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)

Type de données

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