ID

15758

Beschrijving

Trial Comparing Two Strategies of Chemotherapy for Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00126256

Link

https://clinicaltrials.gov/show/NCT00126256

Trefwoorden

  1. 11-06-16 11-06-16 -
Geüploaded op

11 juni 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Colorectal Cancer NCT00126256

Eligibility Colorectal Cancer NCT00126256

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed metastatic colorectal adenocarcinoma
Beschrijving

metastatic colorectal adenocarcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319315
UMLS CUI [1,2]
C0027627
unresectable metastasis
Beschrijving

unresectable metastasis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1519810
bidimensionally measurable disease (world health organization [who] criteria)
Beschrijving

bidimensionally measurable disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
who performance status of 2 or less
Beschrijving

WHO performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
adequate hematologic functions (neutrophil count, at least 1500 per cubic millimeter; and platelet count, at least 100,000 per cubic millimetre)
Beschrijving

hematologic functions

Datatype

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0005821
adequate renal function (serum creatinine, less than 125 micromol per liter)
Beschrijving

renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
adequate liver function (bilirubin, not more than 5 times the upper limit of normal)
Beschrijving

liver function

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
no previous chemotherapy other than previous adjuvant chemotherapy or concomitant chemoradiotherapy with 5-fluorouracil and leucovorin for the treatment of the primary tumor completed at least 6 months before inclusion
Beschrijving

no previous chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
signed written inform consent
Beschrijving

written inform consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
quality of life questionnaire (qlq c-30) filled out
Beschrijving

quality of life questionnaire

Datatype

boolean

Alias
UMLS CUI [1]
C0518214
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast – feeding women
Beschrijving

pregnancy or breast-feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
impossibility of regular follow-up for psychological, social or geographical reason
Beschrijving

impossibility of regular follow-up

Datatype

boolean

Alias
UMLS CUI [1,1]
C0814423
UMLS CUI [1,2]
C1522577
severe cardiac, respiratory, renal or hepatic failure
Beschrijving

severe organ failure

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
active coronary heart disease
Beschrijving

coronary heart disease

Datatype

boolean

Alias
UMLS CUI [1]
C0010068
patients with a history of a psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study
Beschrijving

psychological illness

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C0439801
central nervous system metastases
Beschrijving

CNS metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
past history of second malignancies
Beschrijving

history of second malignancies

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
another investigational drug
Beschrijving

another investigational drug

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
chronic inflammatory bowel disease
Beschrijving

chronic inflammatory bowel disease

Datatype

boolean

Alias
UMLS CUI [1]
C1856359
previous chemotherapy with irinotecan or oxaliplatin based regimens
Beschrijving

chemotherapy with irinotecan or oxaliplatin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0123931
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0069717

Similar models

Eligibility Colorectal Cancer NCT00126256

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
metastatic colorectal adenocarcinoma
Item
histologically confirmed metastatic colorectal adenocarcinoma
boolean
C1319315 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
unresectable metastasis
Item
unresectable metastasis
boolean
C0027627 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
bidimensionally measurable disease
Item
bidimensionally measurable disease (world health organization [who] criteria)
boolean
C1513041 (UMLS CUI [1])
WHO performance status
Item
who performance status of 2 or less
boolean
C1298650 (UMLS CUI [1])
hematologic functions
Item
adequate hematologic functions (neutrophil count, at least 1500 per cubic millimeter; and platelet count, at least 100,000 per cubic millimetre)
boolean
C0200633 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
renal function
Item
adequate renal function (serum creatinine, less than 125 micromol per liter)
boolean
C0201976 (UMLS CUI [1])
liver function
Item
adequate liver function (bilirubin, not more than 5 times the upper limit of normal)
boolean
C1278039 (UMLS CUI [1])
no previous chemotherapy
Item
no previous chemotherapy other than previous adjuvant chemotherapy or concomitant chemoradiotherapy with 5-fluorouracil and leucovorin for the treatment of the primary tumor completed at least 6 months before inclusion
boolean
C0392920 (UMLS CUI [1])
written inform consent
Item
signed written inform consent
boolean
C0021430 (UMLS CUI [1])
quality of life questionnaire
Item
quality of life questionnaire (qlq c-30) filled out
boolean
C0518214 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnancy or breast-feeding
Item
pregnant or breast – feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
impossibility of regular follow-up
Item
impossibility of regular follow-up for psychological, social or geographical reason
boolean
C0814423 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
severe organ failure
Item
severe cardiac, respiratory, renal or hepatic failure
boolean
C0009488 (UMLS CUI [1])
coronary heart disease
Item
active coronary heart disease
boolean
C0010068 (UMLS CUI [1])
psychological illness
Item
patients with a history of a psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study
boolean
C0004936 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
CNS metastases
Item
central nervous system metastases
boolean
C0686377 (UMLS CUI [1])
history of second malignancies
Item
past history of second malignancies
boolean
C0006826 (UMLS CUI [1])
another investigational drug
Item
another investigational drug
boolean
C2348568 (UMLS CUI [1])
chronic inflammatory bowel disease
Item
chronic inflammatory bowel disease
boolean
C1856359 (UMLS CUI [1])
chemotherapy with irinotecan or oxaliplatin
Item
previous chemotherapy with irinotecan or oxaliplatin based regimens
boolean
C0392920 (UMLS CUI [1,1])
C0123931 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0069717 (UMLS CUI [2,2])

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