ID

19751

Descrição

Efficacy Study of Additional Chemotherapy After Concurrent Chemoradiation in Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00326378

Link

https://clinicaltrials.gov/show/NCT00326378

Palavras-chave

Versões (1)
  1. 26/01/2017 26/01/2017 -
Transferido a

26 de janeiro de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00326378

Inglês

Eligibility Carcinoma, Non-Small-Cell Lung NCT00326378

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven non-small cell lung cancer
Descrição

Non-Small Cell Lung Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007131
presence of measurable disease by recist
Descrição

Measurable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
inoperable stage iiia or iiib, proven by ct or mri (except wet t4). however, n2 or n3 should be confirmed by pet or pathology. (for t4, pet is optional)
Descrição

TNM clinical staging Inoperable X-Ray Computed Tomography | Magnetic Resonance Imaging | TNM clinical staging Positron-Emission Tomography | TNM clinical staging Pathology

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C0205187
UMLS CUI [1,3]
C0040405
UMLS CUI [2]
C0024485
UMLS CUI [3,1]
C3258246
UMLS CUI [3,2]
C0032743
UMLS CUI [4,1]
C3258246
UMLS CUI [4,2]
C0919386
18 years of age or older
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0-1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
no prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
Descrição

Chemotherapy | Therapeutic radiology procedure Chest | Immunotherapy | Biological treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0817096
UMLS CUI [3]
C0021083
UMLS CUI [4]
C1531518
serum hgb ≥ 10 gm/dl, platelet ≥ 100,000/μl, absolute neutrophil count ≥ 1,500/μl
Descrição

Hemoglobin measurement | Platelet Count measurement | Absolute neutrophil count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0948762
serum creatinine ≤1.25 x unl or creatinine clearance ≥60 mlml/min
Descrição

Creatinine measurement, serum | Creatinine clearance measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
serum bilirubin ≤ 1.5 x unl, ast (sgot) and alt (sgpt) ≤ 2.5 x unl, alkaline phosphatase ≤ 5 x unl
Descrição

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201850
fev1> 0.8 l
Descrição

FEV1

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0748133
patients must sign an informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
carcinoid tumor, small cell carcinoma of lung
Descrição

Carcinoid Tumor | Small cell carcinoma of lung

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007095
UMLS CUI [2]
C0149925
patients with any distant metastasis
Descrição

Distant metastasis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1275402
history of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
Descrição

Malignant Neoplasms | Basal cell carcinoma Cured | Carcinoma in situ of uterine cervix Cured

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1880198
UMLS CUI [3,1]
C0851140
UMLS CUI [3,2]
C1880198
any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
Descrição

Medical contraindication Chemotherapy | Communicable Disease | Myocardial Infarction | Heart Disease Symptomatic | Angina, Unstable | Congestive heart failure | Cardiac Arrhythmia Uncontrolled | Therapeutic immunosuppression

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0392920
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0231220
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0018802
UMLS CUI [7,1]
C0003811
UMLS CUI [7,2]
C0205318
UMLS CUI [8]
C0021079
pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women
Descrição

Pregnancy | Breast Feeding | Gender Pregnancy Test Missing

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0032976
UMLS CUI [3,3]
C1705492
women and men of childbearing potential who have no willing of employing adequate contraception
Descrição

Childbearing Potential Contraceptive methods Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT00326378

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
histologically proven non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1])
Measurable Disease
Item
presence of measurable disease by recist
boolean
C1513041 (UMLS CUI [1])
TNM clinical staging Inoperable X-Ray Computed Tomography | Magnetic Resonance Imaging | TNM clinical staging Positron-Emission Tomography | TNM clinical staging Pathology
Item
inoperable stage iiia or iiib, proven by ct or mri (except wet t4). however, n2 or n3 should be confirmed by pet or pathology. (for t4, pet is optional)
boolean
C3258246 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0024485 (UMLS CUI [2])
C3258246 (UMLS CUI [3,1])
C0032743 (UMLS CUI [3,2])
C3258246 (UMLS CUI [4,1])
C0919386 (UMLS CUI [4,2])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Chemotherapy | Therapeutic radiology procedure Chest | Immunotherapy | Biological treatment
Item
no prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0817096 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3])
C1531518 (UMLS CUI [4])
Hemoglobin measurement | Platelet Count measurement | Absolute neutrophil count
Item
serum hgb ≥ 10 gm/dl, platelet ≥ 100,000/μl, absolute neutrophil count ≥ 1,500/μl
boolean
C0518015 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
Creatinine measurement, serum | Creatinine clearance measurement
Item
serum creatinine ≤1.25 x unl or creatinine clearance ≥60 mlml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
serum bilirubin ≤ 1.5 x unl, ast (sgot) and alt (sgpt) ≤ 2.5 x unl, alkaline phosphatase ≤ 5 x unl
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
FEV1
Item
fev1> 0.8 l
boolean
C0748133 (UMLS CUI [1])
Informed Consent
Item
patients must sign an informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Carcinoid Tumor | Small cell carcinoma of lung
Item
carcinoid tumor, small cell carcinoma of lung
boolean
C0007095 (UMLS CUI [1])
C0149925 (UMLS CUI [2])
Distant metastasis
Item
patients with any distant metastasis
boolean
C1275402 (UMLS CUI [1])
Malignant Neoplasms | Basal cell carcinoma Cured | Carcinoma in situ of uterine cervix Cured
Item
history of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1880198 (UMLS CUI [2,2])
C0851140 (UMLS CUI [3,1])
C1880198 (UMLS CUI [3,2])
Medical contraindication Chemotherapy | Communicable Disease | Myocardial Infarction | Heart Disease Symptomatic | Angina, Unstable | Congestive heart failure | Cardiac Arrhythmia Uncontrolled | Therapeutic immunosuppression
Item
any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
boolean
C1301624 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0002965 (UMLS CUI [5])
C0018802 (UMLS CUI [6])
C0003811 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C0021079 (UMLS CUI [8])
Pregnancy | Breast Feeding | Gender Pregnancy Test Missing
Item
pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
C1705492 (UMLS CUI [3,3])
Childbearing Potential Contraceptive methods Unwilling
Item
women and men of childbearing potential who have no willing of employing adequate contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
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