Malignant neoplasm of lung TNM clinical staging
Item
1. histologically or cytologically confirmed stage iiib/iv lung cancer(exclude patients confirmed by sputum cytology)
boolean
C0242379 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Chemotherapy Regimen Quantity
Item
2. received at least one chemotherapy regimen
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Stable Disease CT scan | Gefitinib
Item
3. with stable disease after a month treatment of gefitinib(ct scan)
boolean
C0677946 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C1122962 (UMLS CUI [2])
Therapeutic radiology procedure | Measurable Disease | Palliative therapy
Item
4. the radiotherapy focus is not the measurable disease within 4 weeks.the patients received palliative therapy can be included.
boolean
C1522449 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
C0030231 (UMLS CUI [3])
Age
Item
5. age >18 years, either sex
boolean
C0001779 (UMLS CUI [1])
Measurable Disease | Longest Diameter Spiral CT | Longest Diameter CT
Item
6. with a measurable disease(longest diameters >=10mm with spiral computed tomography (ct)and >=20mm with conventional ct) at least according to recist criteria
boolean
C1513041 (UMLS CUI [1])
C0552406 (UMLS CUI [2,1])
C0860888 (UMLS CUI [2,2])
C0552406 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
WHO performance status scale
Item
7. who performance status(ps)<= 2 ( patients whit ps=2 should not get worsen within 2 weeks before included)
boolean
C1298650 (UMLS CUI [1])
Neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
8. n>=1.5×109/l, plt>=1.5×109/l,hb>=10g/dl
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present | Serum total bilirubin measurement
Item
9. alp<2.5×uln.if alp>=2.5uln, ast&alt should <1.5uln(without liver metastasis) or <5uln(with liver metastasis).tbil<=1.5uln，ast&alt<2.5uln(without liver metastasis) or <5uln (with liver metastasis).
boolean
C0201850 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0494165 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0494165 (UMLS CUI [5,1])
C0150312 (UMLS CUI [5,2])
C1278039 (UMLS CUI [6])
Informed Consent
Item
10. signed and dated informed consent before the start of specific protocol procedures.
boolean
C0021430 (UMLS CUI [1])
Recruitment | Therapeutic procedure | CT scan
Item
11. recruiting and receiving treatment in 5 days after last ct scan
boolean
C0242800 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
Able to swallow Oral medication
Item
12. patients able to taken oral drug
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Life Expectancy | Metastatic malignant neoplasm to brain Asymptomatic allowed | Metastatic malignant neoplasm to brain Treated allowed
Item
1. life expectancy <= 12 weeks.patients with metastatic brain tumors without symptoms or had been treated can be included.
boolean
C0023671 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0220650 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
Anti-egfr monoclonal antibody therapy | Other Coding | erlotinib | cetuximab
Item
2. experience of anti-egfr(the epidermal growth factor receptor) monoclonal antibody or small molecular compounds therapy such as erlotinib or cetuximab.
boolean
C4316122 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
C1135135 (UMLS CUI [3])
C0995188 (UMLS CUI [4])
Lacking Able to swallow Oral medication | Peptic Ulcer Upper gastrointestinal tract Half | Dyspepsia
Item
3. can not take drug orally, have active peptic ulcer,half upper gastrointestinal or have dyspepsia.
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
C0030920 (UMLS CUI [2,1])
C1268997 (UMLS CUI [2,2])
C2825407 (UMLS CUI [2,3])
C0013395 (UMLS CUI [3])
Hypersensitivity Gefitinib
Item
4. allergic to gefitinib
boolean
C0020517 (UMLS CUI [1,1])
C1122962 (UMLS CUI [1,2])
Exposure to Pharmaceutical Preparations Other | Investigational New Drugs Other
Item
5. prior exposure to drugs without approval from this research or other study drugs within 21days before the 1st day taken gefitinib 500mg or 250mg.
boolean
C0332157 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
6. pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Systemic disease Severe Uncontrolled | Respiration Disorders Unstable | Heart Diseases Unstable | Liver diseases Unstable | Kidney Diseases Unstable | Respiration Disorders Uncompensated | Heart Diseases Uncompensated | Liver diseases Uncompensated | Kidney Diseases Uncompensated
Item
7. severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0035204 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0035204 (UMLS CUI [6,1])
C0205433 (UMLS CUI [6,2])
C0018799 (UMLS CUI [7,1])
C0205433 (UMLS CUI [7,2])
C0023895 (UMLS CUI [8,1])
C0205433 (UMLS CUI [8,2])
C0022658 (UMLS CUI [9,1])
C0205433 (UMLS CUI [9,2])
Cancer Other | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma
Item
8. previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except of cervical carcinoma in situ,basal cell carcinoma within 5 years prior to study entry.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])