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537
Description
CALGB 90601: Eligibility Checklist Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=657F334E-CCEE-8AE9-E040-BB89AD43469A
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Versions (3)
- 8/26/12 8/26/12 -
- 1/9/15 1/9/15 - Martin Dugas
- 6/21/15 6/21/15 -
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August 26, 2012
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Creative Commons BY-NC 3.0 Legacy
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Bladder Cancer NCT00942331 Eligibility - CALGB 90601: Eligibility Checklist - 2853825v1.0
INSTRUCTIONS: Complete all information on this form. Submit within one week of registration along with the On-Study Form.
- StudyEvent: CALGB 90601: Eligibility Checklist
Similar models
INSTRUCTIONS: Complete all information on this form. Submit within one week of registration along with the On-Study Form.
- StudyEvent: CALGB 90601: Eligibility Checklist
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
ProtocolCALGBIdentifierNumber
Item
CALGB Study No
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
PatientCALGBIdentifierNumber
Item
CALGB 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)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
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)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientMedicalRecordNumber
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
ParticipatingGroupName
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item
Patient eligibility
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property)
C1512693 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C0030705 (UMLS 2011AA ObjectClass)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property)
C1512693 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL Item
>= 4 Weeks From Any Intravesical Therapy (>= 4 weeks from any intravesical therapy)
CL Item
>= 4 Weeks Since Any Radiation Therapy (including Palliative) Or Major Surgery And Fully Recovered (>= 4 weeks since any radiation therapy (including palliative) or major surgery and fully recovered)
CL Item
Age >= 18 Yrs (Age >= 18 yrs)
CL Item
Anc >= 1500/mcl (ANC >= 1500/mcl)
CL Item
Ast <= 2.0 X Uln (AST <= 2.0 x ULN)
CL Item
Bilirubin <= 1.25 X Uln (Bilirubin <= 1.25 x ULN)
CL Item
Calculated Creatinine Clearance >= 60 Ml/min (Calculated Creatinine Clearance >= 60 mL/min)
CL Item
Ecog Performance Status: 0-1 (ECOG Performance Status: 0-1)
CL Item
Histologically Documented Metastatic Or Unresectable Transitional Cell Carcinoma Of The Urinary Tract With Progressive Metastatic Disease Or Locally Advanced Disease (Histologically documented metastatic or unresectable transitional cell carcinoma of the urinary tract with)
CL Item
No Arterial Thrombotic Events Within 6 Months (No arterial thrombotic events within 6 months)
CL Item
No Clinically Significant Peripheral Arterial Disease (No clinically significant peripheral arterial disease)
CL Item
No Clinically Significant Peripheral Neuropathy (grade >= 2) (No clinically significant peripheral neuropathy (grade >= 2))
CL Item
No Current Congestive Heart Failure (nyha Class Ii Or Higher) (No current congestive heart failure (NYHA Class II or higher))
CL Item
No History Of Gastrointestinal Perforation Within 12 Months Of Registration (No history of gastrointestinal perforation within 12 months of registration)
CL Item
No Known Brain Metastases (brain Imaging (mri/ct) Is Not Required) (No known brain metastases (brain imaging (MRI/CT) is not required))
CL Item
No Known Hypersensitivity To Chinese Hamster Ovary Cell Products (No known hypersensitivity to Chinese hamster ovary cell products)
CL Item
No Prior Bevicizumab/ Or Other Angiogenesis Inhibitors (No prior bevicizumab/ or other angiogenesis inhibitors)
CL Item
No Prior Combination Chemotherapy For Metastatic Disease (No prior combination chemotherapy for metastatic disease)
CL Item
No Serious Or Non-healing Wound, Ulcer Or Bone Fracture (No serious or non-healing wound, ulcer or bone fracture)
CL Item
No Significant History Of Bleeding Events Within 6 Months Of Registration (No significant history of bleeding events within 6 months of registration)
CL Item
Not Pregnant Or Nursing (Not pregnant or nursing)
CL Item
Patients On Full-dose Anticoagulants Must Be On A Stable Dose Of Warfarin And Have An In-range Inr Or Be On A Stable Dose Of Lmw Heparin (Patients on full-dose anticoagulants must be on a stable dose of warfarin and have an in-range INR or be on a stable dose of LMW heparin)
CL Item
Patients With History Of Hypertension Must Be Well Controlled (< 150/90) (Patients with history of hypertension must be well controlled (< 150/90))
CL Item
Platelet Count >= 100,000/mm^3 (Platelet count >= 100,000/mm^3)
CL Item
Prior Neoadjuvant / Adjuvant Chemotherapy Is Permissible (Prior neoadjuvant / adjuvant chemotherapy is permissible)
ResponsiblePersonName
Item
Completed by (Last name, First name)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompleteDate
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)