ID

15596

Description

Docetaxel and Gemcitabine With Filgrastim-SD/01 Support in Patients With Advanced Non-Small Cell Lung Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00050674

Link

https://clinicaltrials.gov/show/NCT00050674

Keywords

Versions (1)
  1. 6/4/16 6/4/16 -
Uploaded on

June 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00050674

English

Eligibility Non-small Cell Lung Cancer NCT00050674

1 forms  
Criteria
Description

Criteria

subjects must have stage iv or iiib nsclc
Description

nsclc

Data type

boolean

Alias
UMLS CUI [1]
C0007131
0-1 prior treatment regimens of chemotherapy
Description

regimens of chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0449788
subjects must have bi-dimensionally measurable disease or evaluable disease by physical exam or radiological studies
Description

measurable disease or evaluable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
age > 18 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
1st line - ecog 0-2
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
2nd line - ecog 0-1
Description

ecog 2nd line

Data type

boolean

Alias
UMLS CUI [1]
C1520224
absolute neutrophil count > or = 1.5 x 10 to the 9th power/l
Description

absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count > or = 100 x 10 to the 9th power/l
Description

platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0005821
adequate renal function with screening serum creatinine < or = 2.0 mg/dl
Description

renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
adequate ast and alt no more than 1.5 x the upper limit of normal and serum bilirubin < or = upper limit of normal
Description

adequate ast and alt

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1278039
subjects must be at least two weeks from prior major thoracic or abdominal surgery and at least two weeks from completion of radiation therapy, and recovered from all toxicities associated with these treatments
Description

time between major surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0872291
UMLS CUI [1,2]
C0087111
negative hcg by urine or blood test in subject of child-bearing potential
Description

negative hcg

Data type

boolean

Alias
UMLS CUI [1,1]
C1141639
UMLS CUI [1,2]
C0205160
life expectancy > 2 months
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
ethical - before any study specific procedure is done or before study medication is administered, the subject or legally acceptable representative must give informed consent for participation in the study
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Non-small Cell Lung Cancer NCT00050674

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
nsclc
Item
subjects must have stage iv or iiib nsclc
boolean
C0007131 (UMLS CUI [1])
regimens of chemotherapy
Item
0-1 prior treatment regimens of chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
measurable disease or evaluable disease
Item
subjects must have bi-dimensionally measurable disease or evaluable disease by physical exam or radiological studies
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
ecog
Item
1st line - ecog 0-2
boolean
C1520224 (UMLS CUI [1])
ecog 2nd line
Item
2nd line - ecog 0-1
boolean
C1520224 (UMLS CUI [1])
absolute neutrophil count
Item
absolute neutrophil count > or = 1.5 x 10 to the 9th power/l
boolean
C0948762 (UMLS CUI [1])
platelet count
Item
platelet count > or = 100 x 10 to the 9th power/l
boolean
C0005821 (UMLS CUI [1])
renal function
Item
adequate renal function with screening serum creatinine < or = 2.0 mg/dl
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
adequate ast and alt
Item
adequate ast and alt no more than 1.5 x the upper limit of normal and serum bilirubin < or = upper limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
time between major surgery
Item
subjects must be at least two weeks from prior major thoracic or abdominal surgery and at least two weeks from completion of radiation therapy, and recovered from all toxicities associated with these treatments
boolean
C0872291 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
negative hcg
Item
negative hcg by urine or blood test in subject of child-bearing potential
boolean
C1141639 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
life expectancy
Item
life expectancy > 2 months
boolean
C0023671 (UMLS CUI [1])
informed consent
Item
ethical - before any study specific procedure is done or before study medication is administered, the subject or legally acceptable representative must give informed consent for participation in the study
boolean
C0021430 (UMLS CUI [1])
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