClass)
C0338204 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C28006 (NCI Thesaurus Property)
C0032790 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ChemotherapyPostoperativeAdministeredInd-2
Item
Postoperative Chemotherapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C28006 (NCI Thesaurus Property)
C0032790 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
AdjuvantTherapyPostoperativeOtherAdministeredInd-2
Item
Other
boolean
C15675 (NCI Thesaurus ObjectClass)
C0677850 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C28006 (NCI Thesaurus Property-2)
C0032790 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
AdjuvantTherapyPostoperativeOtherAdministeredSpecify
Item
Specify (If yes)
text
C15675 (NCI Thesaurus ObjectClass)
C0677850 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C28006 (NCI Thesaurus Property-2)
C0032790 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

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