ID

16508

Descripción

A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00152477

Link

https://clinicaltrials.gov/show/NCT00152477

Palabras clave

Versiones (2)
  1. 17/7/16 17/7/16 -
  2. 21/7/16 21/7/16 - Julian Varghese
Subido en

21 de julio de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Carcinoma NCT00152477

Inglés

Eligibility Carcinoma NCT00152477

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT00152477
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects with stage iiib (with malignant pleural effusion or if no pleural effusion is present subjects who are not candidates for combined modality therapy), stage iv, or recurrent non-squamous, non-small-cell lung carcinoma.
Descripción

Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007131
the subject must be aged 18 years or above.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
the subject must have ecog performance status of 0 or 1 and a life expectancy of at least three months.
Descripción

ECOG and life expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
subjects will have measurable disease.
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
the subject must be able to understand the information provided to them and to give written informed consent.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
female subjects must be either postmenopausal, surgically sterilized, or using a method of contraception judged reliable by the investigator.
Descripción

Childbearing Potential

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
male subjects must be using a method of contraception judged reliable by the investigator.
Descripción

Contraception

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with squamous cell lung carcinoma.
Descripción

Squamous cell lung carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0149782
subjects with lung lesions located centrally in the chest that involve major blood vessels.
Descripción

lung lesions located centrally in the chest

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0577916
UMLS CUI [1,2]
C0929406
concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. subjects with previous malignancies are eligible provided that they have been disease free for five years or more.
Descripción

Malignancies

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
presence of additional major chronic disease such as hepatic or renal dysfunction, cardiac dysfunction, peripheral vascular disease, evidence of a myocardial infarction within six months of screening visit, tuberculosis or epilepsy.
Descripción

additional major chronic disease

Tipo de datos

boolean

Alias
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0085096
UMLS CUI [5]
C0027051
UMLS CUI [6]
C0041296
UMLS CUI [7]
C0014544
subjects known to be infected with hepatitis b or c virus or hiv 1 or 2.
Descripción

hepatitis b or c virus or hiv 1 or 2

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
any evidence of serious active infection (ie requiring an iv antibiotic or antiviral agent).
Descripción

Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
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Similar models

Eligibility Carcinoma NCT00152477

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT00152477
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Lung Carcinoma
Item
male and female subjects with stage iiib (with malignant pleural effusion or if no pleural effusion is present subjects who are not candidates for combined modality therapy), stage iv, or recurrent non-squamous, non-small-cell lung carcinoma.
boolean
C0007131 (UMLS CUI [1])
Age
Item
the subject must be aged 18 years or above.
boolean
C0001779 (UMLS CUI [1])
ECOG and life expectancy
Item
the subject must have ecog performance status of 0 or 1 and a life expectancy of at least three months.
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Measurable Disease
Item
subjects will have measurable disease.
boolean
C1513041 (UMLS CUI [1])
Informed Consent
Item
the subject must be able to understand the information provided to them and to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential
Item
female subjects must be either postmenopausal, surgically sterilized, or using a method of contraception judged reliable by the investigator.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Contraception
Item
male subjects must be using a method of contraception judged reliable by the investigator.
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Squamous cell lung carcinoma
Item
subjects with squamous cell lung carcinoma.
boolean
C0149782 (UMLS CUI [1])
lung lesions located centrally in the chest
Item
subjects with lung lesions located centrally in the chest that involve major blood vessels.
boolean
C0577916 (UMLS CUI [1,1])
C0929406 (UMLS CUI [1,2])
Malignancies
Item
concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. subjects with previous malignancies are eligible provided that they have been disease free for five years or more.
boolean
C0006826 (UMLS CUI [1])
additional major chronic disease
Item
presence of additional major chronic disease such as hepatic or renal dysfunction, cardiac dysfunction, peripheral vascular disease, evidence of a myocardial infarction within six months of screening visit, tuberculosis or epilepsy.
boolean
C0232804 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0085096 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0041296 (UMLS CUI [6])
C0014544 (UMLS CUI [7])
hepatitis b or c virus or hiv 1 or 2
Item
subjects known to be infected with hepatitis b or c virus or hiv 1 or 2.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Infection
Item
any evidence of serious active infection (ie requiring an iv antibiotic or antiviral agent).
boolean
C0009450 (UMLS CUI [1])
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