Chemotherapy Regimen Cisplatin Based | cisplatin/vinorelbine | cisplatin/gemcitabine
Item
recommendation from treating oncologist to receive a cisplatin based chemotherapy regimen, specifically either cisplatin/vinorelbine or cisplatin/gemcitabine
boolean
C0392920 (UMLS CUI [1,1])
C0008838 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
C0281497 (UMLS CUI [2])
C0338265 (UMLS CUI [3])
Age
Item
> or = 18 years of age
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histologically proven diagnosis of non-small cell lung cancer, stage iiib or iv
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
adequate renal function: creatinine < 1.5 mg/dl or < 132 µmol/l and creatinine clearance of > 45 ml/min using the cockcroft-gault formula
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Exception Secondary malignant neoplasm of liver
Item
adequate hepatic function: bilirubin < 1.5 mg/dl or < 25 µmol/l and ast and alt < 2 times upper limit of normal, unless there is evidence of liver metastases, in which case < 5 times upper limit of normal
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0494165 (UMLS CUI [5,2])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
adequate hematological function: absolute neutrophil count (anc) > 1.5 x 109/l and platelets > 100 x 109/l and hemoglobin > 100 g/l
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 - 2
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Females & males of reproductive potential Contraceptive methods Quantity | Exception Sexual Abstinence
Item
negative serum pregnancy test for women of childbearing potential. women and men of child bearing potential must use effective contraception defined as the simultaneous use of two reliable methods unless abstinence is the chosen method.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C4034483 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
Life Expectancy
Item
life expectancy of > 4 months in the opinion of the treating oncologist
boolean
C0023671 (UMLS CUI [1])
Prior radiation therapy | Exception Bone Marrow Percentage | Toxicity Due to Prior radiation therapy | Patient recovered
Item
prior radiotherapy is allowed (unless > 25% of bone marrow stores) if this radiation was > 4 weeks before study entry and patient has fully recovered from toxicity of this treatment
boolean
C0279134 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0005953 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0279134 (UMLS CUI [3,3])
C1115804 (UMLS CUI [4])
Protocol Compliance
Item
willingness to comply with the study protocol
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
ability to give written informed consent with the understanding that it may be withdrawn at any time without prejudice
boolean
C0021430 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Metastatic malignant neoplasm to brain
Item
brain metastases (a ct or mri is not required to rule out brain metastases unless there is clinical suspicion)
boolean
C0220650 (UMLS CUI [1])
Malignant Neoplasms | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Ductal Carcinoma in Situ of Breast | Exception Skin carcinoma | Exception Carcinoma of bladder low grade
Item
previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix, in situ ductal breast cancer, non-melanoma skin cancer or low grade bladder cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0851140 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007124 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0699893 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0699885 (UMLS CUI [5,2])
C1282907 (UMLS CUI [5,3])
Major surgery | Recovery Lacking
Item
patients who have had major surgery within three weeks of enrollment without a full recovery
boolean
C0679637 (UMLS CUI [1])
C2004454 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Cancer treatment Previous
Item
prior treatment with any anticancer therapy
boolean
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
HIV Seropositivity
Item
patients who have tested positive for hiv
boolean
C0019699 (UMLS CUI [1])
Medical condition Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded | Compliance behavior Limited | Patient safety At risk
Item
any significant medical or psychiatric condition that, in the opinion of the investigator, will exclude the patient from the study for compliance or safety reasons
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C1321605 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C1113679 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])