ID

25182

Beschreibung

Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib; ODM derived from: https://clinicaltrials.gov/show/NCT00474786

Link

https://clinicaltrials.gov/show/NCT00474786

Stichworte

Versionen (1)
  1. 28.08.17 28.08.17 -
Hochgeladen am

28. August 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Renal Cell Carcinoma NCT00474786

Englisch

Eligibility Renal Cell Carcinoma NCT00474786

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed diagnosis of mrcc (regardless of histology or nephrectomy status) with well-documented radiological pd by recist criteria or clinical pd as judged by the investigator while receiving first-line sunitinib therapy. subjects must have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously).
Beschreibung

Metastatic Renal Cell Cancer | Independent of Histology | Independent of Nephrectomy status | Progressive Disease | Sunitinib First line treatment | Sunitinib Course Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0278678
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C4048239
UMLS CUI [3,1]
C0332291
UMLS CUI [3,2]
C1404808
UMLS CUI [4]
C1335499
UMLS CUI [5,1]
C1176020
UMLS CUI [5,2]
C1708063
UMLS CUI [6,1]
C1176020
UMLS CUI [6,2]
C0750729
UMLS CUI [6,3]
C1265611
at time of randomization, at least 2 weeks since prior treatment with sunitinib, palliative radiation therapy, and/or surgery.
Beschreibung

Sunitinib | Palliative Radiation Therapy | Palliative Surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C1176020
UMLS CUI [2]
C3898008
UMLS CUI [3]
C0282282
at time of randomization, there must be at least 1 measurable lesion per recist. lesions that have been previously irradiated or embolized cannot be selected as target lesions.
Beschreibung

Measurable lesion Quantity | Therapeutic radiology procedure Lesion Excluded | Therapeutic Embolization Lesion Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C2828389
UMLS CUI [3,1]
C0013931
UMLS CUI [3,2]
C0221198
UMLS CUI [3,3]
C2828389
more criteria apply
Beschreibung

Criteria Additional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1524062
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
metastatic cns from rcc.
Beschreibung

CNS metastases Due to Renal Cell Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0007134
subjects who discontinued sutent therapy due specifically to intolerance.
Beschreibung

Sutent Discontinued | Intolerance to Sutent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1698963
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1698963
prior systemic therapy for mrcc other than sunitinib.
Beschreibung

Systemic therapy Metastatic Renal Cell Cancer | Exception Sunitinib

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0278678
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1176020
active ketonuria, secondary to poorly controlled diabetes mellitus
Beschreibung

Ketonuria | Secondary diabetes mellitus | Diabetes mellitus poor control

Datentyp

boolean

Alias
UMLS CUI [1]
C0162275
UMLS CUI [2]
C0271640
UMLS CUI [3]
C0860161
more criteria apply
Beschreibung

Criteria Additional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1524062
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Ähnliche Modelle

Eligibility Renal Cell Carcinoma NCT00474786

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Metastatic Renal Cell Cancer | Independent of Histology | Independent of Nephrectomy status | Progressive Disease | Sunitinib First line treatment | Sunitinib Course Quantity
Item
histologically confirmed diagnosis of mrcc (regardless of histology or nephrectomy status) with well-documented radiological pd by recist criteria or clinical pd as judged by the investigator while receiving first-line sunitinib therapy. subjects must have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously).
boolean
C0278678 (UMLS CUI [1])
C0332291 (UMLS CUI [2,1])
C4048239 (UMLS CUI [2,2])
C0332291 (UMLS CUI [3,1])
C1404808 (UMLS CUI [3,2])
C1335499 (UMLS CUI [4])
C1176020 (UMLS CUI [5,1])
C1708063 (UMLS CUI [5,2])
C1176020 (UMLS CUI [6,1])
C0750729 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
Sunitinib | Palliative Radiation Therapy | Palliative Surgery
Item
at time of randomization, at least 2 weeks since prior treatment with sunitinib, palliative radiation therapy, and/or surgery.
boolean
C1176020 (UMLS CUI [1])
C3898008 (UMLS CUI [2])
C0282282 (UMLS CUI [3])
Measurable lesion Quantity | Therapeutic radiology procedure Lesion Excluded | Therapeutic Embolization Lesion Excluded
Item
at time of randomization, there must be at least 1 measurable lesion per recist. lesions that have been previously irradiated or embolized cannot be selected as target lesions.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
C0013931 (UMLS CUI [3,1])
C0221198 (UMLS CUI [3,2])
C2828389 (UMLS CUI [3,3])
Criteria Additional
Item
more criteria apply
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
CNS metastases Due to Renal Cell Carcinoma
Item
metastatic cns from rcc.
boolean
C0686377 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0007134 (UMLS CUI [1,3])
Sutent Discontinued | Intolerance to Sutent
Item
subjects who discontinued sutent therapy due specifically to intolerance.
boolean
C1698963 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1698963 (UMLS CUI [2,2])
Systemic therapy Metastatic Renal Cell Cancer | Exception Sunitinib
Item
prior systemic therapy for mrcc other than sunitinib.
boolean
C1515119 (UMLS CUI [1,1])
C0278678 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1176020 (UMLS CUI [2,2])
Ketonuria | Secondary diabetes mellitus | Diabetes mellitus poor control
Item
active ketonuria, secondary to poorly controlled diabetes mellitus
boolean
C0162275 (UMLS CUI [1])
C0271640 (UMLS CUI [2])
C0860161 (UMLS CUI [3])
Criteria Additional
Item
more criteria apply
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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