ID

32583

Descrição

Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01192243

Link

https://clinicaltrials.gov/show/NCT01192243

Palavras-chave

Versões (1)
  1. 07/11/2018 07/11/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

7 de novembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Toxicity NCT01192243

Inglês

Eligibility Toxicity NCT01192243

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Toxicity NCT01192243
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who were diagnosed by the histologic, cytologic diagnosis of iv non-small cell lung cancer
Descrição

Non-Small Cell Lung Carcinoma TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
age from 18 to 70 years old
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
at least one target lesion diameter spiral ct ≥ 1 cm, or the common ct ≥ 2 cm, and can be measured by imaging tools
Descrição

Target Lesion Quantity Diameter Spiral CT | Target Lesion Quantity Diameter CT | Measurable lesion Imaging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1301886
UMLS CUI [1,4]
C0860888
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1301886
UMLS CUI [2,4]
C0040405
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0079595
ecog 0-1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
expected life time longer than 12 weeks
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
normal laboratory values:
Descrição

Normal Laboratory Test Result

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0438214
leucocyte≥ 4×109/l neutrophil≥ 1.5×109/l platelet≥100×109/l hemoglobin≥ 10g/l alt and ast
Descrição

White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201899
≤2.5×uln (≤5×uln if liver metastasis)
Descrição

Relationship Secondary malignant neoplasm of liver

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0494165
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients have not used drugs according to protocol
Descrição

Pharmaceutical Preparations Inconsistent Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C2348563
patients were allergic to pemetrexed or cisplatin
Descrição

Hypersensitivity Pemetrexed | Cisplatin allergy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0210657
UMLS CUI [2]
C0570702
patients received radiotherapy or other biological treatment 4 weeks before the trial
Descrição

Therapeutic radiology procedure | Biological treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C1531518
uncontrolled hydrothorax or hydropericardium
Descrição

Hydrothorax Uncontrolled | Hydropericardium Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020312
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0349077
UMLS CUI [2,2]
C0205318
neuropathy toxicity ≥ ctc 3
Descrição

Neuropathy Toxicity CTCAE Grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0600688
UMLS CUI [1,3]
C1516728
severe symptomatic heart disease
Descrição

Heart Disease Symptomatic Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0205082
active upper gastrointestinal ulcer or digestive disfunction
Descrição

Peptic Ulcer Upper Gastrointestinal Tract | Dysfunction Digestive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030920
UMLS CUI [1,2]
C3203348
UMLS CUI [2,1]
C3887504
UMLS CUI [2,2]
C0012238
severe infection or metabolic disfunction
Descrição

Communicable Disease Severe | Dysfunction Metabolic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C3887504
UMLS CUI [2,2]
C0311400
patients with other malignant tumor
Descrição

Cancer Other

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
uncontrolled brain metastases
Descrição

Metastatic malignant neoplasm to brain Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205318
patients have accepted other clinical trials
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
female patients during their pregnant and lactation period, or patients without contraception
Descrição

Pregnancy | Breast Feeding | Contraceptive methods Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0332197
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Similar models

Eligibility Toxicity NCT01192243

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Toxicity NCT01192243
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
patients who were diagnosed by the histologic, cytologic diagnosis of iv non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Age
Item
age from 18 to 70 years old
boolean
C0001779 (UMLS CUI [1])
Target Lesion Quantity Diameter Spiral CT | Target Lesion Quantity Diameter CT | Measurable lesion Imaging
Item
at least one target lesion diameter spiral ct ≥ 1 cm, or the common ct ≥ 2 cm, and can be measured by imaging tools
boolean
C2986546 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0860888 (UMLS CUI [1,4])
C2986546 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0040405 (UMLS CUI [2,4])
C1513041 (UMLS CUI [3,1])
C0079595 (UMLS CUI [3,2])
ECOG performance status
Item
ecog 0-1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
expected life time longer than 12 weeks
boolean
C0023671 (UMLS CUI [1])
Normal Laboratory Test Result
Item
normal laboratory values:
boolean
C0438214 (UMLS CUI [1])
White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
leucocyte≥ 4×109/l neutrophil≥ 1.5×109/l platelet≥100×109/l hemoglobin≥ 10g/l alt and ast
boolean
C0023508 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
Relationship Secondary malignant neoplasm of liver
Item
≤2.5×uln (≤5×uln if liver metastasis)
boolean
C0439849 (UMLS CUI [1,1])
C0494165 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Inconsistent Study Protocol
Item
patients have not used drugs according to protocol
boolean
C0013227 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Hypersensitivity Pemetrexed | Cisplatin allergy
Item
patients were allergic to pemetrexed or cisplatin
boolean
C0020517 (UMLS CUI [1,1])
C0210657 (UMLS CUI [1,2])
C0570702 (UMLS CUI [2])
Therapeutic radiology procedure | Biological treatment
Item
patients received radiotherapy or other biological treatment 4 weeks before the trial
boolean
C1522449 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
Hydrothorax Uncontrolled | Hydropericardium Uncontrolled
Item
uncontrolled hydrothorax or hydropericardium
boolean
C0020312 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0349077 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Neuropathy Toxicity CTCAE Grades
Item
neuropathy toxicity ≥ ctc 3
boolean
C0442874 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Heart Disease Symptomatic Severe
Item
severe symptomatic heart disease
boolean
C0018799 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Peptic Ulcer Upper Gastrointestinal Tract | Dysfunction Digestive
Item
active upper gastrointestinal ulcer or digestive disfunction
boolean
C0030920 (UMLS CUI [1,1])
C3203348 (UMLS CUI [1,2])
C3887504 (UMLS CUI [2,1])
C0012238 (UMLS CUI [2,2])
Communicable Disease Severe | Dysfunction Metabolic
Item
severe infection or metabolic disfunction
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3887504 (UMLS CUI [2,1])
C0311400 (UMLS CUI [2,2])
Cancer Other
Item
patients with other malignant tumor
boolean
C1707251 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Uncontrolled
Item
uncontrolled brain metastases
boolean
C0220650 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Study Subject Participation Status
Item
patients have accepted other clinical trials
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding | Contraceptive methods Absent
Item
female patients during their pregnant and lactation period, or patients without contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
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