ID

20215

Description

ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00385021

Link

https://clinicaltrials.gov/show/NCT00385021

Keywords

Versions (1)
  1. 2/14/17 2/14/17 -
Uploaded on

February 14, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT00385021

English

Eligibility Colorectal Neoplasms NCT00385021

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological proof of adenocarcinoma in primary colon or rectum tumor.
Description

Primary adenocarcinoma of colon | Adenocarcinoma of rectum Primary

Data type

boolean

Alias
UMLS CUI [1]
C3472669
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C0205225
evidence of metastatic colorectal cancer or loco-regional recurrence or unresectable disease.
Description

Colorectal cancer metastatic Evidence of | Neoplasm Recurrence, Local | Unresectable Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1,1]
C0948380
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0027643
UMLS CUI [3]
C1336869
ages 18 to 86 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
presence of at least one bi-dimensionally measurable disease with at least one diameter > or = 2 cm.
Description

Measurable Disease 2-Dimensional Quantity | Measurable Disease Diameter Size Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0456389
UMLS CUI [2,4]
C1265611
who/ecog performance status < 3 (0, 1, or 2)
Description

WHO performance status scale | ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1298650
UMLS CUI [2]
C1520224
prior treatment with oxaliplatin, 5-fu, or leucovorin permitted.
Description

oxaliplatin | Fluorouracil | Leucovorin

Data type

boolean

Alias
UMLS CUI [1]
C0069717
UMLS CUI [2]
C0016360
UMLS CUI [3]
C0023413
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
peripheral sensory neuropathy > or = grade 3.
Description

Sensory neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0151313
UMLS CUI [1,2]
C1516728
serum bilirubin (total) > 3 x uln.
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
symptomatic or uncontrolled brain metastasis.
Description

Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0205318
metastases limited to bone, pleural effusion, or ascites.
Description

Secondary malignant neoplasm of bone | Pleural effusion | Ascites

Data type

boolean

Alias
UMLS CUI [1]
C0153690
UMLS CUI [2]
C0032227
UMLS CUI [3]
C0003962
uncontrolled overt cardiac disease.
Description

Heart Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
uncontrolled hypercalcemia.
Description

Hypercalcemia Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0020437
UMLS CUI [1,2]
C0205318
uncontrolled infections.
Description

Communicable Diseases Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
uncontrolled hypertension (>180/110)
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
history of gi perforation.
Description

Gastrointestinal perforation

Data type

boolean

Alias
UMLS CUI [1]
C0151664
history of arterial thromboembolic events.
Description

Arterial thromboembolism

Data type

boolean

Alias
UMLS CUI [1]
C3544094
history of congestive heart failure.
Description

Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
patients taking warfarin (coumadin).
Description

Warfarin | Coumadin

Data type

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0699129
patients who are pregnant.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Colorectal Neoplasms NCT00385021

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Primary adenocarcinoma of colon | Adenocarcinoma of rectum Primary
Item
histological proof of adenocarcinoma in primary colon or rectum tumor.
boolean
C3472669 (UMLS CUI [1])
C0149978 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
Colorectal cancer metastatic Evidence of | Neoplasm Recurrence, Local | Unresectable Malignant Neoplasm
Item
evidence of metastatic colorectal cancer or loco-regional recurrence or unresectable disease.
boolean
C0948380 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0027643 (UMLS CUI [2])
C1336869 (UMLS CUI [3])
Age
Item
ages 18 to 86 years.
boolean
C0001779 (UMLS CUI [1])
Measurable Disease 2-Dimensional Quantity | Measurable Disease Diameter Size Quantity
Item
presence of at least one bi-dimensionally measurable disease with at least one diameter > or = 2 cm.
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0456389 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
WHO performance status scale | ECOG performance status
Item
who/ecog performance status < 3 (0, 1, or 2)
boolean
C1298650 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
oxaliplatin | Fluorouracil | Leucovorin
Item
prior treatment with oxaliplatin, 5-fu, or leucovorin permitted.
boolean
C0069717 (UMLS CUI [1])
C0016360 (UMLS CUI [2])
C0023413 (UMLS CUI [3])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Sensory neuropathy CTCAE Grades
Item
peripheral sensory neuropathy > or = grade 3.
boolean
C0151313 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Serum total bilirubin measurement
Item
serum bilirubin (total) > 3 x uln.
boolean
C1278039 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Uncontrolled
Item
symptomatic or uncontrolled brain metastasis.
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Secondary malignant neoplasm of bone | Pleural effusion | Ascites
Item
metastases limited to bone, pleural effusion, or ascites.
boolean
C0153690 (UMLS CUI [1])
C0032227 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
Heart Disease Uncontrolled
Item
uncontrolled overt cardiac disease.
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Hypercalcemia Uncontrolled
Item
uncontrolled hypercalcemia.
boolean
C0020437 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Communicable Diseases Uncontrolled
Item
uncontrolled infections.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Uncontrolled hypertension
Item
uncontrolled hypertension (>180/110)
boolean
C1868885 (UMLS CUI [1])
Gastrointestinal perforation
Item
history of gi perforation.
boolean
C0151664 (UMLS CUI [1])
Arterial thromboembolism
Item
history of arterial thromboembolic events.
boolean
C3544094 (UMLS CUI [1])
Congestive heart failure
Item
history of congestive heart failure.
boolean
C0018802 (UMLS CUI [1])
Warfarin | Coumadin
Item
patients taking warfarin (coumadin).
boolean
C0043031 (UMLS CUI [1])
C0699129 (UMLS CUI [2])
Pregnancy
Item
patients who are pregnant.
boolean
C0032961 (UMLS CUI [1])
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