Eligibility Non-small Cell Lung Cancer NCT00694603

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StudyEvent: Eligibility
1. Eligibility Non-small Cell Lung Cancer NCT00694603

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

nsclc stage

Item

pathologically confirmed stage iiib or iv recurrent or progressive nsclc

boolean

C0007131 (UMLS CUI [1,1])
C0178759 (UMLS CUI [1,2])

disease progression while egfr tyrosine kinase inhibitor

Item

patients must have progressed while receiving treatment with a tyrosine kinase inhibitor targeting the egfr pathway

boolean

C0242656 (UMLS CUI [1,1])
C1443775 (UMLS CUI [1,2])

recist criteria

Item

measurable disease, as defined by recist criteria

boolean

C1709926 (UMLS CUI [1])

egfr mutational status

Item

patients must have a suitable frozen or paraffin-embedded tissue sample available for egfr mutational analysis. prior egfr mutational analyses are allowable

boolean

C3266973 (UMLS CUI [1])

asymptomatic brain metastasis, radiotherapy

Item

patients with asymptomatic brain metastasis are eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and be clinically stable

boolean

C0220650 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])

ecog

Item

ecog performance status 0-2

boolean

C1520224 (UMLS CUI [1])

age

Item

18 years of age or older

boolean

C0001779 (UMLS CUI [1])

pregnancy test

Item

negative pregnancy test within 7 days of treatment or be categorized as not of child-bearing potential

boolean

C0032976 (UMLS CUI [1])

bone marrow, renal, hepatic function

Item

bone marrow function, renal function, hepatic function as outlined in protocol

boolean

C0005953 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

pregnancy, breast feeding

Item

women who are pregnant of breastfeeding

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

concurrent malignancy

Item

active concurrent malignancy

boolean

C0006826 (UMLS CUI [1])

major surgery

Item

major thoracic or abdominal surgery within 30 days prior to the first infusion of cetuximab

boolean

C0679637 (UMLS CUI [1])

cardiac disease

Item

significant history of uncontrolled cardiac disease

boolean

C0018799 (UMLS CUI [1])

seizure disorder, neurological disease

Item

uncontrolled seizure disorder, or active neurological disease

boolean

C0014544 (UMLS CUI [1])
C0027765 (UMLS CUI [2])

monoclonal antibodies adverse event

Item

prior severe infusion reactions to a monoclonal antibody

boolean

C0003250 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])

chemotherapy

Item

prior chemotherapy regimen within 21 days prior to study entry

boolean

C0392920 (UMLS CUI [1])

egfr tyrosine kinase inhibitors

Item

any egfr tyrosine kinase inhibitor within 14 days of study entry

boolean

C1443775 (UMLS CUI [1])

radiotherapy

Item

radiation therapy within 14 days prior to the first infusion of cetuximab

boolean

C1522449 (UMLS CUI [1])

acute hepatitis, hiv

Item

acute hepatitis or known hiv

boolean

C0267797 (UMLS CUI [1])
C0019682 (UMLS CUI [2])

infection

Item

active or uncontrolled infection

boolean

C0009450 (UMLS CUI [1])

concurrent chemotherapy, investigational agents

Item

any concurrent chemotherapy or any other investigational agent(s)

boolean

C0392920 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])

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Eligibility Non-small Cell Lung Cancer NCT00694603