ID

38367

Beschrijving

Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.; ODM derived from: https://clinicaltrials.gov/show/NCT01035229

Link

https://clinicaltrials.gov/show/NCT01035229

Trefwoorden

Versies (2)
  1. 13-10-19 13-10-19 -
  2. 20-09-21 20-09-21 -
Houder van rechten

See clinicaltrials.gov

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13 oktober 2019

DOI

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Creative Commons BY 4.0
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Eligibility Carcinoma NCT01035229

Engels

Eligibility Carcinoma NCT01035229

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT01035229
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
advanced liver cancer
Beschrijving

Malignant neoplasm of liver Advanced

Datatype

boolean

Alias
UMLS CUI [1,1]
C0345904
UMLS CUI [1,2]
C0205179
prior systemic treatment with sorafenib for advanced hcc and for whom their disease progressed during or after sorafenib treatment, or were intolerant to sorafenib treatment. specifically, this can be defined as:
Beschrijving

Systemic therapy Liver carcinoma Advanced | sorafenib | Disease Progression | Intolerance to Sorafenib

Datatype

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C2239176
UMLS CUI [1,3]
C0205179
UMLS CUI [2]
C1516119
UMLS CUI [3]
C0242656
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C1516119
documented radiological confirmation (radiology scans or report) of disease progression during or after sorafenib treatment
Beschrijving

Disease Progression Radiology | sorafenib

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0043299
UMLS CUI [2]
C1516119
intolerance to sorafenib (at any dose and/or duration) is defined as documented sorafenib-related grade 3 or 4 adverse events that led to sorafenib discontinuation.
Beschrijving

intolerance to Sorafenib Dose Any | Sorafenib Relationship CTCAE Grades | Sorafenib Discontinuation

Datatype

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1516119
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C1552551
UMLS CUI [2,1]
C1516119
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C1516728
UMLS CUI [3,1]
C1516119
UMLS CUI [3,2]
C1444662
note:
Beschrijving

Annotation

Datatype

boolean

Alias
UMLS CUI [1]
C1706814
sorafenib must be the last antineoplastic treatment before randomization
Beschrijving

sorafenib | Cancer treatment Last

Datatype

boolean

Alias
UMLS CUI [1]
C1516119
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C1517741
prior local and/or hormonal therapy (e.g., tamoxifen) before sorafenib is allowed
Beschrijving

Local Therapy | Hormone Therapy | Tamoxifen

Datatype

boolean

Alias
UMLS CUI [1]
C1517925
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0039286
one systemic chemotherapy regimen for advanced hcc is allowed before sorafenib treatment
Beschrijving

Systemic Chemotherapy Liver carcinoma Advanced

Datatype

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C2239176
UMLS CUI [1,3]
C0205179
ecog performance status of ≤ 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
child-pugh a
Beschrijving

Child-Pugh Classification

Datatype

boolean

Alias
UMLS CUI [1]
C2347612
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
active bleeding during the last 28 days
Beschrijving

Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1]
C0019080
prior therapy with mtor inhibitors
Beschrijving

mTOR Inhibitor

Datatype

boolean

Alias
UMLS CUI [1]
C2746052
prior liver or other organ transplantation which mandates systemic immunosuppression
Beschrijving

Transplantation of liver | Organ Transplantation | Therapeutic immunosuppression Systemic mandatory

Datatype

boolean

Alias
UMLS CUI [1]
C0023911
UMLS CUI [2]
C0029216
UMLS CUI [3,1]
C0021079
UMLS CUI [3,2]
C0205373
UMLS CUI [3,3]
C1514873
other protocol-defined inclusion/exclusion criteria may apply
Beschrijving

Eligibility Criteria Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Carcinoma NCT01035229

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT01035229
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Malignant neoplasm of liver Advanced
Item
advanced liver cancer
boolean
C0345904 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Systemic therapy Liver carcinoma Advanced | sorafenib | Disease Progression | Intolerance to Sorafenib
Item
prior systemic treatment with sorafenib for advanced hcc and for whom their disease progressed during or after sorafenib treatment, or were intolerant to sorafenib treatment. specifically, this can be defined as:
boolean
C1515119 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C1516119 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C1516119 (UMLS CUI [4,2])
Disease Progression Radiology | sorafenib
Item
documented radiological confirmation (radiology scans or report) of disease progression during or after sorafenib treatment
boolean
C0242656 (UMLS CUI [1,1])
C0043299 (UMLS CUI [1,2])
C1516119 (UMLS CUI [2])
intolerance to Sorafenib Dose Any | Sorafenib Relationship CTCAE Grades | Sorafenib Discontinuation
Item
intolerance to sorafenib (at any dose and/or duration) is defined as documented sorafenib-related grade 3 or 4 adverse events that led to sorafenib discontinuation.
boolean
C1744706 (UMLS CUI [1,1])
C1516119 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1552551 (UMLS CUI [1,4])
C1516119 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
C1516119 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
Annotation
Item
note:
boolean
C1706814 (UMLS CUI [1])
sorafenib | Cancer treatment Last
Item
sorafenib must be the last antineoplastic treatment before randomization
boolean
C1516119 (UMLS CUI [1])
C0920425 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
Local Therapy | Hormone Therapy | Tamoxifen
Item
prior local and/or hormonal therapy (e.g., tamoxifen) before sorafenib is allowed
boolean
C1517925 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0039286 (UMLS CUI [3])
Systemic Chemotherapy Liver carcinoma Advanced
Item
one systemic chemotherapy regimen for advanced hcc is allowed before sorafenib treatment
boolean
C1883256 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
ECOG performance status
Item
ecog performance status of ≤ 2
boolean
C1520224 (UMLS CUI [1])
Child-Pugh Classification
Item
child-pugh a
boolean
C2347612 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hemorrhage
Item
active bleeding during the last 28 days
boolean
C0019080 (UMLS CUI [1])
mTOR Inhibitor
Item
prior therapy with mtor inhibitors
boolean
C2746052 (UMLS CUI [1])
Transplantation of liver | Organ Transplantation | Therapeutic immunosuppression Systemic mandatory
Item
prior liver or other organ transplantation which mandates systemic immunosuppression
boolean
C0023911 (UMLS CUI [1])
C0029216 (UMLS CUI [2])
C0021079 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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