ID

13776

Beschreibung

A Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Cancer Who Present Epidermal Growth Factor Receptor Mutations; ODM derived from: https://clinicaltrials.gov/show/NCT01372384

Link

https://clinicaltrials.gov/show/NCT01372384

Stichworte

Versionen (1)
  1. 06.03.16 06.03.16 -
Hochgeladen am

6. März 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT01372384

Englisch

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT01372384

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 years of age
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
locally advanced (stage iiib), metastatic (stage iv) or recurrent non-small cell lung cancer with mutations in the tyrosine kinase domain of the epidermal growth factor receptor (egfr)
Beschreibung

non-small cell lung cancer; Tyrosine kinase mutation; epidermal growth factor receptor

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C3267004
UMLS CUI [3]
C0034802
at least one measurable lesion according to recist criteria
Beschreibung

lesion

Datentyp

boolean

Alias
UMLS CUI [1]
C0221198
european cooperative oncology group (ecog) performance status 0-2
Beschreibung

ecog

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematological, liver and renal function
Beschreibung

liver function; renal function; Hematologic function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0221130
patients with stable cerebral metastases who have received surgical or radiotherapy will be eligible
Beschreibung

Cerebral metastasis; radiotherapy; surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0555278
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0543467
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous chemotherapy or therapy against egfr for metastatic disease (neoadjuvant or adjuvant therapy after radical surgery is allowed if finalized >/= 6 months before entering the study)
Beschreibung

chemotherapy; therapy egfr; Neoadjuvant Therapy; adjuvant therapy; surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0034802
UMLS CUI [3]
C0600558
UMLS CUI [4]
C0677850
UMLS CUI [5]
C0543467
history of another neoplasm except for carcinoma in situ of the cervix, adequately treated basal cell skin carcinoma, radically treated prostate carcinoma with good prognosis (gleason </= 6), or another curatively treated neoplasm without evidence of disease in the last 5 years
Beschreibung

cervix carcinoma in situ; basal cell skin carcinoma; prostate carcinoma; good prognosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0851140
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0600139
UMLS CUI [4]
C0278250
symptomatic cerebral metastases
Beschreibung

cerebral metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0555278
any significant ophthalmologic abnormality
Beschreibung

Eye Abnormalities

Datentyp

boolean

Alias
UMLS CUI [1]
C0015393
use of coumarins
Beschreibung

Coumarins

Datentyp

boolean

Alias
UMLS CUI [1]
C0010207
pregnant or breast-feeding women
Beschreibung

pregnancy; lactating

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis and carcinomatosis (if this is the only presence of the disease)
Beschreibung

pulmonary fibrosis; Lymphangiosis carcinomatosa

Datentyp

boolean

Alias
UMLS CUI [1]
C0034069
UMLS CUI [2]
C0948588
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Ähnliche Modelle

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT01372384

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
adult patients, >/= 18 years of age
boolean
C0001779 (UMLS CUI [1])
non-small cell lung cancer; Tyrosine kinase mutation; epidermal growth factor receptor
Item
locally advanced (stage iiib), metastatic (stage iv) or recurrent non-small cell lung cancer with mutations in the tyrosine kinase domain of the epidermal growth factor receptor (egfr)
boolean
C0007131 (UMLS CUI [1])
C3267004 (UMLS CUI [2])
C0034802 (UMLS CUI [3])
lesion
Item
at least one measurable lesion according to recist criteria
boolean
C0221198 (UMLS CUI [1])
ecog
Item
european cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
liver function; renal function; Hematologic function
Item
adequate hematological, liver and renal function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0221130 (UMLS CUI [3])
Cerebral metastasis; radiotherapy; surgery
Item
patients with stable cerebral metastases who have received surgical or radiotherapy will be eligible
boolean
C0555278 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
chemotherapy; therapy egfr; Neoadjuvant Therapy; adjuvant therapy; surgery
Item
previous chemotherapy or therapy against egfr for metastatic disease (neoadjuvant or adjuvant therapy after radical surgery is allowed if finalized >/= 6 months before entering the study)
boolean
C0392920 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0034802 (UMLS CUI [2,2])
C0600558 (UMLS CUI [3])
C0677850 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
cervix carcinoma in situ; basal cell skin carcinoma; prostate carcinoma; good prognosis
Item
history of another neoplasm except for carcinoma in situ of the cervix, adequately treated basal cell skin carcinoma, radically treated prostate carcinoma with good prognosis (gleason </= 6), or another curatively treated neoplasm without evidence of disease in the last 5 years
boolean
C0851140 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0600139 (UMLS CUI [3])
C0278250 (UMLS CUI [4])
cerebral metastasis
Item
symptomatic cerebral metastases
boolean
C0555278 (UMLS CUI [1])
Eye Abnormalities
Item
any significant ophthalmologic abnormality
boolean
C0015393 (UMLS CUI [1])
Coumarins
Item
use of coumarins
boolean
C0010207 (UMLS CUI [1])
pregnancy; lactating
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
pulmonary fibrosis; Lymphangiosis carcinomatosa
Item
pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis and carcinomatosis (if this is the only presence of the disease)
boolean
C0034069 (UMLS CUI [1])
C0948588 (UMLS CUI [2])
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