ID

11137

Description

CALGB 90601: Eligibility Checklist NCT00942331 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

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=657F334E-CCEE-8AE9-E040-BB89AD43469A

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/21/15 6/21/15 -
Uploaded on

June 21, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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CALGB 90601: Eligibility Checklist NCT00942331

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

Patient eligibility
Description

CancerandLeukemiaGroupBPatientInclusionClinicalTrialEligibilityCriteria90601Type

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
Patient eligibility
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
Patient eligibility
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)
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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