ID

13775

Description

Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations; ODM derived from: https://clinicaltrials.gov/show/NCT01470716

Link

https://clinicaltrials.gov/show/NCT01470716

Keywords

Versions (1)
  1. 3/6/16 3/6/16 -
Uploaded on

March 6, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer Stage II NCT01470716

English

Eligibility Non-small Cell Lung Cancer Stage II NCT01470716

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically confirmed stage ii & iiia non-small cell lung cancer
Description

tumor stage non-small cell lung cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C0007131
egfr exon 19 or 21 mutations
Description

EGFR gene mutation

Data type

boolean

Alias
UMLS CUI [1]
C3266992
age ≥ 18 years and ecog performance 0~1
Description

age; ecog

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1520224
has measurable lesion by recist 1.1
Description

lesion

Data type

boolean

Alias
UMLS CUI [1]
C0221198
no previous chemotherapy or radiation therapy
Description

chemotherapy; radiation therapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
adequate organ function by following; anc ≥1,500/ul, hemoglobin ≥9.0g/dl, platelet ≥100,000/ul, pao2 ≥ 60 mmhg, serum cr < 1 x unl or creatinine clearance > 60 ml/min, serum bilirubin < 1 x unl, ast (sgot) and alt (sgpt) < 2.5 x unl, alkaline phosphatase < 5 x unl
Description

Absolute neutrophil count; hemoglobin; platelet; pao2; Serum creatine; creatinine clearance; serum bilirubin; ast and alt; alkaline phosphatase

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0202155
UMLS CUI [5]
C0858112
UMLS CUI [6]
C0373595
UMLS CUI [7]
C0428441
UMLS CUI [8]
C3831581
UMLS CUI [9]
C0002059
written informed consent form
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous chemotherapy or radiation therapy
Description

chemotherapy; radiation therapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ
Description

medical history malignancy; skin cancer; cervical cancer in situ

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0006826
UMLS CUI [2]
C0007114
UMLS CUI [3]
C0742130
known allergic history of erlotinib
Description

hypersensitivity erlotinib

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1135135
interstitial lung disease or fibrosis on chest radiogram
Description

interstitial lung disease; Chest x-ray findings; Interstitial lung fibrosis

Data type

boolean

Alias
UMLS CUI [1]
C0206062
UMLS CUI [2]
C1821150
UMLS CUI [3]
C3887486
active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
Description

infection; cardiopulmonary insufficiency; arrhythmias; hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C3714514
UMLS CUI [2]
C0920033
UMLS CUI [3]
C0003811
UMLS CUI [4]
C0019158
pregnant or nursing women
Description

pregnancy; lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Non-small Cell Lung Cancer Stage II NCT01470716

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
tumor stage non-small cell lung cancer
Item
pathologically confirmed stage ii & iiia non-small cell lung cancer
boolean
C1300072 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
EGFR gene mutation
Item
egfr exon 19 or 21 mutations
boolean
C3266992 (UMLS CUI [1])
age; ecog
Item
age ≥ 18 years and ecog performance 0~1
boolean
C0001779 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
lesion
Item
has measurable lesion by recist 1.1
boolean
C0221198 (UMLS CUI [1])
chemotherapy; radiation therapy
Item
no previous chemotherapy or radiation therapy
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Absolute neutrophil count; hemoglobin; platelet; pao2; Serum creatine; creatinine clearance; serum bilirubin; ast and alt; alkaline phosphatase
Item
adequate organ function by following; anc ≥1,500/ul, hemoglobin ≥9.0g/dl, platelet ≥100,000/ul, pao2 ≥ 60 mmhg, serum cr < 1 x unl or creatinine clearance > 60 ml/min, serum bilirubin < 1 x unl, ast (sgot) and alt (sgpt) < 2.5 x unl, alkaline phosphatase < 5 x unl
boolean
C0948762 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0202155 (UMLS CUI [4])
C0858112 (UMLS CUI [5])
C0373595 (UMLS CUI [6])
C0428441 (UMLS CUI [7])
C3831581 (UMLS CUI [8])
C0002059 (UMLS CUI [9])
informed consent
Item
written informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
chemotherapy; radiation therapy
Item
previous chemotherapy or radiation therapy
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
medical history malignancy; skin cancer; cervical cancer in situ
Item
previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0007114 (UMLS CUI [2])
C0742130 (UMLS CUI [3])
hypersensitivity erlotinib
Item
known allergic history of erlotinib
boolean
C0020517 (UMLS CUI [1,1])
C1135135 (UMLS CUI [1,2])
interstitial lung disease; Chest x-ray findings; Interstitial lung fibrosis
Item
interstitial lung disease or fibrosis on chest radiogram
boolean
C0206062 (UMLS CUI [1])
C1821150 (UMLS CUI [2])
C3887486 (UMLS CUI [3])
infection; cardiopulmonary insufficiency; arrhythmias; hepatitis
Item
active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
boolean
C3714514 (UMLS CUI [1])
C0920033 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C0019158 (UMLS CUI [4])
pregnancy; lactating
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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