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)
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)
PatientInitialsName
Item
Patient's Initials
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)
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)
PatientMedicalRecordNumber
Item
Patient Medical Record Number
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)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Protocol Number
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)
CombinedInstitutionName
Item
Main Member Institution/Adjunct
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)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient No.
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)
PatientsmusthavepathologicconfirmationofcompleteresectionofT3-4and/orpelvicnodepositivetransitionalcellcarcinomaofthebladderwithnegativemargins
Item
Patients must have pathologic confirmation of complete resection of T3-4 and/or pelvic node positive transitional cell carcinoma of the bladder with negative margins
text
Pathologicalstagesforpatientswithbladdercancereligibleforthistrialinclude:Tany,N=,Mo;T3a,N0,M0;T3b,N0,M0;T4a,N0,M0
Item
Pathological stages for patients with bladder cancer eligible for this trial include: Tany, N=, Mo; T3a, N0, M0; T3b, N0, M0; T4a, N0, M0
text
Patientsmusthaveundergonecystoprostatectomypluspelviclympnnodedissectionforbladdercancerinmenandcystectomy/totalabdominalhysterectomy/bilateral/salpingo-oophorectomypluspelviclymphnodedissectionforbladdercancerinwomen
Item
Patients must have undergone cystoprostatectomy plus pelvic lympn node dissection for bladder cancer in men and cystectomy/total abdominal hysterectomy/bilateral/salpingo-oophorectomy plus pelvic lymph node dissection for bladder cancer in women
text
Nopriorsystemicchemotherapyforanyreasonorirradiationofthebladder
Item
No prior systemic chemotherapy for any reason or irradiation of the bladder
text
Greaterthanorequalto6weekssincethedefinitivesurgerybutnotmorethan3years
Item
Greater than or equal to 6 weeks since the definitive surgery but not more than 3 years
text
Paraffintissueblocksorunstainedslidesoftheprimarytumorforimmunohistochemicalstudiesmustbeavailable
Item
Paraffin tissue blocks or unstained slides of the primary tumor for immunohistochemical studies must be available
text
Noevidenceofanotheractivecancerwithin5yearspriortoregistration,exceptfornon-melanomacarcinomaoftheskinorinsitucarcinomaofthecervixcurativelytreated.Patientswhohaveaprostatecancerintheresectedspecimenareeligible,pro
Item
No evidence of another active cancer within 5 years prior to registration, except for non-melanoma carcinoma of the skin or in situ carcinoma of the cervix curatively treated. Patients who have a prostate cancer in the resected specimen are eligible, pro
text
Normalcardiacfunction,noevidenceofNYHAfunctionalclassIIIorIVheartdisease
Item
Normal cardiac function, no evidence of NYHA functional class III or IV heart disease
text
Normalcardiacfunction,patientsmusthavenoseriouscardiacarrhythmias;includingfirst,secondandthirddegreeheartblock
Item
Normal cardiac function, patients must have no serious cardiac arrhythmias; including first, second and third degree heart block
text
ECOGperformacestatus0-1
Item
ECOG performace status 0-1
text
Age>=18years
Item
Age greater than or equal to 18 years
text
ANCgreaterthanorequalto1500/mm^3
Item
ANC greater than or equal to 1500/mm^3
text
Plateletcountgreaterthanorequalto150,000/mm^3
Item
Platelet count greater than or equal to 150,000/mm^3
text
Bilirubinlessthanorequalto1.5xULN
Item
Bilirubin less than or equal to 1.5 x ULN
text
LaboratoryProcedureCreatinineEligibilityDeterminationind-2
Item
Serum creatinine less than 1.5 mg/dl or calculated creatinine clearance greater than or equal to 60 ml/min/1.73m^2 using Cockcroft-Gault equation
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
Alkalinephosphataselessthan2.0xULN
Item
Alkaline phosphatase less than 2.0 x ULN
text
ASTlessthan2.0xULN
Item
AST less than 2.0 x ULN
text
LaboratoryProcedureNeutrophilResultSpecifiedValue
Item
ANC patient's value
double
C12533 (NCI Thesaurus Property)
C0027950 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedurePlateletResultSpecifiedValue
Item
Platelet count patient's value
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
HepaticBilirubinLabUpperLimitNormalValue
Item
Bilirubin ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Hepatic,Bilirubin
Item
Bilirubin Patient's value
double
RenalCreatinineLabSpecifiedValue
Item
Serum creatinine patient's value
double
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue
Item
Alkaline phosphatase ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Hepatic,AlkalinePhosphatase
Item
Alkaline phosphatase patient's value
double
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
AST ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
HepaticSGOT(AST)LabUnspecifiedValue
Item
AST patient's value
double
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
ResponsiblePersonName
Item
Completed by
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)
FormCompleteDate
Item
Date
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)