ID

15300

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01219920

Trefwoorden

  1. 25-05-16 25-05-16 -
Geüploaded op

25 mei 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Metastatic Colorectal Cancer NCT01219920

Eligibility Metastatic Colorectal Cancer NCT01219920

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
adenocarcinoma of the colon or rectum
Beschrijving

adenocarcinoma

Datatype

boolean

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

metastatic disease

Datatype

boolean

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

age

Datatype

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
Beschrijving

ecog performance status

Datatype

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
Beschrijving

leukocyte count

Datatype

boolean

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

serum creatinine

Datatype

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)
Beschrijving

serum bilirubin

Datatype

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
Beschrijving

fluoropyrimidine-based adjuvant chemotherapy

Datatype

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous palliative chemotherapy for metastatic disease
Beschrijving

palliative chemotherapy for metastatic disease

Datatype

boolean

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

previous chemotherapy

Datatype

boolean

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

cardiac disease

Datatype

boolean

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

Active infections

Datatype

boolean

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

inflammatory bowel disease

Datatype

boolean

Alias
UMLS CUI [1]
C0021390
total colectomy
Beschrijving

total colectomy

Datatype

boolean

Alias
UMLS CUI [1]
C0192871

Similar models

Eligibility Metastatic Colorectal Cancer NCT01219920

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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