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Information:
Fel:
ID
38367
Beskrivning
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
Länk
https://clinicaltrials.gov/show/NCT01035229
Nyckelord
Versioner (2)
- 2019-10-13 2019-10-13 -
- 2021-09-20 2021-09-20 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
13 oktober 2019
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Carcinoma NCT01035229
Eligibility Carcinoma NCT01035229
- StudyEvent: Eligibility
Similar models
Eligibility Carcinoma NCT01035229
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Malignant neoplasm of liver Advanced
Item
advanced liver cancer
boolean
C0345904 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C2348563 (UMLS CUI [1,2])