Eligibility Non-small Cell Lung Cancer NCT00885963

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StudyEvent: Eligibility
1. Eligibility Non-small Cell Lung Cancer NCT00885963

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Non-small cell lung cancer recurrent

Item

histologically or cytologically confirmed recurrent nsclc

boolean

C0278517 (UMLS CUI [1])

Age

Item

age of 18 years or older

boolean

C0001779 (UMLS CUI [1])

ECOG performance status

Item

eastern cooperative oncology group (ecog) performance status 0-2

boolean

C1520224 (UMLS CUI [1])

Measurable Disease

Item

measurable disease according to recist

boolean

C1513041 (UMLS CUI [1])

Prior Chemotherapy Quantity Neoplasm Metastasis | Prior Chemotherapy Quantity Recurrent disease

Item

had only 1 prior chemotherapy regimen for metastatic or recurrent disease; patients who have received more than one prior chemotherapy regimens may participate in part a of the study only.

boolean

C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0277556 (UMLS CUI [2,3])

Bone Marrow function

Item

adequate bone marrow function

boolean

C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])

Renal function

Item

adequate renal function

boolean

C0232804 (UMLS CUI [1])

Liver function

Item

adequate liver function

boolean

C0232741 (UMLS CUI [1])

Systemic therapy Previous | Cancer treatment Investigational Previous | Prior radiation therapy | Toxicity Previous Patient recovered

Item

at least 3 weeks from prior systemic treatments including investigational anti-cancer therapy; at least 7 days from prior radiation therapy; and have recovered from prior toxicities

boolean

C1515119 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C0279134 (UMLS CUI [3])
C0600688 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C1115804 (UMLS CUI [4,3])

Major surgery

Item

at least 3 weeks from major surgery

boolean

C0679637 (UMLS CUI [1])

Able to swallow Capsules

Item

patient must be able to swallow capsules

boolean

C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])

Contraceptive methods | Exception Infertility Documented

Item

agree to practice effective contraception during the entire study period and for one month after being discontinued from the study unless documentation of infertility exists. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

boolean

C0700589 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021359 (UMLS CUI [2,2])
C1301725 (UMLS CUI [2,3])

Informed Consent

Item

ability to understand and willingness to sign the informed consent form

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Non-Small Cell Lung Carcinoma Histology Containing Component Small cell carcinoma of lung

Item

nsclc histology contains a component of small cell lung cancer

boolean

C0007131 (UMLS CUI [1,1])
C4048239 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C1705248 (UMLS CUI [1,4])
C0149925 (UMLS CUI [1,5])

CNS metastases untreated | CNS metastases Progressive MRI scan

Item

previously untreated cns metastasis or progressive cns metastasis documented by mri scan performed at 4 weeks or longer after the last treatment for cns metastasis

boolean

C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])

Therapeutic radiology procedure | Biological treatment | Investigational New Drugs

Item

currently receiving radiotherapy, biological therapy, or any other investigational agents

boolean

C1522449 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0013230 (UMLS CUI [3])

Item

uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

boolean

C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])

Item

cancer other than nsclc that has been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer, and basal or squamous cell skin cancer; patients who received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 5 years may participate in this study

boolean

C0392920 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2,1])
C1707251 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0553723 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C0279025 (UMLS CUI [6,1])
C0600558 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
C0279025 (UMLS CUI [7,1])
C1522673 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])

Pregnancy | Breast Feeding

Item

pregnant or lactating women

boolean

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

HIV Seropositivity

Item

known to be hiv-positive

boolean

C0019699 (UMLS CUI [1])

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Eligibility Non-small Cell Lung Cancer NCT00885963