ID

15300

Description

FOLFOXIRI Compared With FOLFIRI for Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01219920

Link

https://clinicaltrials.gov/show/NCT01219920

Keywords

Versions (1)
  1. 5/25/16 5/25/16 -
Uploaded on

May 25, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT01219920

English

Eligibility Metastatic Colorectal Cancer NCT01219920

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adenocarcinoma of the colon or rectum
Description

adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0338106
UMLS CUI [2]
C0149978
unresectable metastatic disease
Description

metastatic disease

Data type

boolean

Alias
UMLS CUI [1]
C0027627
age 18 to 75 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status of 2 or lower if age 70 years or younger or ecog performance status of 0 if age 71 to 75 years measurable disease according to whocriteria
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
leukocyte count of at least 3,500/mm3, neutrophils count of at least 1,500/mm3, platelet count of at least 100,000/mm3
Description

leukocyte count

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0005821
serum creatinine of 1.3 mg/dl or less
Description

serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
serum bilirubin less than 1.5 mg/dl and ast, alt, and alkaline phosphatase 2.5 x normal values or less (</= 5 if liver metastases)
Description

serum bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201850
previous fluoropyrimidine-based adjuvant chemotherapy was allowed if ended more than 6 months before random assignment
Description

fluoropyrimidine-based adjuvant chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0596581
UMLS CUI [1,2]
C0392920
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous palliative chemotherapy for metastatic disease
Description

palliative chemotherapy for metastatic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1285530
UMLS CUI [1,3]
C0027627
previous chemotherapy including irinotecan or oxaliplatin
Description

previous chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
symptomatic cardiac disease, myocardial infarction in the last 24 months or uncontrolled arrhythmia
Description

cardiac disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0205318
active infections
Description

Active infections

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C3714514
inflammatory bowel disease
Description

inflammatory bowel disease

Data type

boolean

Alias
UMLS CUI [1]
C0021390
total colectomy
Description

total colectomy

Data type

boolean

Alias
UMLS CUI [1]
C0192871
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Similar models

Eligibility Metastatic Colorectal Cancer NCT01219920

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
adenocarcinoma
Item
adenocarcinoma of the colon or rectum
boolean
C0338106 (UMLS CUI [1])
C0149978 (UMLS CUI [2])
metastatic disease
Item
unresectable metastatic disease
boolean
C0027627 (UMLS CUI [1])
age
Item
age 18 to 75 years
boolean
C0001779 (UMLS CUI [1])
ecog performance status
Item
eastern cooperative oncology group (ecog) performance status of 2 or lower if age 70 years or younger or ecog performance status of 0 if age 71 to 75 years measurable disease according to whocriteria
boolean
C1520224 (UMLS CUI [1])
leukocyte count
Item
leukocyte count of at least 3,500/mm3, neutrophils count of at least 1,500/mm3, platelet count of at least 100,000/mm3
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
serum creatinine
Item
serum creatinine of 1.3 mg/dl or less
boolean
C0201976 (UMLS CUI [1])
serum bilirubin
Item
serum bilirubin less than 1.5 mg/dl and ast, alt, and alkaline phosphatase 2.5 x normal values or less (</= 5 if liver metastases)
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
fluoropyrimidine-based adjuvant chemotherapy
Item
previous fluoropyrimidine-based adjuvant chemotherapy was allowed if ended more than 6 months before random assignment
boolean
C0596581 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
palliative chemotherapy for metastatic disease
Item
previous palliative chemotherapy for metastatic disease
boolean
C0392920 (UMLS CUI [1,1])
C1285530 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
previous chemotherapy
Item
previous chemotherapy including irinotecan or oxaliplatin
boolean
C0392920 (UMLS CUI [1])
cardiac disease
Item
symptomatic cardiac disease, myocardial infarction in the last 24 months or uncontrolled arrhythmia
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Active infections
Item
active infections
boolean
C0009488 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
inflammatory bowel disease
Item
inflammatory bowel disease
boolean
C0021390 (UMLS CUI [1])
total colectomy
Item
total colectomy
boolean
C0192871 (UMLS CUI [1])
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