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Description
CALGB: 40101 PRE-STUDY ELIGIBILITY CHECKLIST Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A4CFBF75-6AD3-69D3-E034-080020C9C0E0
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- 8/26/12 8/26/12 -
- 7/8/15 7/8/15 -
- 7/8/15 7/8/15 -
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August 26, 2012
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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00041119 Eligibility - CALGB: 40101 PRE-STUDY ELIGIBILITY CHECKLIST - 2039130v3.0
INSTRUCTIONS: Complete all information on this form. Do not leave any entries blank.
- StudyEvent: CALGB: 40101 PRE-STUDY ELIGIBILITY CHECKLIST
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INSTRUCTIONS: Complete all information on this form. Do not leave any entries blank.
- StudyEvent: CALGB: 40101 PRE-STUDY ELIGIBILITY CHECKLIST
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
CALGBProtocolNumber
Item
CALGB Study No.
text
CALGBPatientID
Item
CALGB Patient ID
text
Patient'sName
Item
Patient's Name
text
ParticipatingGroup
Item
Participating Group
text
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientHospitalNumber
Item
Patient Hospital Number
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
MainMemberInstitution/Adjunct
Item
Main Member Institution/Adjunct
text
ParticipatingGroupPatientNo.
Item
Participating Group Patient No.
text
Histologicallyconfirmedinvasivecarcinomaofthebreast
Item
Histologically confirmed invasive carcinoma of the breast
text
Undergoneeithermodifiedradicalmastectomyorlumpectomy
Item
Undergone either modified radical mastectomy or lumpectomy
text
NegativetumormarginsforinvasivecancerandDCISincaseofmastectomyorlumpectomy
Item
Negative tumor margins for invasive cancer and DCIS in case of mastectomy or lumpectomy
text
Nolocallyadvancedbreastcancer,inflammatorybreastcancerormetastaticbreastcancer
Item
No locally advanced breast cancer, inflammatory breast cancer or metastatic breast cancer
text
Noinvolvementofdermallymphaticsonpathology
Item
No involvement of dermal lymphatics on pathology
text
"High-risk"node-negativebreastcancer
Item
"High-risk" node-negative breast cancer (guidelines are ER/PgR positive primary tumor >= 1 cm in greatest diameter, or ER/PgR negative tumor of any size; physician discretion is allowed)
text
Negativesentinelnodebiopsy,and/oranaxillarydissectionwhereatleast6lymphnodesareremovedandfoundtobenegative
Item
Negative sentinel node biopsy, and/or an axillary dissection where at least 6 lymph nodes are removed and found to be negative
text
Nopreviouschemotherapyorhormonaltherapy(exceptfortamoxifenasdescribedintheprotocol)forthismalignancy
Item
No previous chemotherapy or hormonal therapy (except for tamoxifen as described in the protocol) for this malignancy
text
Age>=18years
Item
Age >= 18 years
text
CTCPerformancestatus0-1
Item
CTC Performance status 0-1
text
Non-pregnantandnon-nursing
Item
Non-pregnant and non-nursing
text
Noactivecongestiveheartfailurenormyocardialinfarctionwithin6monthspriortoregistration
Item
No active congestive heart failure nor myocardial infarction within 6 months prior to registration
text
Disease-freeofpriorinvasivemalignanciesfor>5yearsexceptforcurativelytreatedbasalcellorsquamouscellcarcinomaoftheskinorcarcinomainsituofthecervix
Item
Disease-free of prior invasive malignancies for >5 years except for curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
text
Willingtostopexogenoushormonetherapy,includingoralcontraceptives,post-menopausalhormonereplacementtherapy,andraloxifene
Item
Willing to stop exogenous hormone therapy, including oral contraceptives, post-menopausal hormone replacement therapy, and raloxifene
text
Discontinuedtamoxifenattimeofenrollmenttostudyiftamoxifenhasbeenreceivedasbreastcancerpreventiveagent,orastreatmentforthismalignancyfor<=4weeks.
Item
Discontinued tamoxifen at time of enrollment to study if tamoxifen has been received as breast cancer preventive agent, or as treatment for this malignancy for <= 4 weeks. (If latter, indicate dates below)
text
Datetamoxifenstarted
Item
Date tamoxifen started
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Datetamoxifendiscontinued
Item
Date tamoxifen discontinued
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
MeetsALLofthefollowinglaboratorycriteriacompletedwithin16daysbeforeregistration
Item
Meets ALL of the following laboratory criteria completed within 16 days before registration
text
ANC>=1000/mcL
Item
ANC >= 1000/mcL
text
Dateobtained(ANC)
Item
Date obtained (ANC)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Platelets>=100,000/mcL
Item
Platelets >= 100,000/mcL
text
Dateobtained(Platelets)
Item
Date obtained (Platelets)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Creatinine<=2.0mg/dL
Item
Creatinine <= 2.0 mg/dL
text
Dateobtained(Creatinine)
Item
Date obtained (Creatinine)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
TotalBilirubin<1.5xupperlimitsofnormaloflaboratory
Item
Total Bilirubin < 1.5 x upper limits of normal of laboratory (mg/dL)
text
Dateobtained(TotalBilirubin)
Item
Date obtained (Total Bilirubin)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
ULN(TotalBilirubin)
Item
ULN (Total Bilirubin)
text
<=84dayssincelastmajorbreastsurgery
Item
<= 84 days since last major breast surgery
text