ID

32570

Description

Erlotinib Versus Gefitinib in Advanced Non Small Cell Lung Cancer With exon21 Mutation：A Randomized Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01024413

Link

https://clinicaltrials.gov/show/NCT01024413

Keywords

Versions (1)
  1. 11/6/18 11/6/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 6, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Thoracic Neoplasms NCT01024413

English

Eligibility Thoracic Neoplasms NCT01024413

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological or cytological documented stage iv or wet iiib nsclc.
Description

Non-Small Cell Lung Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
no systemic antic cancer treatment or pd after first or second line chemotherapy.
Description

Absence Cancer treatment Systemic | Progressive Disease Post First line Chemotherapy | Progressive Disease Post Second line Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C0205373
UMLS CUI [2,1]
C1335499
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C1708063
UMLS CUI [2,4]
C0392920
UMLS CUI [3,1]
C1335499
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C1710038
UMLS CUI [3,4]
C0392920
gene analyses of tumor tissue confirmed exon21 egfr mutation.
Description

Genetic Analysis Tumor tissue | EGFR Exon 21 Mutation

Data type

boolean

Alias
UMLS CUI [1,1]
C0796344
UMLS CUI [1,2]
C0475358
UMLS CUI [2]
C4289654
signed inform consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
enough vital organ function.
Description

Organ function Vital

Data type

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0442732
patient has recovered from ctcae grade 3/4 toxicity.
Description

Toxicity CTCAE Grades | Patient recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1516728
UMLS CUI [2]
C1115804
ecog performance status 0, 1 or 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
haemoglobin>10.0 g/dl, absolute neutrophil count (anc) >1.5 x 109/l,platelets100 x 109/l.
Description

Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
total bilirubin<1.5 x upper limit of normal (uln),alt and ast<2.5 x uln in the absence of liver metastases, or<5 x uln in case of liver metastases.
Description

Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4,1]
C0494165
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C0494165
creatinine clearance < 2.0 x uln .
Description

Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
fail to acquire the inform consent.
Description

Informed Consent failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0231175
pregnant or breast-feeding women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
unable to swallow the drug.
Description

Lacking Able to swallow Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0013230
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Similar models

Eligibility Thoracic Neoplasms NCT01024413

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histological or cytological documented stage iv or wet iiib nsclc.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Absence Cancer treatment Systemic | Progressive Disease Post First line Chemotherapy | Progressive Disease Post Second line Chemotherapy
Item
no systemic antic cancer treatment or pd after first or second line chemotherapy.
boolean
C0332197 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C1335499 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1708063 (UMLS CUI [2,3])
C0392920 (UMLS CUI [2,4])
C1335499 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1710038 (UMLS CUI [3,3])
C0392920 (UMLS CUI [3,4])
Genetic Analysis Tumor tissue | EGFR Exon 21 Mutation
Item
gene analyses of tumor tissue confirmed exon21 egfr mutation.
boolean
C0796344 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C4289654 (UMLS CUI [2])
Informed Consent
Item
signed inform consent.
boolean
C0021430 (UMLS CUI [1])
Organ function Vital
Item
enough vital organ function.
boolean
C0678852 (UMLS CUI [1,1])
C0442732 (UMLS CUI [1,2])
Toxicity CTCAE Grades | Patient recovered
Item
patient has recovered from ctcae grade 3/4 toxicity.
boolean
C0600688 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1115804 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status 0, 1 or 2.
boolean
C1520224 (UMLS CUI [1])
Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement
Item
haemoglobin>10.0 g/dl, absolute neutrophil count (anc) >1.5 x 109/l,platelets100 x 109/l.
boolean
C0518015 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver
Item
total bilirubin<1.5 x upper limit of normal (uln),alt and ast<2.5 x uln in the absence of liver metastases, or<5 x uln in case of liver metastases.
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0494165 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0494165 (UMLS CUI [5])
Creatinine clearance measurement
Item
creatinine clearance < 2.0 x uln .
boolean
C0373595 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Informed Consent failed
Item
fail to acquire the inform consent.
boolean
C0021430 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Lacking Able to swallow Investigational New Drugs
Item
unable to swallow the drug.
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
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