ID

22436

Descrição

Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00678964

Link

https://clinicaltrials.gov/show/NCT00678964

Palavras-chave

Versões (1)
  1. 04/06/2017 04/06/2017 -
Transferido a

4 de junho de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00678964

Inglês

Eligibility Non-Small Cell Lung Cancer NCT00678964

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytological proven nsclc, stage lll b (with pleural effusion) or stage lv.
Descrição

nsclc, tumor stage

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C1300072
tumor is locally advanced and not suitable for surgery and radiotherapy is not indicated.
Descrição

nsclc, locally advanced, not suitable for surgery and radiotherapy is not indicated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0677984
UMLS CUI [1,3]
C0920424
UMLS CUI [1,4]
C1522449
neither cytostatic nor immunological pre-treatment
Descrição

prior chemotherapy, prior immunotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C1514461
age >70 years
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
at least one measurable lesion (recist criteria) that was not previously irradiated
Descrição

measurable lesion, not previously irradiated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C0279134
ecog performance status 0-1
Descrição

ecog

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 3 month
Descrição

life expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
adequate bone marrow function: anc > 1.5 x 109/l, platelets > 100 x 109/l
Descrição

anc, platelets

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
adequate liver function: total bilirubin < 1.5 x uln, got/gpt< 3 x uln (existent liver metastases < 5 x uln)
Descrição

bilirubin, got, gpt

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
adequate renal function:creatinine clearance > 45 ml/min (calculated according to cockroft-gault)
Descrição

creatinine clearance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0373595
fertile men must agree to use an effective method of birth control while participating in this study
Descrição

gender, fertility, contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0015895
UMLS CUI [1,3]
C0700589
signed written informed consent
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled metastasis in the cns
Descrição

cns metastasis, uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205318
acute, heavy uncontrolled infection
Descrição

infection, uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0275518
UMLS CUI [1,2]
C0205318
any other serious concomitant disease or medical condition, which could interfere with participating in this study
Descrição

severe comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
severe hypersensitivity to erlotinib or any other component
Descrição

hypersensitivity erlotinib

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1135135
hypersensitivity to carboplatin and/or other platinum compounds
Descrição

hypersensitivity carboplatin and/or other platinum compounds

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0079083
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C3536919
hypersensitivity to vinorelbin or other vinca-alkaloids
Descrição

hypersensitivity to vinorelbin or other vinca-alkaloids

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0078257
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0042672
patients with a history of other active malignancy in the past 5 years (with the exception of carcinoma in situ of the cervix, non melanomatous skin cancers or local prostate carcinoma that was surgically treated successfully) are excluded.
Descrição

history of malignancy, with exception of carcinoma in situ of the cervix, non melanomatous skin cancers or local prostate carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2735088
UMLS CUI [2]
C0851140
UMLS CUI [3]
C3281209
UMLS CUI [4,1]
C0600139
UMLS CUI [4,2]
C0277565
participation in another clinical trial with any investigational drug at the same time or within 30 days prior to registration
Descrição

study subject participation status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
psychological, familial, social or geographical situations limiting the compliance with the study requirements
Descrição

compliance behaviour

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00678964

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
nsclc, tumor stage
Item
histologically or cytological proven nsclc, stage lll b (with pleural effusion) or stage lv.
boolean
C0007131 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
nsclc, locally advanced, not suitable for surgery and radiotherapy is not indicated
Item
tumor is locally advanced and not suitable for surgery and radiotherapy is not indicated.
boolean
C0007131 (UMLS CUI [1,1])
C0677984 (UMLS CUI [1,2])
C0920424 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
prior chemotherapy, prior immunotherapy
Item
neither cytostatic nor immunological pre-treatment
boolean
C1514457 (UMLS CUI [1])
C1514461 (UMLS CUI [2])
age
Item
age >70 years
boolean
C0001779 (UMLS CUI [1])
measurable lesion, not previously irradiated
Item
at least one measurable lesion (recist criteria) that was not previously irradiated
boolean
C0221198 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0279134 (UMLS CUI [1,3])
ecog
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
life expectancy
Item
life expectancy > 3 month
boolean
C0023671 (UMLS CUI [1])
anc, platelets
Item
adequate bone marrow function: anc > 1.5 x 109/l, platelets > 100 x 109/l
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
bilirubin, got, gpt
Item
adequate liver function: total bilirubin < 1.5 x uln, got/gpt< 3 x uln (existent liver metastases < 5 x uln)
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
creatinine clearance
Item
adequate renal function:creatinine clearance > 45 ml/min (calculated according to cockroft-gault)
boolean
C0373595 (UMLS CUI [1])
gender, fertility, contraceptive methods
Item
fertile men must agree to use an effective method of birth control while participating in this study
boolean
C0079399 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
informed consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
cns metastasis, uncontrolled
Item
uncontrolled metastasis in the cns
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
infection, uncontrolled
Item
acute, heavy uncontrolled infection
boolean
C0275518 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
severe comorbidity
Item
any other serious concomitant disease or medical condition, which could interfere with participating in this study
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
hypersensitivity erlotinib
Item
severe hypersensitivity to erlotinib or any other component
boolean
C0020517 (UMLS CUI [1,1])
C1135135 (UMLS CUI [1,2])
hypersensitivity carboplatin and/or other platinum compounds
Item
hypersensitivity to carboplatin and/or other platinum compounds
boolean
C0020517 (UMLS CUI [1,1])
C0079083 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C3536919 (UMLS CUI [2,2])
hypersensitivity to vinorelbin or other vinca-alkaloids
Item
hypersensitivity to vinorelbin or other vinca-alkaloids
boolean
C0020517 (UMLS CUI [1,1])
C0078257 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0042672 (UMLS CUI [2,2])
history of malignancy, with exception of carcinoma in situ of the cervix, non melanomatous skin cancers or local prostate carcinoma
Item
patients with a history of other active malignancy in the past 5 years (with the exception of carcinoma in situ of the cervix, non melanomatous skin cancers or local prostate carcinoma that was surgically treated successfully) are excluded.
boolean
C2735088 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
C3281209 (UMLS CUI [3])
C0600139 (UMLS CUI [4,1])
C0277565 (UMLS CUI [4,2])
study subject participation status
Item
participation in another clinical trial with any investigational drug at the same time or within 30 days prior to registration
boolean
C2348568 (UMLS CUI [1])
compliance behaviour
Item
psychological, familial, social or geographical situations limiting the compliance with the study requirements
boolean
C1321605 (UMLS CUI [1])
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