ID

12999

Description

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

Keywords

Versions (1)
  1. 1/10/16 1/10/16 -
Uploaded on

January 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Colon Cancer NCT00695201

English

Eligibility Colon Cancer NCT00695201

1 forms  
Inclusion Criteria
Description

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.
Description

histology

Data type

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.
Description

diagnosis confirmation

Data type

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.
Description

liver metastases

Data type

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.
Description

chemotherapy

Data type

boolean

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

floxuridine oxaliplatin

Data type

boolean

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

kps

Data type

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.
Description

wbc, platelet count

Data type

boolean

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

creatinine

Data type

boolean

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

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
Exclusion Criteria
Description

Exclusion Criteria

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

malignancies

Data type

boolean

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

obstruction

Data type

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.
Description

peripheral sensory neuropathy

Data type

boolean

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

radiotherapy

Data type

boolean

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

comorbidity

Data type

boolean

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

age

Data type

boolean

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

pregnancy, lactation

Data type

boolean

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

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Colon Cancer NCT00695201

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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