ID

22014

Description

IRIS Followed by mFOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00316745

Link

https://clinicaltrials.gov/show/NCT00316745

Keywords

Versions (1)
  1. 5/14/17 5/14/17 -
Uploaded on

May 14, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT00316745

English

Eligibility Metastatic Colorectal Cancer NCT00316745

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1) histological diagnosis of colorectal cancer.
Description

colorectal cancer

Data type

boolean

Alias
UMLS CUI [1]
C0009402
2） age: 18 - 75 years.
Description

age

Data type

text

Alias
UMLS CUI [1]
C0001779
3） no prior chemotherapy
Description

prior chemotherapy

Data type

text

Alias
UMLS CUI [1]
C1514457
4） ecog performance status 0 to 2
Description

ecog

Data type

text

Alias
UMLS CUI [1]
C1520224
5) a life expectancy of at least 3 months
Description

life expectancy

Data type

text

Alias
UMLS CUI [1]
C0023671
6) adequate function of major organs (bone marrow, heart, lungs, liver etc.). wbc ≧3,500/mm3 and neutrophil ≧2,000/mm3. hb ≧10.0 g/dl. platelet count ≧100,000/mm3. ast and alt ≦2.5 times the upper limit of normal (excluding liver metastasis). t-bil ≦1.5 mg/dl. creatinine ≦1.5 mg/ dl.
Description

organ function, hematologic, hepatic, renal function

Data type

text

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0221130
UMLS CUI [2,2]
C0023508
UMLS CUI [2,3]
C0948762
UMLS CUI [2,4]
C0019046
UMLS CUI [2,5]
C0005821
UMLS CUI [3,1]
C0232741
UMLS CUI [3,2]
C1278039
UMLS CUI [3,3]
C0201899
UMLS CUI [3,4]
C0201836
UMLS CUI [4,1]
C0232804
UMLS CUI [4,2]
C0201976
7) patients must have the ability to understand and the willingness to sign a written informed contact document.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients receiving blood transfusion, blood derivatives or granulocyte-colony stimulating factor within 7days prior to entering the study.
Description

blood products, granulocyte colony stimulating factor

Data type

boolean

Alias
UMLS CUI [1]
C0456388
UMLS CUI [2]
C0079459
2. patients can not have oral intake
Description

oral intake

Data type

boolean

Alias
UMLS CUI [1]
C0518037
3. patients receiving flucytosine treatment
Description

flucytosine

Data type

boolean

Alias
UMLS CUI [1]
C0016278
4. patients with severe pleural effusion or ascites.
Description

pleural effusion, ascites

Data type

boolean

Alias
UMLS CUI [1]
C0032227
UMLS CUI [2]
C0003962
5. patients who have brown brain metastasis
Description

brain metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0220650
6. patients with diarrhea 4 or more times per day
Description

diarrhea

Data type

boolean

Alias
UMLS CUI [1]
C0011991
7. patients with active gastrointestinal bleeding.
Description

gastrointestinal bleeding

Data type

boolean

Alias
UMLS CUI [1]
C0017181
8. patients with intestinal obstruction
Description

intestinal obstruction

Data type

boolean

Alias
UMLS CUI [1]
C0021843
9. patients with active infection.
Description

active infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
10. patients with serious pulmonary disease (such as interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema)
Description

pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C0024115
11. patients with serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
Description

serious complications

Data type

boolean

Alias
UMLS CUI [1]
C0009566
12. patients with significant cardiac disease.
Description

cardiac disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
13. patients with active multiple cancer.
Description

multiple cancer

Data type

boolean

Alias
UMLS CUI [1]
C0346429
14. patients with neuropathy ≥ grade 2
Description

neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0442874
15. patients who are pregnant, are of childbearing potential, or breast-feeding.
Description

pregnancy, childbearing potential, breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0006147
16. patients with severe mental disorder.
Description

mental disorder

Data type

boolean

Alias
UMLS CUI [1]
C0004936
17. patients with a history of serious allergic reaction.
Description

allergic reaction

Data type

boolean

Alias
UMLS CUI [1]
C1527304
18. judged to be ineligible for this protocol by the investigation.
Description

ineligibility by investigation

Data type

boolean

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C1512714
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Similar models

Eligibility Metastatic Colorectal Cancer NCT00316745

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
colorectal cancer
Item
1) histological diagnosis of colorectal cancer.
boolean
C0009402 (UMLS CUI [1])
age
Item
2） age: 18 - 75 years.
text
C0001779 (UMLS CUI [1])
prior chemotherapy
Item
3） no prior chemotherapy
text
C1514457 (UMLS CUI [1])
ecog
Item
4） ecog performance status 0 to 2
text
C1520224 (UMLS CUI [1])
life expectancy
Item
5) a life expectancy of at least 3 months
text
C0023671 (UMLS CUI [1])
organ function, hematologic, hepatic, renal function
Item
6) adequate function of major organs (bone marrow, heart, lungs, liver etc.). wbc ≧3,500/mm3 and neutrophil ≧2,000/mm3. hb ≧10.0 g/dl. platelet count ≧100,000/mm3. ast and alt ≦2.5 times the upper limit of normal (excluding liver metastasis). t-bil ≦1.5 mg/dl. creatinine ≦1.5 mg/ dl.
text
C0678852 (UMLS CUI [1])
C0221130 (UMLS CUI [2,1])
C0023508 (UMLS CUI [2,2])
C0948762 (UMLS CUI [2,3])
C0019046 (UMLS CUI [2,4])
C0005821 (UMLS CUI [2,5])
C0232741 (UMLS CUI [3,1])
C1278039 (UMLS CUI [3,2])
C0201899 (UMLS CUI [3,3])
C0201836 (UMLS CUI [3,4])
C0232804 (UMLS CUI [4,1])
C0201976 (UMLS CUI [4,2])
informed consent
Item
7) patients must have the ability to understand and the willingness to sign a written informed contact document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
blood products, granulocyte colony stimulating factor
Item
1. patients receiving blood transfusion, blood derivatives or granulocyte-colony stimulating factor within 7days prior to entering the study.
boolean
C0456388 (UMLS CUI [1])
C0079459 (UMLS CUI [2])
oral intake
Item
2. patients can not have oral intake
boolean
C0518037 (UMLS CUI [1])
flucytosine
Item
3. patients receiving flucytosine treatment
boolean
C0016278 (UMLS CUI [1])
pleural effusion, ascites
Item
4. patients with severe pleural effusion or ascites.
boolean
C0032227 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
brain metastasis
Item
5. patients who have brown brain metastasis
boolean
C0220650 (UMLS CUI [1])
diarrhea
Item
6. patients with diarrhea 4 or more times per day
boolean
C0011991 (UMLS CUI [1])
gastrointestinal bleeding
Item
7. patients with active gastrointestinal bleeding.
boolean
C0017181 (UMLS CUI [1])
intestinal obstruction
Item
8. patients with intestinal obstruction
boolean
C0021843 (UMLS CUI [1])
active infection
Item
9. patients with active infection.
boolean
C0009450 (UMLS CUI [1])
pulmonary disease
Item
10. patients with serious pulmonary disease (such as interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema)
boolean
C0024115 (UMLS CUI [1])
serious complications
Item
11. patients with serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
boolean
C0009566 (UMLS CUI [1])
cardiac disease
Item
12. patients with significant cardiac disease.
boolean
C0018799 (UMLS CUI [1])
multiple cancer
Item
13. patients with active multiple cancer.
boolean
C0346429 (UMLS CUI [1])
neuropathy
Item
14. patients with neuropathy ≥ grade 2
boolean
C0442874 (UMLS CUI [1])
pregnancy, childbearing potential, breast feeding
Item
15. patients who are pregnant, are of childbearing potential, or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
mental disorder
Item
16. patients with severe mental disorder.
boolean
C0004936 (UMLS CUI [1])
allergic reaction
Item
17. patients with a history of serious allergic reaction.
boolean
C1527304 (UMLS CUI [1])
ineligibility by investigation
Item
18. judged to be ineligible for this protocol by the investigation.
boolean
C0220825 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
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