Informações:
Falhas:
ID
22139
Descrição
Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00466284
Link
https://clinicaltrials.gov/show/NCT00466284
Palavras-chave
Versões (1)
- 21/05/2017 21/05/2017 -
Transferido a
21 de maio de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00466284
Eligibility Non-Small Cell Lung Cancer NCT00466284
- StudyEvent: Eligibility
Similar models
Eligibility Non-Small Cell Lung Cancer NCT00466284
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
age 18 years.
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma unresectable TNM clinical staging
Item
patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage ia- iiib).
boolean
C0007131 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C1519810 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Measurable Disease
Item
measurable disease.
boolean
C1513041 (UMLS CUI [1])
Informed Consent
Item
written informed consent must be obtained prior to the inclusion into the trial.
boolean
C0021430 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance status of 80%.
boolean
C0206065 (UMLS CUI [1])
Prior Chemotherapy Absent | Prior radiation therapy Absent
Item
patients must have been treated with no prior chemotherapy or radioterapy.
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0332197 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Bone Marrow function | Liver function | Renal function
Item
patients must have adequate bone marrow, liver and renal function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Bone Marrow function | White Blood Cell Count procedure
Item
bone marrow: wbc > 3000 x 103/mm3,
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0023508 (UMLS CUI [2])
C0031843 (UMLS CUI [1,2])
C0023508 (UMLS CUI [2])
Platelet Count measurement
Item
platelets > 100 x 103/mm3,
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hgb > 10.0 gm/dl,
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
anc >1500 x 103/mm3,
boolean
C0948762 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
hepatic:bilirubin < 2 mg/dl (34 µmol/l); ast, alt, and alkaline phosphatase < 5 x normal,
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
Renal function | Creatinine measurement, serum
Item
renal:creatinine < 1.5 mg/dl (132 µmol/l).
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0201976 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
female patients who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
patients who have used other investigational agents within 21 days prior to study entry.
boolean
C0013230 (UMLS CUI [1])
erlotinib | Epidermal growth factor receptor inhibitor
Item
patients who have received prior treatment with erlotinib or other anti-egfr agent.
boolean
C1135135 (UMLS CUI [1])
C1443775 (UMLS CUI [2])
C1443775 (UMLS CUI [2])
Comorbidity Significant
Item
significant comorbidity.
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,2])