ID

16776

Description

Combination Chemotherapy as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00303771

Link

https://clinicaltrials.gov/show/NCT00303771

Keywords

Versions (1)
  1. 8/6/16 8/6/16 -
Uploaded on

August 6, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00303771

English

Eligibility Colorectal Cancer NCT00303771

1 forms  
Criteria
Description

Criteria

histologically confirmed adenocarcinoma of the colon or rectum
Description

Adenocarcinoma of colon | Adenocarcinoma of rectum

Data type

boolean

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

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
unresectable disease
Description

Unresectable Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C1336869
measurable disease that is outside the field of prior irradiation
Description

Measurable Disease | irradiation of single field

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C2169158
no brain metastases
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
patient characteristics:
Description

Patient Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
karnofsky performance status 60-100%
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
absolute neutrophil count ≥ 1,500/mm^3
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count ≥ 100,000/mm^3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
transaminases ≤ 5 times normal
Description

Transaminases

Data type

boolean

Alias
UMLS CUI [1]
C0002594
bilirubin ≤ 1.5 times normal
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
alkaline phosphatase < 3 times normal (5 times normal if due to hepatic involvement)
Description

Alkaline phosphatase measurement | Alkaline phosphatase measurement Due to Hepatic Involvement

Data type

boolean

Alias
UMLS CUI [1]
C0201850
UMLS CUI [2,1]
C0201850
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0441932
creatinine clearance > 45 ml/min
Description

Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
life expectancy > 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
no psychological, social, or geographical situation that would preclude study treatment
Description

Condition Exclusion Investigational Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C0949266
no chronic diarrhea or enteropathy
Description

Chronic diarrhea | Intestinal Disease chronic

Data type

boolean

Alias
UMLS CUI [1]
C0401151
UMLS CUI [2,1]
C0021831
UMLS CUI [2,2]
C0205191
no coronary insufficiency or symptomatic cardiac disease
Description

Coronary artery insufficiency | Heart Disease Symptomatic

Data type

boolean

Alias
UMLS CUI [1]
C0542052
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0231220
no other malignancy unless curatively treated
Description

Malignant Neoplasm | curative treatment Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1273390
UMLS CUI [2,2]
C0006826
no contraindication to chemotherapy
Description

Medical contraindication Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0392920
prior concurrent therapy:
Description

Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
at least 6 months since prior adjuvant chemotherapy for the primary tumor
Description

Adjuvant Chemotherapy primary tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0677930
no prior extensive resection
Description

Excision Extensive

Data type

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C0205231
no other concurrent anticancer therapy
Description

cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
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Similar models

Eligibility Colorectal Cancer NCT00303771

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adenocarcinoma of colon | Adenocarcinoma of rectum
Item
histologically confirmed adenocarcinoma of the colon or rectum
boolean
C0338106 (UMLS CUI [1])
C0149978 (UMLS CUI [2])
Neoplasm Metastasis
Item
metastatic disease
boolean
C0027627 (UMLS CUI [1])
Unresectable Malignant Neoplasm
Item
unresectable disease
boolean
C1336869 (UMLS CUI [1])
Measurable Disease | irradiation of single field
Item
measurable disease that is outside the field of prior irradiation
boolean
C1513041 (UMLS CUI [1])
C2169158 (UMLS CUI [2])
Metastatic malignant neoplasm to brain
Item
no brain metastases
boolean
C0220650 (UMLS CUI [1])
Patient Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance status 60-100%
boolean
C0206065 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count ≥ 1,500/mm^3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100,000/mm^3
boolean
C0032181 (UMLS CUI [1])
Transaminases
Item
transaminases ≤ 5 times normal
boolean
C0002594 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin ≤ 1.5 times normal
boolean
C1278039 (UMLS CUI [1])
Alkaline phosphatase measurement | Alkaline phosphatase measurement Due to Hepatic Involvement
Item
alkaline phosphatase < 3 times normal (5 times normal if due to hepatic involvement)
boolean
C0201850 (UMLS CUI [1])
C0201850 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0441932 (UMLS CUI [2,3])
Creatinine clearance measurement
Item
creatinine clearance > 45 ml/min
boolean
C0373595 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Condition Exclusion Investigational Therapy
Item
no psychological, social, or geographical situation that would preclude study treatment
boolean
C0348080 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0949266 (UMLS CUI [1,3])
Chronic diarrhea | Intestinal Disease chronic
Item
no chronic diarrhea or enteropathy
boolean
C0401151 (UMLS CUI [1])
C0021831 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Coronary artery insufficiency | Heart Disease Symptomatic
Item
no coronary insufficiency or symptomatic cardiac disease
boolean
C0542052 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Malignant Neoplasm | curative treatment Malignant Neoplasm
Item
no other malignancy unless curatively treated
boolean
C0006826 (UMLS CUI [1])
C1273390 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
Medical contraindication Chemotherapy
Item
no contraindication to chemotherapy
boolean
C1301624 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
Adjuvant Chemotherapy primary tumor
Item
at least 6 months since prior adjuvant chemotherapy for the primary tumor
boolean
C0085533 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
Excision Extensive
Item
no prior extensive resection
boolean
C0728940 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
cancer treatment
Item
no other concurrent anticancer therapy
boolean
C0920425 (UMLS CUI [1])
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