Non-Small Cell Lung Carcinoma Advanced Local TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging | Cytotoxic Chemotherapy Quantity | Platinum-based Drug | Disease Progression
Item
1. histologically or cytologically confirmed nsclc, locally advanced and metastatic disease stage iiib and iv. evidence of disease progression after one or two cytotoxic treatment regimens which should have included a platinum agent.
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0677881 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C2266918 (UMLS CUI [4])
C0242656 (UMLS CUI [5])
Adverse effects Due to Prior Chemotherapy | Complete Recovery CTCAE Grades
Item
2. complete recovery from prior chemotherapy side effects to < grade 2.
boolean
C0879626 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514457 (UMLS CUI [1,3])
C2826210 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Measurable lesion Linear Quantity
Item
3. at least one unidimensional measurable lesion meeting recist criteria.
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
ECOG performance status
Item
4. ecog ps 0-2.
boolean
C1520224 (UMLS CUI [1])
Age
Item
5. age > 18 years.
boolean
C0001779 (UMLS CUI [1])
Organ function
Item
6. adequate organ function, including:
boolean
C0678852 (UMLS CUI [1])
Mature Neutrophils Present Bone Marrow Adequate | Absolute neutrophil count | Platelet Count measurement
Item
adequate bone marrow reserve: anc > 1.5 x 109/l, platelets > 100 x 109/l.
boolean
C1708947 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Involvement with Tumor
Item
hepatic: bilirubin <1.5 x uln, ap, alt, ast < 1.5 x uln ap, alt, and ast <5 x uln is acceptable if the liver has tumor involvement
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0023884 (UMLS CUI [6,1])
C1314939 (UMLS CUI [6,2])
C0027651 (UMLS CUI [6,3])
Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
renal: calculated creatinin clearance > 40 ml/min based on the cockcroft-gault formula.
boolean
C0232804 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Life Expectancy
Item
7. estimated life expectancy >12 weeks.
boolean
C0023671 (UMLS CUI [1])
Reproductive potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative
Item
8. male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
Informed Consent
Item
9. signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Compliance behavior allowing Follow-up | Proximity Geographic allowing Follow-up
Item
10. patient compliance and geographical proximity that allow adequate follow up.
boolean
C1321605 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
C1514583 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C3274571 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
1. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Risk Medical Due to Disease | Communicable Disease Uncontrolled
Item
2. patients with medical risks because of non-malignant disease as well as those with active uncontrolled infection.
boolean
C0035647 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain | Exception Local Therapy Complete CNS metastases | Exception Adrenal Cortex Hormones Discontinued
Item
3. documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrollment.
boolean
C0220650 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1517925 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0686377 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
Epidermal Growth Factor Receptor | pemetrexed | docetaxel
Item
4. previous treatment with an egfr-tki, or in non-squamous histology earlier treatment with pemetrexed and in squamous earlier treatment with docetaxel.
boolean
C0034802 (UMLS CUI [1])
C0210657 (UMLS CUI [2])
C0246415 (UMLS CUI [3])
Aspirin Unable to discontinue | NSAIDs Unable to discontinue | Piroxicam Unable to discontinue
Item
5. inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (5 day period for long-acting agents such as piroxicam).
boolean
C0004057 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2,1])
C1548265 (UMLS CUI [2,2])
C0031990 (UMLS CUI [3,1])
C1548265 (UMLS CUI [3,2])
Folic acid supplementation Intake Unable | Folic acid supplementation Intake Unwilling | Vitamin B12 supplement Intake Unable | Vitamin B12 supplement Intake Unwilling | Dexamethasone Intake Unable | Dexamethasone Intake Unwilling
Item
6. inability or unwillingness to take folic acid, vitamin b-12 supplementation or dexamethasone.
boolean
C0556110 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0556110 (UMLS CUI [2,1])
C1512806 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C3661610 (UMLS CUI [3,1])
C1512806 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C3661610 (UMLS CUI [4,1])
C1512806 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
C0011777 (UMLS CUI [5,1])
C1512806 (UMLS CUI [5,2])
C1299582 (UMLS CUI [5,3])
C0011777 (UMLS CUI [6,1])
C1512806 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])
Investigational New Drugs
Item
7. concomitant treatment with any other experimental drug under investigation.
boolean
C0013230 (UMLS CUI [1])