ID

31113

Descrição

Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR; ODM derived from: https://clinicaltrials.gov/show/NCT00567359

Link

https://clinicaltrials.gov/show/NCT00567359

Palavras-chave

Versões (1)
  1. 21/07/2018 21/07/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

21 de julho de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00567359

Inglês

Eligibility Non-small Cell Lung Cancer NCT00567359

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically confirmed diagnosis of nsclc of adenocarcinoma histology
Descrição

Non-Small Cell Lung Carcinoma | Adenocarcinoma Histology

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C0001418
UMLS CUI [2,2]
C4048239
stage ia-b, iia-b, or iiia by the american joint committee on cancer 7th edition staging criteria
Descrição

TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3258246
patients must have undergone surgical resection with curative intent within 6 months of enrollment
Descrição

Excision Curative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C1276305
sufficient tumor tissue available for egfr mutation analysis
Descrição

Availability of Tumor tissue Sufficient | EGFR gene mutation Analysis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [1,3]
C0205410
UMLS CUI [2,1]
C3266992
UMLS CUI [2,2]
C0002778
at least one of the following patient characteristics: previously detected deletion 19 or l858r egfr mutation, female sex, history of never smoking, or asian/pacific rim ethnicity (to be enrolled in the screening portion of trial).
Descrição

Client Characteristics | EGFR exon 19 deletion | Point mutation in exon 21 (L858R) | Gender | Never smoked tobacco | Asians

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0815172
UMLS CUI [2]
C3889117
UMLS CUI [3]
C3888903
UMLS CUI [4]
C0079399
UMLS CUI [5]
C0425293
UMLS CUI [6]
C0078988
18 years of age or older
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
tumor samples must have either exon 19 deletion mutations or the exon 21 l858r point mutation
Descrição

Tumor tissue sample EGFR exon 19 deletion | Tumor tissue sample Point mutation in exon 21 (L858R)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C3889117
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C3888903
ecog performance status of 0,1, or 2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function as outlined in protocol
Descrição

Organ function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
radiographic evidence of recurrent nsclc prior to erlotinib treatment
Descrição

Non-small cell lung cancer recurrent Radiography | erlotinib

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0278517
UMLS CUI [1,2]
C0034571
UMLS CUI [2]
C1135135
confirmed t790m resistance mutation in the primary tumor sample
Descrição

EGFR T790M Resistance Mutation | Tumor tissue sample Primary

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3274192
UMLS CUI [1,2]
C1514892
UMLS CUI [1,3]
C0026882
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C0205225
prior exposure to egfr tyrosine kinase inhibitors
Descrição

Exposure to EGFR Tyrosine Kinase Inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1443775
known hypersensitivity to erlotinib, gefitinib, or any closely related drug
Descrição

Hypersensitivity Erlotinib | Hypersensitivity Gefitinib | Hypersensitivity Pharmaceutical Preparations Related

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1135135
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1122962
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0439849
pregnant or breastfeeding women
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any evidence of clinically active interstitial lung disease
Descrição

Lung Diseases, Interstitial

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206062
current use of enzyme-inducing anti-epileptic drugs, including carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, and primidone
Descrição

Antiepileptic Agents Enzyme Inducing | Carbamazepine | oxcarbazepine | Phenytoin | fosphenytoin | Phenobarbital | Primidone

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0014442
UMLS CUI [1,3]
C0205263
UMLS CUI [2]
C0006949
UMLS CUI [3]
C0069751
UMLS CUI [4]
C0031507
UMLS CUI [5]
C0244656
UMLS CUI [6]
C0031412
UMLS CUI [7]
C0033148
evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
Descrição

Disease Study Subject Participation Status Unfavorable | Laboratory finding Study Subject Participation Status Unfavorable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C3640815
UMLS CUI [2,1]
C0587081
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C3640815
use of any non-fda approved or investigational agent within 2 weeks of enrolling onto the trial, or failure to recover from the side effects of any of these agents
Descrição

Drugs, Non-Prescription | Investigational New Drugs | Side effects Pharmaceutical Preparations Recovery failed

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C0879626
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C2004454
UMLS CUI [3,4]
C0231175
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Similar models

Eligibility Non-small Cell Lung Cancer NCT00567359

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | Adenocarcinoma Histology
Item
pathologically confirmed diagnosis of nsclc of adenocarcinoma histology
boolean
C0007131 (UMLS CUI [1])
C0001418 (UMLS CUI [2,1])
C4048239 (UMLS CUI [2,2])
TNM clinical staging
Item
stage ia-b, iia-b, or iiia by the american joint committee on cancer 7th edition staging criteria
boolean
C3258246 (UMLS CUI [1])
Excision Curative
Item
patients must have undergone surgical resection with curative intent within 6 months of enrollment
boolean
C0728940 (UMLS CUI [1,1])
C1276305 (UMLS CUI [1,2])
Availability of Tumor tissue Sufficient | EGFR gene mutation Analysis
Item
sufficient tumor tissue available for egfr mutation analysis
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0205410 (UMLS CUI [1,3])
C3266992 (UMLS CUI [2,1])
C0002778 (UMLS CUI [2,2])
Client Characteristics | EGFR exon 19 deletion | Point mutation in exon 21 (L858R) | Gender | Never smoked tobacco | Asians
Item
at least one of the following patient characteristics: previously detected deletion 19 or l858r egfr mutation, female sex, history of never smoking, or asian/pacific rim ethnicity (to be enrolled in the screening portion of trial).
boolean
C0815172 (UMLS CUI [1])
C3889117 (UMLS CUI [2])
C3888903 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
C0425293 (UMLS CUI [5])
C0078988 (UMLS CUI [6])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Tumor tissue sample EGFR exon 19 deletion | Tumor tissue sample Point mutation in exon 21 (L858R)
Item
tumor samples must have either exon 19 deletion mutations or the exon 21 l858r point mutation
boolean
C0475358 (UMLS CUI [1,1])
C3889117 (UMLS CUI [1,2])
C0475358 (UMLS CUI [2,1])
C3888903 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status of 0,1, or 2
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
adequate organ function as outlined in protocol
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Non-small cell lung cancer recurrent Radiography | erlotinib
Item
radiographic evidence of recurrent nsclc prior to erlotinib treatment
boolean
C0278517 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C1135135 (UMLS CUI [2])
EGFR T790M Resistance Mutation | Tumor tissue sample Primary
Item
confirmed t790m resistance mutation in the primary tumor sample
boolean
C3274192 (UMLS CUI [1,1])
C1514892 (UMLS CUI [1,2])
C0026882 (UMLS CUI [1,3])
C0475358 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
Exposure to EGFR Tyrosine Kinase Inhibitors
Item
prior exposure to egfr tyrosine kinase inhibitors
boolean
C0332157 (UMLS CUI [1,1])
C1443775 (UMLS CUI [1,2])
Hypersensitivity Erlotinib | Hypersensitivity Gefitinib | Hypersensitivity Pharmaceutical Preparations Related
Item
known hypersensitivity to erlotinib, gefitinib, or any closely related drug
boolean
C0020517 (UMLS CUI [1,1])
C1135135 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1122962 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Lung Diseases, Interstitial
Item
any evidence of clinically active interstitial lung disease
boolean
C0206062 (UMLS CUI [1])
Antiepileptic Agents Enzyme Inducing | Carbamazepine | oxcarbazepine | Phenytoin | fosphenytoin | Phenobarbital | Primidone
Item
current use of enzyme-inducing anti-epileptic drugs, including carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, and primidone
boolean
C0003299 (UMLS CUI [1,1])
C0014442 (UMLS CUI [1,2])
C0205263 (UMLS CUI [1,3])
C0006949 (UMLS CUI [2])
C0069751 (UMLS CUI [3])
C0031507 (UMLS CUI [4])
C0244656 (UMLS CUI [5])
C0031412 (UMLS CUI [6])
C0033148 (UMLS CUI [7])
Disease Study Subject Participation Status Unfavorable | Laboratory finding Study Subject Participation Status Unfavorable
Item
evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
Drugs, Non-Prescription | Investigational New Drugs | Side effects Pharmaceutical Preparations Recovery failed
Item
use of any non-fda approved or investigational agent within 2 weeks of enrolling onto the trial, or failure to recover from the side effects of any of these agents
boolean
C0013231 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0879626 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C2004454 (UMLS CUI [3,3])
C0231175 (UMLS CUI [3,4])
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