ID

6395

Beschreibung

NSABP Protocol B-40 - Treatment Form for Docetaxel/Gemcitabine Cycles in Groups 3A and 3B 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

Stichworte

Versionen (3)
  1. 18.12.14 18.12.14 - Martin Dugas
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 16.06.15 16.06.15 -
Hochgeladen am

18. Dezember 2014

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00408408 Treatment - NSABP Protocol B-40 - Treatment Form for Docetaxel/Gemcitabine Cycles in Groups 3A and 3B - 2506049v1.0

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: NSABP Protocol B-40 - Treatment Form for Docetaxel/Gemcitabine Cycles in Groups 3A and 3B
    1. No Instruction available.
Unnamed1
Beschreibung

Unnamed1

Patient Initials (Last First Middle)
Beschreibung

PatientInitialsName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
NSABP Patient ID
Beschreibung

PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C15818
UMLS 2011AA Property
C1513905
Unnamed2
Beschreibung

Unnamed2

Institution/Affiliate
Beschreibung

CombinedInstitutionName

Datentyp

text

Treating MD Last Name
Beschreibung

TreatingPhysicianLastName

Datentyp

text

Treating MD First Name
Beschreibung

TreatingPhysicianFirstName

Datentyp

text

Treating MD Phone
Beschreibung

TreatingPhysicianPhoneNumber

Datentyp

text

Person Completing Form, Last Name
Beschreibung

ResponsiblePersonLastName

Datentyp

text

Person Completing Form, First Name
Beschreibung

ResponsiblePersonFirstName

Datentyp

text

Person Completing Form, Phone
Beschreibung

ResponsiblePersonPhoneNumber

Datentyp

text

Are data amended
Beschreibung

DataAmendedInd-3

Datentyp

text

Unnamed3
Beschreibung

Unnamed3

Total Number of Cycles Given (Docetaxel/Gemcitabine)
Beschreibung

TherapyCourseAdministeredCount

Datentyp

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
C25382
UMLS 2011AA Property
C1521801
Why did treatment end or not begin (Docetaxel/Gemcitabine)
Beschreibung

NationalSurgicalAdjuvantBreastandBowelProjectTreatmentNotAdministeredReason

Datentyp

text

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

NationalSurgicalAdjuvantBreastandBowelProjectTherapyNotAdministeredSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15818
UMLS 2011AA ObjectClass
C1513905
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Unnamed4
Beschreibung

Unnamed4

Cycle Number
Beschreibung

TherapyCourseNumber

Datentyp

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Cycle Start Date
Beschreibung

TreatmentCourseBeginDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Agent Name (Docetaxel, Gemcitabine Day 1, Gemcitabine Day 8)
Beschreibung

AgentName

Datentyp

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
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.)
Beschreibung

AgentAdministeredDose

Datentyp

double

Alias
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
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Ähnliche Modelle

No Instruction available.

1 Formulare
  1. StudyEvent: NSABP Protocol B-40 - Treatment Form for Docetaxel/Gemcitabine Cycles in Groups 3A and 3B
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Unnamed1
PatientInitialsName
Item
Patient Initials (Last First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C15818 (NCI Thesaurus Property)
C1513905 (UMLS 2011AA Property)
Item Group
Unnamed2
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
Item
Are data amended
text
CL.1
Code List
Are data amended
CL Item
No (no)
CL Item
Yes (yes)
Item Group
Unnamed3
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)
C1521801 (UMLS 2011AA Property)
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)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
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)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Unnamed4
TherapyCourseNumber
Item
Cycle Number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
TreatmentCourseBeginDate
Item
Cycle Start Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
AgentName
Item
Agent Name (Docetaxel, Gemcitabine Day 1, Gemcitabine Day 8)
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
AgentAdministeredDose
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.)
double
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
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