ID

11091

Description

CALGB 40601 ELIGIBILITY CHECKLIST NCT00770809 Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=39E2B924-90AB-3340-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=39E2B924-90AB-3340-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

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License

Creative Commons BY-NC 3.0 Legacy
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CALGB 40601 ELIGIBILITY CHECKLIST NCT00770809

English

INSTRUCTIONS: Complete all information on this form. Submit within one week of registration along with the On-Study Form.

1 forms  
Header
Description

Header

CALGB Study No
Description

Protocol ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Description

Trial subject ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Patient demographics
Description

Patient demographics

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
Patient Hospital No.
Description

Medical Record Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution/Affiliate
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group
Description

Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Description

Study Number Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Description

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Eligibility Criteria
Description

Eligibility Criteria

Eligibility criteria
Description

CancerandLeukemiaGroupBPatientInclusionClinicalTrialEligibilityCriteria40601Type

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25442
UMLS 2011AA ObjectClass-2
C1516238
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property-2
C25532
UMLS 2011AA Property-2
C1512693
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Footer Module
Description

Footer Module

Completed by (Last name, First name)
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed (MM DD YYYY)
Description

Date Form Completed

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
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Similar models

INSTRUCTIONS: Complete all information on this form. Submit within one week of registration along with the On-Study Form.

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Protocol ID CALGB
Item
CALGB Study No
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Item Group
Patient demographics
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)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Eligibility Criteria
Item
Eligibility criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25442 (NCI Thesaurus ObjectClass-2)
C1516238 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property-2)
C1512693 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.1
Code List
Eligibility criteria
CL Item
Alt <= 2.5 X Uln (ALT <= 2.5 x ULN)
CL Item
Anc >= 1,000/mcl (ANC >= 1,000/mcl)
CL Item
Ast <= 2.5 X Uln (AST <= 2.5 x ULN)
CL Item
Cardiac Ejection Fraction > 50% By Echocardiogram Or Muga Scan (Cardiac ejection fraction > 50% by echocardiogram or MUGA scan)
CL Item
Clinical Stage Ii-iii Operable Invasive Breast Cancer With Intent To Perform Surgical Resection After Neoadjuvant Therapy (Clinical stage II-III operable invasive breast cancer with intent to perform surgical resection after neoadjuvant therapy)
CL Item
Ecog (zubrod) Ps <= 1; Life Expectancy >=12 Wk (ECOG (Zubrod) Performance Status 0-1)
CL Item
Er/pgr Status Is Known (ER/PgR status is known)
CL Item
Invasive Breast Cancer (Invasive breast cancer)
CL Item
Multicentric Or Bilateral Disease Is Eligible If Target Lesion Meets Eligibility Criteria (Multicentric or bilateral disease is eligible if target lesion meets eligibility criteria)
CL Item
No Medication With Known Potential For Interaction With Lapatinib For At Least 7 Days Prior To Study Entry (No medication with known potential for interaction with lapatinib for at least 7 days prior to study entry)
CL Item
No Prior Chemotherapy, Hormone Therapy, Biologic Or Radiation Therapy With Therapeutic Intent For This Cancer (No prior chemotherapy, hormone therapy, biologic or radiation therapy with therapeutic intent for this cancer)
CL Item
Patient Consents To Undergo Pretreatment Biopsy And To Acquisition Of Tissue Obtained At The Time Of Surgery (Patient consents to undergo pretreatment biopsy and to acquisition of tissue obtained at the time of surgery)
CL Item
Patients Not Pregnant Or Nursing (Patients not pregnant or nursing)
CL Item
Platelet Count >= 100,000/mm^3 (Platelet count >= 100,000/mm^3)
CL Item
Beta-hcg Negative (in Premenopausal Women) (Serum Beta-HCG negative)
CL Item
Target Lesion In Breast Is > 1 Cm By Either Clinical Or Radiographic Measurement. Patients With Axillary Disease As Only Site Are Not Eligible To Participate (Target lesion in breast is > 1 cm by either clinical or radiographic measurement. Patients with axillary disease as only site are not eligible to participate)
CL Item
Bilirubin <= 1.5 X Uln Unless Due To Gilbert's Syndrome (Total Bilirubin <= 1.5 x ULN unless due to Gilbert's Syndrome)
CL Item
Tumors Are Her2 Positive As Defined In Section 4.3 (Tumors are HER2 positive as defined in section 4.3)
CL Item
>= 18 Years Of Age (Women or men at least 18 years of age)
Item Group
Footer Module
Person Completing Form
Item
Completed by (Last name, First name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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