ID

20997

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00351195

Stichworte

Versionen (1)
  1. 02.04.17 02.04.17 -
Hochgeladen am

2. April 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Hepatocellular Carcinoma NCT00351195

Englisch

Eligibility Hepatocellular Carcinoma NCT00351195

1 Formulare  
Inclusion Criteria
Beschreibung

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
Beschreibung

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

Datentyp

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
Beschreibung

performance status

Datentyp

boolean

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

Age

Datentyp

boolean

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

Life Expectancy

Datentyp

boolean

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

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Datentyp

boolean

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

Serum total bilirubin measurement

Datentyp

boolean

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

Transaminases

Datentyp

boolean

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

Renal function | EDTA Clearance

Datentyp

boolean

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

Chemotherapy Absent | Therapeutic radiology procedure Absent | Immunotherapy Absent

Datentyp

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
Beschreibung

Comorbidity Severe Uncontrolled Absent

Datentyp

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
Beschreibung

Childbearing Potential Pregnancy test negative

Datentyp

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
Beschreibung

Childbearing Potential Contraceptive methods

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Chemotherapy | Therapeutic radiology procedure | Immunotherapy

Datentyp

boolean

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

Therapy, Investigational

Datentyp

boolean

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

Dihydropyrimidine Dehydrogenase Deficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C1959620
known neuropathy
Beschreibung

Neuropathy

Datentyp

boolean

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

Comorbidity Severe Uncontrolled

Datentyp

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.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Hepatocellular Carcinoma NCT00351195

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video