ID

33220

Beskrivning

Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01490437

Länk

https://clinicaltrials.gov/show/NCT01490437

Nyckelord

Versioner (1)
  1. 2018-12-01 2018-12-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 december 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Urothelial Carcinoma NCT01490437

Engelsk

Eligibility Urothelial Carcinoma NCT01490437

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic or cytologic diagnosis of urothelial (transitional cell) carcinoma with the exception of micropapillary subtype
Beskrivning

Urothelial Carcinoma | Exception Micropapillary transitional cell carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C2145472
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1266012
patients must have recurrent disease (locally advanced or metastatic) that is not amenable to local therapy or newly diagnosed distant metastatic disease
Beskrivning

Recurrent disease Advanced Locally | Metastatic/Recurrent Disease | Local Therapy Unsuccessful | Distant metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C1334739
UMLS CUI [3,1]
C1517925
UMLS CUI [3,2]
C1272705
UMLS CUI [4]
C1269798
measurable disease defined by recist v.1.0
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
ecog performance status of 2 or better
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ and bone marrow function defined as
Beskrivning

Organ function | Bone Marrow function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
other tumor type than urothelial carcinoma
Beskrivning

Cancer Other | Exception Urothelial Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2145472
presence or history of cns metastasis
Beskrivning

CNS metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
prior systemic chemotherapy or immunotherapy (but prior local intravesical chemotherapy or immunotherapy was allowed. and recurrent disease after adjuvant or neoadjuvant cisplatin-based systemic chemotherapy is allowed if the last chemotherapy was administered 1 year or more before the patient enrollment.)
Beskrivning

Systemic Chemotherapy | Prior Immunotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2]
C1514461
presence of second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
Beskrivning

Second Primary Cancers | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
peripheral sensory neuropathy grade 2 or worse
Beskrivning

Peripheral sensory neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0151313
UMLS CUI [1,2]
C1516728
other serious illness or medical conditions
Beskrivning

Illness Serious | Other medical condition Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
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Similar models

Eligibility Urothelial Carcinoma NCT01490437

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Urothelial Carcinoma | Exception Micropapillary transitional cell carcinoma
Item
histologic or cytologic diagnosis of urothelial (transitional cell) carcinoma with the exception of micropapillary subtype
boolean
C2145472 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1266012 (UMLS CUI [2,2])
Recurrent disease Advanced Locally | Metastatic/Recurrent Disease | Local Therapy Unsuccessful | Distant metastasis
Item
patients must have recurrent disease (locally advanced or metastatic) that is not amenable to local therapy or newly diagnosed distant metastatic disease
boolean
C0277556 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1334739 (UMLS CUI [2])
C1517925 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
C1269798 (UMLS CUI [4])
Measurable Disease
Item
measurable disease defined by recist v.1.0
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 2 or better
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
adequate organ and bone marrow function defined as
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Urothelial Carcinoma
Item
other tumor type than urothelial carcinoma
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2145472 (UMLS CUI [2,2])
CNS metastases
Item
presence or history of cns metastasis
boolean
C0686377 (UMLS CUI [1])
Systemic Chemotherapy | Prior Immunotherapy
Item
prior systemic chemotherapy or immunotherapy (but prior local intravesical chemotherapy or immunotherapy was allowed. and recurrent disease after adjuvant or neoadjuvant cisplatin-based systemic chemotherapy is allowed if the last chemotherapy was administered 1 year or more before the patient enrollment.)
boolean
C1883256 (UMLS CUI [1])
C1514461 (UMLS CUI [2])
Second Primary Cancers | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated
Item
presence of second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Peripheral sensory neuropathy CTCAE Grades
Item
peripheral sensory neuropathy grade 2 or worse
boolean
C0151313 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Illness Serious | Other medical condition Serious
Item
other serious illness or medical conditions
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
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