Non-squamous non-small cell lung cancer
Item
1. histological confirmation of non-squamous nsclc
boolean
C4324656 (UMLS CUI [1])
Availability of Biopsy tissue | Determination ERCC1 Status
Item
2. have a tissue biopsy available for sending to the central laboratory to determine ercc1 status
boolean
C0470187 (UMLS CUI [1,1])
C3864006 (UMLS CUI [1,2])
C0521095 (UMLS CUI [2,1])
C1333355 (UMLS CUI [2,2])
C0449438 (UMLS CUI [2,3])
Disease TNM clinical staging | Disease Inappropriate Curative treatment
Item
3. presentation with stage iiib (not amenable to curative treatment) or iv disease -
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1273390 (UMLS CUI [2,3])
TNM clinical staging Recent | Non-small cell lung cancer recurrent Prior Chemotherapy Absent | Non-small cell lung cancer recurrent Biological treatment Absent
Item
staging scans must be no more than 28 days prior to registration. patients with relapsed nsclc must not have received prior chemotherapy or biological therapy (previous surgery or radical radiotherapy allowed)
boolean
C3258246 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0278517 (UMLS CUI [2,1])
C1514457 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0278517 (UMLS CUI [3,1])
C1531518 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Measurable lesion Quantity
Item
4. at least one measurable lesion according to response evaluation criteria in solid tumours
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Age
Item
5. either sex, at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
6. ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
7. estimated life expectancy of at least 8 weeks
boolean
C0023671 (UMLS CUI [1])
Bone Marrow function
Item
8. adequate bone marrow function as evidenced by the following (assessed within 14 days of registration):
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
Absolute neutrophil count
Item
absolute neutrophil count (anc) ≥1.5 × 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥100 × 109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
haemoglobin ≥9 g/dl
boolean
C0518015 (UMLS CUI [1])
Liver function
Item
9. adequate liver function as evidenced by the following (assessed within 14 days of registration):
boolean
C0232741 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin ≤ 1.5 x upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver
Item
aspartate transaminase (ast) ≤3 × uln or ≤5 × uln is acceptable with liver metastases
boolean
C0201899 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
Alanine aminotransferase measurement
Item
alanine transaminase (alt) ≤3 × uln
boolean
C0201836 (UMLS CUI [1])
Renal function
Item
10. adequate renal function as evidenced by the following (assessed within 14 days of registration):
boolean
C0232804 (UMLS CUI [1])
Glomerular Filtration Rate | Creatinine clearance measurement EDTA | Glomerular Filtration Rate Cockcroft-Gault formula
Item
gfr > 60ml/min as measured by creatinine clearance through edta. alternatively, the cockcroft and gault formula may be used to estimate gfr, but if < 60 ml/min then edta should be performed.
boolean
C0017654 (UMLS CUI [1])
C0373595 (UMLS CUI [2,1])
C0013618 (UMLS CUI [2,2])
C0017654 (UMLS CUI [3,1])
C2924627 (UMLS CUI [3,2])
Palliative course of radiotherapy Metastatic Lesion
Item
11. previous palliative radiotherapy to non-target metastatic lesions is allowed for pain relief prior to starting chemotherapy
boolean
C0475092 (UMLS CUI [1,1])
C1513183 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Stable | Disease Progression Absent CT scan | Disease Progression Absent MRI
Item
12. patients with stable brain metastases will be allowed to enrol. stable brain metastases being defined as no progression of brain metastases 28 days after treatment as documented by a ct scan/mri of the brain. patients with incidentally discovered asymptomatic brain metastases may be enrolled and treated with trial chemotherapy without prior brain irradiation if deemed feasible by the treating physician
boolean
C0220650 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C0242656 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
Informed Consent
Item
13. signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods | Partner Reproductive potential Contraceptive methods | Aprepitant Contraceptive methods Alternative | Childbearing Potential Serum pregnancy test negative
Item
14. use of effective contraception during, and for 6 months after trial treatment by patients of reproductive potential and partners of reproductive potential. patients who receive aprepitant (anti-emetic) must be willing to use an alternative or back-up method to hormonal contraceptives as aprepitant may reduce their efficacy. female patients with childbearing potential must have a negative serum pregnancy test prior to registration.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0682323 (UMLS CUI [2,1])
C4034483 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C1176306 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1523987 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0430061 (UMLS CUI [4,2])
Non-Small Cell Lung Carcinoma Cytology
Item
1. cytologically or clinically diagnosed nsclc
boolean
C0007131 (UMLS CUI [1,1])
C0010818 (UMLS CUI [1,2])
Medical condition Study Subject Participation Status Unfavorable | Laboratory test finding Study Subject Participation Status Unfavorable
Item
2. evidence of significant medical condition or laboratory finding which, in the opinion of the treating physician or chief investigator, makes it undesirable for the patient to participate in the trial
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
Metastatic malignant neoplasm to brain Uncontrolled | Metastatic Malignant Neoplasm to the Leptomeninges Uncontrolled | Therapeutic radiology procedure Required
Item
3. presence of uncontrolled brain or leptomeningeal metastases thought to require immediate radiotherapy
boolean
C0220650 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1704231 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Body Fluids Space Third | Ascites | Pleural effusion | Control Unsuccessful
Item
4. presence of clinically significant third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to trial entry
boolean
C0005889 (UMLS CUI [1,1])
C1883067 (UMLS CUI [1,2])
C0205437 (UMLS CUI [1,3])
C0003962 (UMLS CUI [2])
C0032227 (UMLS CUI [3])
C2587213 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
Vaccination against yellow fever
Item
5. yellow fever vaccination received within the 30 days previous to study entry
boolean
C0199823 (UMLS CUI [1])
Aspirin Discontinue Unable | NSAIDs Discontinue Unable
Item
6. unable to interrupt aspirin or other nsaids (for pemetrexed arms of the trial)
boolean
C0004057 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Intake Vitamin B12 Unable | Intake Folic acid Unable | Intake Vitamin B12 Unwilling | Intake Folic acid Unwilling
Item
7. unable or unwilling to take vitamin b12 and folic acid (for pemetrexed arms of the trial)
boolean
C1512806 (UMLS CUI [1,1])
C0042845 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1512806 (UMLS CUI [2,1])
C0016410 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C1512806 (UMLS CUI [3,1])
C0042845 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C1512806 (UMLS CUI [4,1])
C0016410 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Malignant Neoplasm | Exception Disease Free Duration | Exception Skin carcinoma | Exception Cervical cancer Early
Item
8. a history of prior malignant tumour, unless the patient has been without evidence of disease for at least 3 years or the tumour was a non-melanoma skin tumour or early cervical cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C4048328 (UMLS CUI [4,2])
C1279919 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
9. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Protocol Compliance Unable
Item
10. inability to comply with protocol or trial procedures
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])