ID

20997

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00351195

Trefwoorden

Versies (1)
  1. 02-04-17 02-04-17 -
Geüploaded op

2 april 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Hepatocellular Carcinoma NCT00351195

Engels

Eligibility Hepatocellular Carcinoma NCT00351195

1 Formulieren  
Inclusion Criteria
Beschrijving

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
Beschrijving

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

Datatype

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
Beschrijving

performance status

Datatype

boolean

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

Age

Datatype

boolean

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

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
normal bone marrow function (neutrophiles > 1,5 x 109/l and platelets > 100 x 109/l)
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
bilirubin < 2 x unl
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

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

Transaminases

Datatype

boolean

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

Renal function | EDTA Clearance

Datatype

boolean

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

Chemotherapy Absent | Therapeutic radiology procedure Absent | Immunotherapy Absent

Datatype

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
Beschrijving

Comorbidity Severe Uncontrolled Absent

Datatype

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
Beschrijving

Childbearing Potential Pregnancy test negative

Datatype

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
Beschrijving

Childbearing Potential Contraceptive methods

Datatype

boolean

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

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Chemotherapy | Therapeutic radiology procedure | Immunotherapy

Datatype

boolean

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

Therapy, Investigational

Datatype

boolean

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

Dihydropyrimidine Dehydrogenase Deficiency

Datatype

boolean

Alias
UMLS CUI [1]
C1959620
known neuropathy
Beschrijving

Neuropathy

Datatype

boolean

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

Comorbidity Severe Uncontrolled

Datatype

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.
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
Terug naar het begin van de pagina

Similar models

Eligibility Hepatocellular Carcinoma NCT00351195

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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