ID

23732

Descripción

Vinorelbine Tartrate and Paclitaxel in Treating Older Patients With Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00602797

Link

https://clinicaltrials.gov/show/NCT00602797

Palabras clave

Versiones (1)
  1. 12/7/17 12/7/17 -
Subido en

12 de julio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Recurrent Non-small Cell Lung Cancer NCT00602797

Inglés

Eligibility Recurrent Non-small Cell Lung Cancer NCT00602797

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically proven non-small cell lung cancer with evidence of distant metastases/malignant pleural effusion
Descripción

ID.1

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0027627
measurable disease on imaging studies in 2 dimensions
Descripción

ID.2

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
no previous therapy with either paclitaxel or vinorelbine, or any chemotherapy for the past five years
Descripción

ID.3

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0144576
UMLS CUI [1,2]
C0078257
UMLS CUI [1,3]
C0392920
patients who have had a previous resection for their lung cancer and present with recurrent disease will be eligible
Descripción

ID.4

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C0684249
patients with other prior malignancies will be included, provided they have been disease-free for at least five years
Descripción

ID.5

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0242793
patients with adequately treated basal cell or squamous cell carcinoma of the skin, adequately treated carcinoma in-situ of the cervix and hormone sensitive prostate cancer will be eligible
Descripción

ID.6

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007118
UMLS CUI [1,2]
C0851140
UMLS CUI [1,3]
C4302896
karnofsky score >= 70 (eastern cooperative oncology group [ecog] 0-2)
Descripción

ID.7

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0206065
UMLS CUI [1,2]
C1520224
white blood cell (wbc) count >= 3,500/mm^3, or
Descripción

ID.8

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count (anc) >= 1,500/ul
Descripción

ID.9

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
platelet count >= 100,000/mm^3
Descripción

ID.10

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
serum creatinine less than 1.5 times the upper limits of normal
Descripción

ID.11

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0600061
serum aspartate aminotransferase (ast) and alanine aminotransferase (alt) less than 1.5 times the upper limits of normal
Descripción

ID.12

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004002
UMLS CUI [1,2]
C0001899
serum alkaline phosphatase less than 2.5 times the upper limits of normal
Descripción

ID.13

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036776
no active serious infections or other condition precluding chemotherapy
Descripción

ID.14

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3714514
non-pregnant and non-nursing
Descripción

ID.15

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on the study
Descripción

ID.16

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009862
able to give informed consent
Descripción

ID.17

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
able to return for treatment and follow-up as specified in the protocol
Descripción

ID.18

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3274571
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity to any component of vinorelbine or paclitaxel or other required drugs in the study
Descripción

ID.19

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0078257
UMLS CUI [1,3]
C0144576
any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
Descripción

ID.20

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
inability to fulfill the requirements of the protocol
Descripción

ID.21

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Recurrent Non-small Cell Lung Cancer NCT00602797

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
pathologically proven non-small cell lung cancer with evidence of distant metastases/malignant pleural effusion
boolean
C0007131 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
ID.2
Item
measurable disease on imaging studies in 2 dimensions
boolean
C1513041 (UMLS CUI [1])
ID.3
Item
no previous therapy with either paclitaxel or vinorelbine, or any chemotherapy for the past five years
boolean
C0144576 (UMLS CUI [1,1])
C0078257 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
ID.4
Item
patients who have had a previous resection for their lung cancer and present with recurrent disease will be eligible
boolean
C0728940 (UMLS CUI [1,1])
C0684249 (UMLS CUI [1,2])
ID.5
Item
patients with other prior malignancies will be included, provided they have been disease-free for at least five years
boolean
C0006826 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0242793 (UMLS CUI [1,3])
ID.6
Item
patients with adequately treated basal cell or squamous cell carcinoma of the skin, adequately treated carcinoma in-situ of the cervix and hormone sensitive prostate cancer will be eligible
boolean
C0007118 (UMLS CUI [1,1])
C0851140 (UMLS CUI [1,2])
C4302896 (UMLS CUI [1,3])
ID.7
Item
karnofsky score >= 70 (eastern cooperative oncology group [ecog] 0-2)
boolean
C0206065 (UMLS CUI [1,1])
C1520224 (UMLS CUI [1,2])
ID.8
Item
white blood cell (wbc) count >= 3,500/mm^3, or
boolean
C0023508 (UMLS CUI [1])
ID.9
Item
absolute neutrophil count (anc) >= 1,500/ul
boolean
C0948762 (UMLS CUI [1])
ID.10
Item
platelet count >= 100,000/mm^3
boolean
C0032181 (UMLS CUI [1])
ID.11
Item
serum creatinine less than 1.5 times the upper limits of normal
boolean
C0600061 (UMLS CUI [1])
ID.12
Item
serum aspartate aminotransferase (ast) and alanine aminotransferase (alt) less than 1.5 times the upper limits of normal
boolean
C0004002 (UMLS CUI [1,1])
C0001899 (UMLS CUI [1,2])
ID.13
Item
serum alkaline phosphatase less than 2.5 times the upper limits of normal
boolean
C0036776 (UMLS CUI [1])
ID.14
Item
no active serious infections or other condition precluding chemotherapy
boolean
C3714514 (UMLS CUI [1])
ID.15
Item
non-pregnant and non-nursing
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
ID.16
Item
men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on the study
boolean
C0009862 (UMLS CUI [1])
ID.17
Item
able to give informed consent
boolean
C0021430 (UMLS CUI [1])
ID.18
Item
able to return for treatment and follow-up as specified in the protocol
boolean
C3274571 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.19
Item
known hypersensitivity to any component of vinorelbine or paclitaxel or other required drugs in the study
boolean
C0020517 (UMLS CUI [1,1])
C0078257 (UMLS CUI [1,2])
C0144576 (UMLS CUI [1,3])
ID.20
Item
any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
boolean
C0009488 (UMLS CUI [1])
ID.21
Item
inability to fulfill the requirements of the protocol
boolean
C1321605 (UMLS CUI [1])
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