Non-Small Cell Lung Carcinoma Advanced Local TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging
Item
1. patients with histologically or cytologically confirmed locally advanced (stage iiib) or metastatic (stage iv) nsclc
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])
Adjuvant Chemotherapy Absent | Chemotherapy Palliative Absent
Item
2. no previous adjuvant or palliative chemotherapy
boolean
C0085533 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C1285530 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Therapeutic radiology procedure Absent
Item
3. no previous radiotherapy
boolean
C1522449 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Measurable lesion Linear Quantity
Item
4. presence of at least one unidimensionally measurable lesion (appendix 2)
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
ECOG performance status
Item
5. ecog performance status of 0 or 1 (appendix 3)
boolean
C1520224 (UMLS CUI [1])
Charlson Comorbidity Index
Item
6. charlson score ≤ 2 (appendix 4)
boolean
C3714916 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
7. adequate bone marrow function (absolute neutrophil count ≥ 2 x 109/l, platelet count
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Hemoglobin measurement | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Prothrombin time | Creatinine clearance measurement
Item
≥ 100 x 109/l, and hemoglobin level ≥ 100 g/l), and adequate liver function (bilirubin level < two times the upper limit of normal, ast and/or alt < three times the upper limit of normal, prothrombin time < 1.5 times control), and creatinine clearance ≥ 60 ml/min.
boolean
C0518015 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C1533047 (UMLS CUI [6])
C0373595 (UMLS CUI [7])
CNS metastases Symptomatic Absent | Irradiation of whole brain Cerebral metastasis | Cardiac Arrhythmia Severe | Heart failure Severe | Second degree atrioventricular block | Complete atrioventricular block | Myocardial Infarction
Item
8. absence of symptomatic cns metastases (patients with cerebral metastases treated with brain irradiation may be included), severe cardiac arrhythmia or heart failure, second or third degree heart block or acute myocardial infarction within 4 months prior to study entry.
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C2064932 (UMLS CUI [2,1])
C0555278 (UMLS CUI [2,2])
C0003811 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0018801 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0264906 (UMLS CUI [5])
C0151517 (UMLS CUI [6])
C0027051 (UMLS CUI [7])
Major surgery Absent | Pleurodesis Absent
Item
9. no major surgery or pleurodesis within 14 days prior to enrollment.
boolean
C0679637 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0189557 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Life Expectancy
Item
10. life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Malignant Neoplasms Absent | Skin carcinoma inactive | Carcinoma in situ of uterine cervix inactive | Malignant Neoplasm Disease Free of
Item
11. no previous or concurrent malignancy, except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer if the patient has been disease-free for more than 5 years.
boolean
C0006826 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0699893 (UMLS CUI [2,1])
C0544452 (UMLS CUI [2,2])
C0851140 (UMLS CUI [3,1])
C0544452 (UMLS CUI [3,2])
C0006826 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
Informed Consent
Item
12. written informed consent
boolean
C0021430 (UMLS CUI [1])
Systemic disease Unstable | Communicable Disease | Uncontrolled hypertension | Angina, Unstable | Congestive heart failure | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations | Liver disease | Kidney Disease | Metabolic Diseases
Item
1. any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
boolean
C0442893 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0003811 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C1514873 (UMLS CUI [6,3])
C0013227 (UMLS CUI [6,4])
C0023895 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0025517 (UMLS CUI [9])
Effusion Clinical Significance
Item
2. patients with clinically significant effusions.
boolean
C0013687 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Malignant Neoplasms Affecting Therapy Evaluation
Item
3. any other malignancies within 5 years that could affect therapy evaluation
boolean
C0006826 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1515410 (UMLS CUI [1,3])