ID

22436

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00678964

Nyckelord

Versioner (1)
  1. 2017-06-04 2017-06-04 -
Uppladdad den

4 juni 2017

DOI

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Licens

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

Engelsk

Eligibility Non-Small Cell Lung Cancer NCT00678964

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

nsclc, tumor stage

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

prior chemotherapy, prior immunotherapy

Datatyp

boolean

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

age

Datatyp

boolean

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

measurable lesion, not previously irradiated

Datatyp

boolean

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

ecog

Datatyp

boolean

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

life expectancy

Datatyp

boolean

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

anc, platelets

Datatyp

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)
Beskrivning

bilirubin, got, gpt

Datatyp

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)
Beskrivning

creatinine clearance

Datatyp

boolean

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

gender, fertility, contraceptive methods

Datatyp

boolean

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

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled metastasis in the cns
Beskrivning

cns metastasis, uncontrolled

Datatyp

boolean

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

infection, uncontrolled

Datatyp

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
Beskrivning

severe comorbidity

Datatyp

boolean

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

hypersensitivity erlotinib

Datatyp

boolean

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

hypersensitivity carboplatin and/or other platinum compounds

Datatyp

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
Beskrivning

hypersensitivity to vinorelbin or other vinca-alkaloids

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

study subject participation status

Datatyp

boolean

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

compliance behaviour

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00678964

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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