ID

25182

Description

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

Keywords

  1. 8/28/17 8/28/17 -
Uploaded on

August 28, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Renal Cell Carcinoma NCT00474786

Eligibility Renal Cell Carcinoma NCT00474786

Inclusion Criteria
Description

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).
Description

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

Data type

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.
Description

Sunitinib | Palliative Radiation Therapy | Palliative Surgery

Data type

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.
Description

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

Data type

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
Description

Criteria Additional

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
metastatic cns from rcc.
Description

CNS metastases Due to Renal Cell Carcinoma

Data type

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.
Description

Sutent Discontinued | Intolerance to Sutent

Data type

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.
Description

Systemic therapy Metastatic Renal Cell Cancer | Exception Sunitinib

Data type

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
Description

Ketonuria | Secondary diabetes mellitus | Diabetes mellitus poor control

Data type

boolean

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

Criteria Additional

Data type

boolean

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

Similar models

Eligibility Renal Cell Carcinoma NCT00474786

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial