ID

22014

Beschrijving

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

Trefwoorden

Versies (1)
  1. 14-05-17 14-05-17 -
Geüploaded op

14 mei 2017

DOI

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Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT00316745

Engels

Eligibility Metastatic Colorectal Cancer NCT00316745

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

colorectal cancer

Datatype

boolean

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

age

Datatype

text

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

prior chemotherapy

Datatype

text

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

ecog

Datatype

text

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

life expectancy

Datatype

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.
Beschrijving

organ function, hematologic, hepatic, renal function

Datatype

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.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

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.
Beschrijving

blood products, granulocyte colony stimulating factor

Datatype

boolean

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

oral intake

Datatype

boolean

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

flucytosine

Datatype

boolean

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

pleural effusion, ascites

Datatype

boolean

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

brain metastasis

Datatype

boolean

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

diarrhea

Datatype

boolean

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

gastrointestinal bleeding

Datatype

boolean

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

intestinal obstruction

Datatype

boolean

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

active infection

Datatype

boolean

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

pulmonary disease

Datatype

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).
Beschrijving

serious complications

Datatype

boolean

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

cardiac disease

Datatype

boolean

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

multiple cancer

Datatype

boolean

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

neuropathy

Datatype

boolean

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

pregnancy, childbearing potential, breast feeding

Datatype

boolean

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

mental disorder

Datatype

boolean

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

allergic reaction

Datatype

boolean

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

ineligibility by investigation

Datatype

boolean

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

Eligibility Metastatic Colorectal Cancer NCT00316745

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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