ID

15758

Description

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

Link

https://clinicaltrials.gov/show/NCT00126256

Keywords

Versions (1)
  1. 6/11/16 6/11/16 -
Uploaded on

June 11, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00126256

English

Eligibility Colorectal Cancer NCT00126256

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed metastatic colorectal adenocarcinoma
Description

metastatic colorectal adenocarcinoma

Data type

boolean

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

unresectable metastasis

Data type

boolean

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

bidimensionally measurable disease

Data type

boolean

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

WHO performance status

Data type

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)
Description

hematologic functions

Data type

boolean

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

renal function

Data type

boolean

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

liver function

Data type

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
Description

no previous chemotherapy

Data type

boolean

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

written inform consent

Data type

boolean

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

quality of life questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C0518214
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast – feeding women
Description

pregnancy or breast-feeding

Data type

boolean

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

impossibility of regular follow-up

Data type

boolean

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

severe organ failure

Data type

boolean

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

coronary heart disease

Data type

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
Description

psychological illness

Data type

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
Description

CNS metastases

Data type

boolean

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

history of second malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
another investigational drug
Description

another investigational drug

Data type

boolean

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

chronic inflammatory bowel disease

Data type

boolean

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

chemotherapy with irinotecan or oxaliplatin

Data type

boolean

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

Eligibility Colorectal Cancer NCT00126256

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