ID

17554

Beschrijving

Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Patients With Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00142467

Link

https://clinicaltrials.gov/show/NCT00142467

Trefwoorden

Versies (1)
  1. 23-09-16 23-09-16 -
Geüploaded op

23 september 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00142467

Engels

Eligibility Hepatocellular Carcinoma NCT00142467

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
unresectable or metastatic hepatocellular carcinoma
Beschrijving

Liver cell carcinoma non-resectable | Metastatic hepatocellular carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C1112459
UMLS CUI [2]
C0744869
measurable tumors
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
adequate hepatic function: total bilirubin < 3.0mg/dl; ast < 7x uln
Beschrijving

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
adequate bone marrow function: anc > 1,000/mm3; platelets > 75,000/mm3
Beschrijving

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
inr < 1.5 for those who are not on anticoagulation
Beschrijving

INR | Anticoagulation Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0525032
UMLS CUI [2]
C0003281
up to two prior chemotherapy regimens for hepatocellular carcinoma
Beschrijving

Prior Chemotherapy Quantity Liver carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2239176
18 years of age or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0-1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of > 12 weeks
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically apparent central nervous system metastases or carcinomatous meningitis
Beschrijving

CNS metastases apparent Clinical | Meningeal Carcinomatosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0750489
UMLS CUI [1,3]
C0205210
UMLS CUI [2]
C0220654
uncontrolled serious medical or psychiatric illness
Beschrijving

Illness Serious Uncontrolled | Mental disorders

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2]
C0004936
pregnant or lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
current or recent (within 4 weeks of first study infusion) participation in experimental study drug
Beschrijving

Study Subject Participation Status | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
uncontrolled hypertension
Beschrijving

Uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
significant proteinuria
Beschrijving

Proteinuria Significant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033687
UMLS CUI [1,2]
C0750502
serious, non-healing wound, ulcer, or bone fracture
Beschrijving

Non-healed wound Serious | Ulcer | Fracture

Datatype

boolean

Alias
UMLS CUI [1,1]
C0750433
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0041582
UMLS CUI [3]
C0016658
evidence of bleeding diathesis or coagulopathy
Beschrijving

Bleeding tendency Evidence of | Blood Coagulation Disorders Evidence of

Datatype

boolean

Alias
UMLS CUI [1,1]
C1458140
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0005779
UMLS CUI [2,2]
C0332120
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Similar models

Eligibility Hepatocellular Carcinoma NCT00142467

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Liver cell carcinoma non-resectable | Metastatic hepatocellular carcinoma
Item
unresectable or metastatic hepatocellular carcinoma
boolean
C1112459 (UMLS CUI [1])
C0744869 (UMLS CUI [2])
Measurable Disease
Item
measurable tumors
boolean
C1513041 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement
Item
adequate hepatic function: total bilirubin < 3.0mg/dl; ast < 7x uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
adequate bone marrow function: anc > 1,000/mm3; platelets > 75,000/mm3
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
INR | Anticoagulation Therapy
Item
inr < 1.5 for those who are not on anticoagulation
boolean
C0525032 (UMLS CUI [1])
C0003281 (UMLS CUI [2])
Prior Chemotherapy Quantity Liver carcinoma
Item
up to two prior chemotherapy regimens for hepatocellular carcinoma
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of > 12 weeks
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CNS metastases apparent Clinical | Meningeal Carcinomatosis
Item
clinically apparent central nervous system metastases or carcinomatous meningitis
boolean
C0686377 (UMLS CUI [1,1])
C0750489 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0220654 (UMLS CUI [2])
Illness Serious Uncontrolled | Mental disorders
Item
uncontrolled serious medical or psychiatric illness
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
current or recent (within 4 weeks of first study infusion) participation in experimental study drug
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Proteinuria Significant
Item
significant proteinuria
boolean
C0033687 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Non-healed wound Serious | Ulcer | Fracture
Item
serious, non-healing wound, ulcer, or bone fracture
boolean
C0750433 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0041582 (UMLS CUI [2])
C0016658 (UMLS CUI [3])
Bleeding tendency Evidence of | Blood Coagulation Disorders Evidence of
Item
evidence of bleeding diathesis or coagulopathy
boolean
C1458140 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0005779 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
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