ID

12999

Beschreibung

Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin Plus Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00695201

Link

https://clinicaltrials.gov/show/NCT00695201

Stichworte

  1. 10.01.16 10.01.16 -
Hochgeladen am

10. Januar 2016

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Colon Cancer NCT00695201

Eligibility Colon Cancer NCT00695201

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease.
Beschreibung

histology

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C1319315
UMLS CUI [1,3]
C0494165
confirmation of diagnosis must be performed at mskcc.
Beschreibung

diagnosis confirmation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0750484
patient's liver metastases must be deemed unresectable and comprise <70% of the liver parenchyma.
Beschreibung

liver metastases

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0494165
UMLS CUI [1,2]
C1519810
UMLS CUI [2]
C0736268
a patient may have had prior chemotherapy or be previously untreated.
Beschreibung

chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
patient may not have received prior treatment with fudr or >2 doses of oxaliplatin.
Beschreibung

floxuridine oxaliplatin

Datentyp

boolean

Alias
UMLS CUI [1]
C0069717
UMLS CUI [2]
C0016343
kps > or = to 60%.
Beschreibung

kps

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
wbc > or = to 3,000 cells/mm3 and platelet count > or = to 100,000 cells/mm3 within 14 days of registration.
Beschreibung

wbc, platelet count

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
creatinine < or = to 1.5 mg/dl within 14 days of registration.
Beschreibung

creatinine

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
total serum bilirubin < or = 2.0 mg/dl within 14 days of registration.
Beschreibung

bilirubin

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
no active concurrent malignancies: except a patient's potentially resectable colorectal primary.
Beschreibung

malignancies

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
patient must not have obstruction of gi or gu tract.
Beschreibung

obstruction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0028778
UMLS CUI [1,2]
C0042066
UMLS CUI [2,1]
C0028778
UMLS CUI [2,2]
C0017189
patient must not have current, symptomatic peripheral sensory neuropathy.
Beschreibung

peripheral sensory neuropathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0151313
no prior radiation to liver.
Beschreibung

radiotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0948510
no active infection, ascites, or hepatic encephalopathy.
Beschreibung

comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
age ≥ 18 years.
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
female patients cannot be pregnant or lactating.
Beschreibung

pregnancy, lactation

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
signed informed consent.
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430

Ähnliche Modelle

Eligibility Colon Cancer NCT00695201

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
histology
Item
history of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease.
boolean
C0019638 (UMLS CUI [1,1])
C1319315 (UMLS CUI [1,2])
C0494165 (UMLS CUI [1,3])
diagnosis confirmation
Item
confirmation of diagnosis must be performed at mskcc.
boolean
C0011900 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
liver metastases
Item
patient's liver metastases must be deemed unresectable and comprise <70% of the liver parenchyma.
boolean
C0494165 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0736268 (UMLS CUI [2])
chemotherapy
Item
a patient may have had prior chemotherapy or be previously untreated.
boolean
C0392920 (UMLS CUI [1])
floxuridine oxaliplatin
Item
patient may not have received prior treatment with fudr or >2 doses of oxaliplatin.
boolean
C0069717 (UMLS CUI [1])
C0016343 (UMLS CUI [2])
kps
Item
kps > or = to 60%.
boolean
C0206065 (UMLS CUI [1])
wbc, platelet count
Item
wbc > or = to 3,000 cells/mm3 and platelet count > or = to 100,000 cells/mm3 within 14 days of registration.
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
creatinine
Item
creatinine < or = to 1.5 mg/dl within 14 days of registration.
boolean
C0201976 (UMLS CUI [1])
bilirubin
Item
total serum bilirubin < or = 2.0 mg/dl within 14 days of registration.
boolean
C1278039 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
malignancies
Item
no active concurrent malignancies: except a patient's potentially resectable colorectal primary.
boolean
C0006826 (UMLS CUI [1])
obstruction
Item
patient must not have obstruction of gi or gu tract.
boolean
C0028778 (UMLS CUI [1,1])
C0042066 (UMLS CUI [1,2])
C0028778 (UMLS CUI [2,1])
C0017189 (UMLS CUI [2,2])
peripheral sensory neuropathy
Item
patient must not have current, symptomatic peripheral sensory neuropathy.
boolean
C0151313 (UMLS CUI [1])
radiotherapy
Item
no prior radiation to liver.
boolean
C0948510 (UMLS CUI [1])
comorbidity
Item
no active infection, ascites, or hepatic encephalopathy.
boolean
C0009488 (UMLS CUI [1])
age
Item
age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
pregnancy, lactation
Item
female patients cannot be pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
informed consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])

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