nsclc
Item
1. histologic or cytologic diagnosis of nsclc
boolean
C0007131 (UMLS CUI [1])
nsclc ajcc tumor stage, pleural effusion, multiple lung nodules
Item
2. stage iv or selected stage iiib (with positive pleural effusion or multiple ipsilateral lung nodules) according to the american joint committee on cancer (ajcc).
boolean
C0007131 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
C0441915 (UMLS CUI [1,3])
C0032227 (UMLS CUI [1,4])
C0748164 (UMLS CUI [1,5])
platinum-based chemotherapy
Item
3. previously treated with at least one platinum-based chemotherapy.
boolean
C0392920 (UMLS CUI [1,1])
C3536920 (UMLS CUI [1,2])
prior chemotherapy
Item
4. before study entry, a minimum of 21 days must have elapsed since any prior chemotherapy.
boolean
C1514457 (UMLS CUI [1])
prior radiotherapy
Item
5. prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
boolean
C0279134 (UMLS CUI [1])
other cancer therapy
Item
6. no other forms of cancer therapy, such as radiation, immunotherapy for at least 2 weeks before the enrollment in study.
boolean
C0920425 (UMLS CUI [1])
ecog
Item
7. performance status of 0-3 on the ecog criteria.
boolean
C1520224 (UMLS CUI [1])
response evaluation criteria in solid tumors, life expectancy
Item
8. at least one unidimensional measurable lesion meeting response evaluation criteria in solid tumors (recist. 2000).- estimated life expectancy of at least 8 weeks.
boolean
C1709926 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
follow-up compliance
Item
9. patient compliance that allow adequate follow-up.
boolean
C3274571 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
hematologic, hepatic, renal function
Item
10. adequate hematologic (anc count ≥ 1,000/ul, platelet count ≥ 150,000/mm3), hepatic (bilirubin level≤1.5 mg/dl, ast/alt ≤ 80 iu/l), and renal (creatinine concentration ≤ 1.5 mg/dl) function.
boolean
C0221130 (UMLS CUI [1,1])
C0948762 (UMLS CUI [1,2])
C0005821 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2,1])
C1278039 (UMLS CUI [2,2])
C0201899 (UMLS CUI [2,3])
C0201836 (UMLS CUI [2,4])
C0232804 (UMLS CUI [3,1])
C0201976 (UMLS CUI [3,2])
informed consent
Item
11. informed consent from patient or patient's relative.
boolean
C0021430 (UMLS CUI [1])
age
Item
12. males or females at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
effective contraception, pregnancy test
Item
13. if female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [iud], birth control pills, or barrier device) during and for 3 months after trial. if male, use of an approved contraceptive method during the study and 3 months afterwards. females with childbearing potential must have a urine negative hcg test within 7 days prior to the study enrollment.
boolean
C0700589 (UMLS CUI [1])
C0032976 (UMLS CUI [2])
concomitant medication
Item
14. no concomitant prescriptions including cyclosporin a, valproic acid, phenobarbital, phenytoin, ketoconazole.
boolean
C2347852 (UMLS CUI [1])
brain metastasis neurological symptoms
Item
15. patients with brain metastasis are allowed unless there were clinically significant neurological symptoms or signs
boolean
C0220650 (UMLS CUI [1,1])
C0235031 (UMLS CUI [1,2])
small-cell lung cancer, nsclc cancer therapy toxic effects
Item
1. presence of small-cell lung cancer alone or with nsclc- unresolved chronic toxic effects from previous anticancer therapy
boolean
C0149925 (UMLS CUI [1])
C0007131 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
C0600688 (UMLS CUI [2,3])
gefitinib hypersensitivity
Item
2. known severe hypersensitivity to gefitinib or any of the tablet excipients
boolean
C1122962 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
swallow tablets
Item
3. inability to swallow tablets
boolean
C0566355 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
other malignancy
Item
4. other coexisting malignant disease (apart from basal-cell carcinoma)
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
prior chemotherapy for nsclc
Item
5. more than three previous chemotherapy regimens for nsclc
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
experimental drug egfr inhibitor
Item
6. previous treatment with an experimental agent of which the main mechanism of action is inhibition of epidermal growth factor receptor or its associated tyrosine kinase
boolean
C0304229 (UMLS CUI [1,1])
C1443775 (UMLS CUI [1,2])
phenytoin, carbamazepine, rifampicin, barbiturates, st johns wort, systemic disease, interstitial lung disease, pregnancy, breast feeding
Item
7. concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or st john's wort; severe or uncontrolled systemic disease; clinically active interstitial lung disease (except uncomplicated lymphangitic carcinomatosis) pregnancy; and breastfeeding.
boolean
C0031507 (UMLS CUI [1])
C0006949 (UMLS CUI [2])
C0035608 (UMLS CUI [3])
C0004745 (UMLS CUI [4])
C0936242 (UMLS CUI [5])
C0442893 (UMLS CUI [6])
C0206062 (UMLS CUI [7])
C0032961 (UMLS CUI [8])
C0006147 (UMLS CUI [9])
heart diseases
Item
8. mi within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia
boolean
C0018799 (UMLS CUI [1])
infections
Item
9. serious concomitant infection including post obstructive pneumonia
boolean
C0009450 (UMLS CUI [1])
major surgery
Item
10. major surgery other than biopsy within the past two weeks.
boolean
C0679637 (UMLS CUI [1])
pregnancy, breast feeding
Item
11. pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])