ID

22139

Description

Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00466284

Link

https://clinicaltrials.gov/show/NCT00466284

Keywords

Versions (1)
  1. 5/21/17 5/21/17 -
Uploaded on

May 21, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00466284

English

Eligibility Non-Small Cell Lung Cancer NCT00466284

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage ia- iiib).
Description

Non-Small Cell Lung Carcinoma unresectable TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C1519810
UMLS CUI [1,3]
C3258246
measurable disease.
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
written informed consent must be obtained prior to the inclusion into the trial.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
karnofsky performance status of 80%.
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
patients must have been treated with no prior chemotherapy or radioterapy.
Description

Prior Chemotherapy Absent | Prior radiation therapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0332197
patients must have adequate bone marrow, liver and renal function.
Description

Bone Marrow function | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
bone marrow: wbc > 3000 x 103/mm3,
Description

Bone Marrow function | White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0023508
platelets > 100 x 103/mm3,
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
hgb > 10.0 gm/dl,
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
anc >1500 x 103/mm3,
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
hepatic:bilirubin < 2 mg/dl (34 µmol/l); ast, alt, and alkaline phosphatase < 5 x normal,
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:creatinine < 1.5 mg/dl (132 µmol/l).
Description

Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
female patients who are pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients who have used other investigational agents within 21 days prior to study entry.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
patients who have received prior treatment with erlotinib or other anti-egfr agent.
Description

erlotinib | Epidermal growth factor receptor inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C1135135
UMLS CUI [2]
C1443775
significant comorbidity.
Description

Comorbidity Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00466284

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 years.
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma unresectable TNM clinical staging
Item
patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage ia- iiib).
boolean
C0007131 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Measurable Disease
Item
measurable disease.
boolean
C1513041 (UMLS CUI [1])
Informed Consent
Item
written informed consent must be obtained prior to the inclusion into the trial.
boolean
C0021430 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance status of 80%.
boolean
C0206065 (UMLS CUI [1])
Prior Chemotherapy Absent | Prior radiation therapy Absent
Item
patients must have been treated with no prior chemotherapy or radioterapy.
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Bone Marrow function | Liver function | Renal function
Item
patients must have adequate bone marrow, liver and renal function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Bone Marrow function | White Blood Cell Count procedure
Item
bone marrow: wbc > 3000 x 103/mm3,
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0023508 (UMLS CUI [2])
Platelet Count measurement
Item
platelets > 100 x 103/mm3,
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hgb > 10.0 gm/dl,
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
anc >1500 x 103/mm3,
boolean
C0948762 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
hepatic:bilirubin < 2 mg/dl (34 µmol/l); ast, alt, and alkaline phosphatase < 5 x normal,
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:creatinine < 1.5 mg/dl (132 µmol/l).
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
female patients who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
patients who have used other investigational agents within 21 days prior to study entry.
boolean
C0013230 (UMLS CUI [1])
erlotinib | Epidermal growth factor receptor inhibitor
Item
patients who have received prior treatment with erlotinib or other anti-egfr agent.
boolean
C1135135 (UMLS CUI [1])
C1443775 (UMLS CUI [2])
Comorbidity Significant
Item
significant comorbidity.
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
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