ID

20997

Description

Etoposide, Oxaliplatin and Capecitabine in Advanced Hepatocellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT00351195

Lien

https://clinicaltrials.gov/show/NCT00351195

Mots-clés

Versions (1)
  1. 02/04/2017 02/04/2017 -
Téléchargé le

2 avril 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00351195

Anglais

Eligibility Hepatocellular Carcinoma NCT00351195

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically verified intra- or extrahepatic inoperable hepatocellular carcinoma or hyperdense liver lesion at computed tomography and concurrent elevated alpha-feto-protein > 400 ng/ml
Description

Liver carcinoma Inoperable intrahepatic | Liver carcinoma Inoperable Extrahepatic | Lesion of liver Dense X-Ray Computed Tomography | Elevated alpha-fetoprotein

Type de données

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205187
UMLS CUI [1,3]
C1512948
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0205187
UMLS CUI [2,3]
C1517058
UMLS CUI [3,1]
C0577053
UMLS CUI [3,2]
C0439794
UMLS CUI [3,3]
C0040405
UMLS CUI [4]
C0235971
ps 0-2
Description

performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1518965
age 18-75
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy > 12 weeks
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
normal bone marrow function (neutrophiles > 1,5 x 109/l and platelets > 100 x 109/l)
Description

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
bilirubin < 2 x unl
Description

Serum total bilirubin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
transaminases < 3 x unl
Description

Transaminases

Type de données

boolean

Alias
UMLS CUI [1]
C0002594
normal renal function, cr-edta clearance > 50 ml/min
Description

Renal function | EDTA Clearance

Type de données

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C3639405
no chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
Description

Chemotherapy Absent | Therapeutic radiology procedure Absent | Immunotherapy Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0332197
no uncontrolled, severe concurrent medical disease
Description

Comorbidity Severe Uncontrolled Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
UMLS CUI [1,4]
C0332197
fertile women must have a negative pregnancy test
Description

Childbearing Potential Pregnancy test negative

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
fertile women must use adequate contraceptives during and 3 months after trial exposure
Description

Childbearing Potential Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
signed informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
Description

Chemotherapy | Therapeutic radiology procedure | Immunotherapy

Type de données

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
experimental therapy < 8 weeks prior to inclusion
Description

Therapy, Investigational

Type de données

boolean

Alias
UMLS CUI [1]
C0949266
known dpd-deficiency
Description

Dihydropyrimidine Dehydrogenase Deficiency

Type de données

boolean

Alias
UMLS CUI [1]
C1959620
known neuropathy
Description

Neuropathy

Type de données

boolean

Alias
UMLS CUI [1]
C0442874
uncontrolled, severe concurrent medical disease
Description

Comorbidity Severe Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
prior malignancy during the last 5 years, except for non-melanoma skin cancer and carcinoma in situ cervix uteri.
Description

Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
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Similar models

Eligibility Hepatocellular Carcinoma NCT00351195

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma Inoperable intrahepatic | Liver carcinoma Inoperable Extrahepatic | Lesion of liver Dense X-Ray Computed Tomography | Elevated alpha-fetoprotein
Item
histologically verified intra- or extrahepatic inoperable hepatocellular carcinoma or hyperdense liver lesion at computed tomography and concurrent elevated alpha-feto-protein > 400 ng/ml
boolean
C2239176 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C1512948 (UMLS CUI [1,3])
C2239176 (UMLS CUI [2,1])
C0205187 (UMLS CUI [2,2])
C1517058 (UMLS CUI [2,3])
C0577053 (UMLS CUI [3,1])
C0439794 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C0235971 (UMLS CUI [4])
performance status
Item
ps 0-2
boolean
C1518965 (UMLS CUI [1])
Age
Item
age 18-75
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 12 weeks
boolean
C0023671 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
normal bone marrow function (neutrophiles > 1,5 x 109/l and platelets > 100 x 109/l)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Serum total bilirubin measurement
Item
bilirubin < 2 x unl
boolean
C1278039 (UMLS CUI [1])
Transaminases
Item
transaminases < 3 x unl
boolean
C0002594 (UMLS CUI [1])
Renal function | EDTA Clearance
Item
normal renal function, cr-edta clearance > 50 ml/min
boolean
C0232804 (UMLS CUI [1])
C3639405 (UMLS CUI [2])
Chemotherapy Absent | Therapeutic radiology procedure Absent | Immunotherapy Absent
Item
no chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Comorbidity Severe Uncontrolled Absent
Item
no uncontrolled, severe concurrent medical disease
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Childbearing Potential Pregnancy test negative
Item
fertile women must have a negative pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods
Item
fertile women must use adequate contraceptives during and 3 months after trial exposure
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure | Immunotherapy
Item
chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
Therapy, Investigational
Item
experimental therapy < 8 weeks prior to inclusion
boolean
C0949266 (UMLS CUI [1])
Dihydropyrimidine Dehydrogenase Deficiency
Item
known dpd-deficiency
boolean
C1959620 (UMLS CUI [1])
Neuropathy
Item
known neuropathy
boolean
C0442874 (UMLS CUI [1])
Comorbidity Severe Uncontrolled
Item
uncontrolled, severe concurrent medical disease
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix
Item
prior malignancy during the last 5 years, except for non-melanoma skin cancer and carcinoma in situ cervix uteri.
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
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