ID

22014

Beschreibung

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

Stichworte

Versionen (1)
  1. 14.05.17 14.05.17 -
Hochgeladen am

14. Mai 2017

DOI

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Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT00316745

Englisch

Eligibility Metastatic Colorectal Cancer NCT00316745

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

colorectal cancer

Datentyp

boolean

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

age

Datentyp

text

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

prior chemotherapy

Datentyp

text

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

ecog

Datentyp

text

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

life expectancy

Datentyp

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.
Beschreibung

organ function, hematologic, hepatic, renal function

Datentyp

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.
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

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.
Beschreibung

blood products, granulocyte colony stimulating factor

Datentyp

boolean

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

oral intake

Datentyp

boolean

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

flucytosine

Datentyp

boolean

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

pleural effusion, ascites

Datentyp

boolean

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

brain metastasis

Datentyp

boolean

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

diarrhea

Datentyp

boolean

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

gastrointestinal bleeding

Datentyp

boolean

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

intestinal obstruction

Datentyp

boolean

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

active infection

Datentyp

boolean

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

pulmonary disease

Datentyp

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).
Beschreibung

serious complications

Datentyp

boolean

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

cardiac disease

Datentyp

boolean

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

multiple cancer

Datentyp

boolean

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

neuropathy

Datentyp

boolean

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

pregnancy, childbearing potential, breast feeding

Datentyp

boolean

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

mental disorder

Datentyp

boolean

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

allergic reaction

Datentyp

boolean

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

ineligibility by investigation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C1512714
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Ähnliche Modelle

Eligibility Metastatic Colorectal Cancer NCT00316745

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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