ID

27494

Description

Study of Camtobell Inj (Belotecan) on Weekly Schedule in Non-small Cell Lung Cancer (NSCLC) Patients Previously Treated With Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01022671

Link

https://clinicaltrials.gov/show/NCT01022671

Keywords

Versions (1)
  1. 11/17/17 11/17/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 17, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT01022671

English

Eligibility Carcinoma, Non-Small-Cell Lung NCT01022671

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
19 years and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
histologically or cytologically confirmed locally advanced or metastatic nsclc(stage iiib or iv)
Description

Non-Small Cell Lung Carcinoma Advanced Local TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0278987
UMLS CUI [2,2]
C3258246
≥ one measureable or evaluable lesion, <25% of the bone marrow had been irradiated
Description

Measurable lesion Quantity | Lesion Evaluable Quantity | Therapeutic radiology procedure Bone Marrow Percent

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1516986
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0005953
UMLS CUI [3,3]
C0439165
prior platinum based chemotherapy
Description

Chemotherapy Platinum-Based

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1514162
ecog ps ≤ 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
adequate organ function:
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
hematology: anc ≥ 1.5×109/l, platelet ≥ 100×109/l, hemoglobin ≥ 9.0g/dl
Description

Hematology | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0200627
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
hepatic: total bilirubin ≤ 1.5×uln, ast/alt ≤ 2.0×uln, alp ≤2.0×uln
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase 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
renal: serum creatinine ≤ 1.5×uln
Description

Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
signed a written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infection
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
symptomatic brain lesion
Description

Lesion of brain Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0221505
UMLS CUI [1,2]
C0231220
any other type of cancer during the previous 5 years except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
Description

Cancer Other | Exception Basal cell carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
severe concurrent diseases
Description

Comorbidity Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
prior anticancer therapy within 4 weeks before enroll
Description

Cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
active pregnancy test
Description

Pregnancy Test

Data type

boolean

Alias
UMLS CUI [1]
C0032976
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT01022671

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
19 years and older
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Advanced Local TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging
Item
histologically or cytologically confirmed locally advanced or metastatic nsclc(stage iiib or iv)
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Measurable lesion Quantity | Lesion Evaluable Quantity | Therapeutic radiology procedure Bone Marrow Percent
Item
≥ one measureable or evaluable lesion, <25% of the bone marrow had been irradiated
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C1516986 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0005953 (UMLS CUI [3,2])
C0439165 (UMLS CUI [3,3])
Chemotherapy Platinum-Based
Item
prior platinum based chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C1514162 (UMLS CUI [1,2])
ECOG performance status
Item
ecog ps ≤ 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Organ function
Item
adequate organ function:
boolean
C0678852 (UMLS CUI [1])
Hematology | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
hematology: anc ≥ 1.5×109/l, platelet ≥ 100×109/l, hemoglobin ≥ 9.0g/dl
boolean
C0200627 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
hepatic: total bilirubin ≤ 1.5×uln, ast/alt ≤ 2.0×uln, alp ≤2.0×uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
Renal function | Creatinine measurement, serum
Item
renal: serum creatinine ≤ 1.5×uln
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Informed Consent
Item
signed a written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Lesion of brain Symptomatic
Item
symptomatic brain lesion
boolean
C0221505 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
any other type of cancer during the previous 5 years except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Comorbidity Severe
Item
severe concurrent diseases
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Cancer treatment
Item
prior anticancer therapy within 4 weeks before enroll
boolean
C0920425 (UMLS CUI [1])
Pregnancy Test
Item
active pregnancy test
boolean
C0032976 (UMLS CUI [1])
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