ID

20201

Description

Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC; ODM derived from: https://clinicaltrials.gov/show/NCT00469443

Link

https://clinicaltrials.gov/show/NCT00469443

Keywords

Versions (1)
  1. 2/12/17 2/12/17 -
Uploaded on

February 12, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00469443

English

Eligibility Colorectal Cancer NCT00469443

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed locally advanced or metastatic colorectal cancer
Description

Colorectal Carcinoma Advanced Local | Colorectal cancer metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
UMLS CUI [2]
C0948380
measurable or evaluable disease
Description

Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
ecog performance status ≤ 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
age 18 - 72 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
adequate liver (bilirubin ≤ 1.5 unl, sgot/sgpt ≤ 4 unl, alp ≤ 2.5 unl), renal (creatinine ≤ 1.5 unl) and bone marrow (anc ≥ 1,500/mm3, plt ≥ 100,000/mm3) function
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Renal function | Creatinine measurement, serum | Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201850
UMLS CUI [6]
C0232804
UMLS CUI [7]
C0201976
UMLS CUI [8,1]
C0005953
UMLS CUI [8,2]
C0031843
UMLS CUI [9]
C0948762
UMLS CUI [10]
C0032181
patients with history of hemoptysis or with increased risk of thromboembolic events should be observed carefully due to administration of avastin
Description

Hemoptysis | Thromboembolism Risk Increased | Avastin Administration Observation

Data type

boolean

Alias
UMLS CUI [1]
C0019079
UMLS CUI [2,1]
C0040038
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0205217
UMLS CUI [3,1]
C1135130
UMLS CUI [3,2]
C1533734
UMLS CUI [3,3]
C0700325
patients must be able to understand the nature of this study
Description

Comprehension Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous 1st line chemotherapy
Description

First line Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0392920
adjuvant chemotherapy with irinotecan regimen with relapse < 6 months after the completion
Description

Irinotecan Adjuvant Chemotherapy | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0123931
UMLS CUI [1,2]
C0085533
UMLS CUI [2]
C0277556
active infection
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
history of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
Description

Heart Disease Serious | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0085612
previous radiotherapy within the last 4 weeks or > 25% of bone marrow
Description

Therapeutic radiology procedure | Therapeutic radiology procedure Bone Marrow Percentage

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0005953
UMLS CUI [2,3]
C0439165
patients with unstable cns metastases
Description

CNS metastases Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0443343
patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction
Description

Chronic diarrhea | Partial bowel obstruction

Data type

boolean

Alias
UMLS CUI [1]
C0401151
UMLS CUI [2]
C1328480
second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
Description

Second Primary Cancers | Skin carcinoma | Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
psychiatric illness or social situation that would preclude study compliance
Description

Mental disorder Protocol Compliance Exclusion | Social situation Protocol Compliance Exclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C2828389
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients > 65 years with history of arterial thromboembolic, myocardial infarction, unstable angina and pulmonary embolism
Description

Age | Arterial thromboembolism | Myocardial Infarction | Angina, Unstable | Pulmonary Embolism

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C3544094
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0034065
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Similar models

Eligibility Colorectal Cancer NCT00469443

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma Advanced Local | Colorectal cancer metastatic
Item
histologically confirmed locally advanced or metastatic colorectal cancer
boolean
C0009402 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0948380 (UMLS CUI [2])
Measurable Disease | Evaluable Disease
Item
measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Age
Item
age 18 - 72 years
boolean
C0001779 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Renal function | Creatinine measurement, serum | Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
adequate liver (bilirubin ≤ 1.5 unl, sgot/sgpt ≤ 4 unl, alp ≤ 2.5 unl), renal (creatinine ≤ 1.5 unl) and bone marrow (anc ≥ 1,500/mm3, plt ≥ 100,000/mm3) function
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
C0232804 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C0005953 (UMLS CUI [8,1])
C0031843 (UMLS CUI [8,2])
C0948762 (UMLS CUI [9])
C0032181 (UMLS CUI [10])
Hemoptysis | Thromboembolism Risk Increased | Avastin Administration Observation
Item
patients with history of hemoptysis or with increased risk of thromboembolic events should be observed carefully due to administration of avastin
boolean
C0019079 (UMLS CUI [1])
C0040038 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0205217 (UMLS CUI [2,3])
C1135130 (UMLS CUI [3,1])
C1533734 (UMLS CUI [3,2])
C0700325 (UMLS CUI [3,3])
Comprehension Study Protocol
Item
patients must be able to understand the nature of this study
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
First line Chemotherapy
Item
previous 1st line chemotherapy
boolean
C1708063 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Irinotecan Adjuvant Chemotherapy | Recurrent disease
Item
adjuvant chemotherapy with irinotecan regimen with relapse < 6 months after the completion
boolean
C0123931 (UMLS CUI [1,1])
C0085533 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2])
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Heart Disease Serious | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia
Item
history of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0085612 (UMLS CUI [5])
Therapeutic radiology procedure | Therapeutic radiology procedure Bone Marrow Percentage
Item
previous radiotherapy within the last 4 weeks or > 25% of bone marrow
boolean
C1522449 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0005953 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
CNS metastases Unstable
Item
patients with unstable cns metastases
boolean
C0686377 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Chronic diarrhea | Partial bowel obstruction
Item
patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction
boolean
C0401151 (UMLS CUI [1])
C1328480 (UMLS CUI [2])
Second Primary Cancers | Skin carcinoma | Carcinoma in situ of uterine cervix
Item
second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
boolean
C0751623 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Mental disorder Protocol Compliance Exclusion | Social situation Protocol Compliance Exclusion
Item
psychiatric illness or social situation that would preclude study compliance
boolean
C0004936 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Age | Arterial thromboembolism | Myocardial Infarction | Angina, Unstable | Pulmonary Embolism
Item
patients > 65 years with history of arterial thromboembolic, myocardial infarction, unstable angina and pulmonary embolism
boolean
C0001779 (UMLS CUI [1])
C3544094 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0034065 (UMLS CUI [5])
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