ID

16741

Description

Study of Cetuximab, Oxaliplatin, 5-FU/LV Versus Oxaliplatin, 5-FU/LV in Patients With Previously Treated Metastatic, EGFR-Positive Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00061815

Link

https://clinicaltrials.gov/show/NCT00061815

Keywords

Versions (1)
  1. 8/3/16 8/3/16 -
Uploaded on

August 3, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00061815

English

Eligibility Colorectal Cancer NCT00061815

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented colorectal cancer which is egfr-positive and is metastatic.
Description

Colorectal cancer metastatic Epidermal Growth Factor Receptor Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0948380
UMLS CUI [1,2]
C0034802
UMLS CUI [1,3]
C1446409
prior irinotecan, alone or in combination, as first-line treatment of metastatic disease.
Description

irinotecan | First line treatment Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0123931
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0027627
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a serious uncontrolled medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive protocol therapy.
Description

Disease Uncontrolled Serious Impairing Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0205404
UMLS CUI [1,4]
C0221099
UMLS CUI [1,5]
C0525058
known dihydropyrimidine dehydrogenase (dpd) deficiency.
Description

Dihydropyrimidine Dehydrogenase Deficiency

Data type

boolean

Alias
UMLS CUI [1]
C1959620
known metastases in the central nervous system.
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
symptomatic sensory or peripheral neuropathy.
Description

Sensory neuropathy Symptomatic | Peripheral Neuropathy Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0151313
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0031117
UMLS CUI [2,2]
C0231220
more than one prior chemotherapy regimen for the treatment of metastatic colorectal cancer.
Description

Prior Chemotherapy Quantity Colorectal cancer metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0948380
prior oxaliplatin therapy.
Description

oxaliplatin

Data type

boolean

Alias
UMLS CUI [1]
C0069717
prior cetuximab or other therapy which targets the egf pathway.
Description

cetuximab Targeting Epidermal Growth Factor Receptor Pathway | Therapeutic procedure Targeting Epidermal Growth Factor Receptor Pathway

Data type

boolean

Alias
UMLS CUI [1,1]
C0995188
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C2984382
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C2984382
prior chimerized or murine monoclonal antibody therapy.
Description

Monoclonal Antibody Therapy chimeric | Monoclonal Antibody Therapy Murine

Data type

boolean

Alias
UMLS CUI [1,1]
C0279694
UMLS CUI [1,2]
C0598622
UMLS CUI [2,1]
C0279694
UMLS CUI [2,2]
C0026809
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Similar models

Eligibility Colorectal Cancer NCT00061815

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal cancer metastatic Epidermal Growth Factor Receptor Positive
Item
documented colorectal cancer which is egfr-positive and is metastatic.
boolean
C0948380 (UMLS CUI [1,1])
C0034802 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
irinotecan | First line treatment Neoplasm Metastasis
Item
prior irinotecan, alone or in combination, as first-line treatment of metastatic disease.
boolean
C0123931 (UMLS CUI [1])
C1708063 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Disease Uncontrolled Serious Impairing Protocol Compliance
Item
a serious uncontrolled medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive protocol therapy.
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0221099 (UMLS CUI [1,4])
C0525058 (UMLS CUI [1,5])
Dihydropyrimidine Dehydrogenase Deficiency
Item
known dihydropyrimidine dehydrogenase (dpd) deficiency.
boolean
C1959620 (UMLS CUI [1])
CNS metastases
Item
known metastases in the central nervous system.
boolean
C0686377 (UMLS CUI [1])
Sensory neuropathy Symptomatic | Peripheral Neuropathy Symptomatic
Item
symptomatic sensory or peripheral neuropathy.
boolean
C0151313 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0031117 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Prior Chemotherapy Quantity Colorectal cancer metastatic
Item
more than one prior chemotherapy regimen for the treatment of metastatic colorectal cancer.
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0948380 (UMLS CUI [1,3])
oxaliplatin
Item
prior oxaliplatin therapy.
boolean
C0069717 (UMLS CUI [1])
cetuximab Targeting Epidermal Growth Factor Receptor Pathway | Therapeutic procedure Targeting Epidermal Growth Factor Receptor Pathway
Item
prior cetuximab or other therapy which targets the egf pathway.
boolean
C0995188 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C2984382 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C2984382 (UMLS CUI [2,3])
Monoclonal Antibody Therapy chimeric | Monoclonal Antibody Therapy Murine
Item
prior chimerized or murine monoclonal antibody therapy.
boolean
C0279694 (UMLS CUI [1,1])
C0598622 (UMLS CUI [1,2])
C0279694 (UMLS CUI [2,1])
C0026809 (UMLS CUI [2,2])
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