Non-Small Cell Lung Carcinoma unresectable TNM clinical staging | Primary tumor Symptomatic | Cough | Dyspnea | Pain | Lesion Rapidly progressive Absent
Item
1. unresectable non-small cell lung cancer, stage iiia/b, or stage iv for which the primary tumor is symptomatic (cough, dyspnea, pain) without extra-thoracic lesions rapidly evolving for which patients should receive radiotherapy at curative dose
boolean
C0007131 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0677930 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0010200 (UMLS CUI [3])
C0013404 (UMLS CUI [4])
C0030193 (UMLS CUI [5])
C0221198 (UMLS CUI [6,1])
C1838681 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Measurable lesion | Access During Fiberoptic bronchoscopy
Item
2. measurable lesion, documented histologically, potentially accessible during fiberoptic bronchoscopy.
boolean
C1513041 (UMLS CUI [1])
C0444454 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0189391 (UMLS CUI [2,3])
Age | WHO performance status scale
Item
3. age > 18 years, who 0-1,
boolean
C0001779 (UMLS CUI [1])
C1298650 (UMLS CUI [2])
Neutrophil count | Hemoglobin measurement | Platelet Count measurement
Item
4. neutrophil count > 1500 /mm3, hemoglobin > 9 g/dl, platelet count > 100,000/mm3
boolean
C0200633 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Serum total bilirubin measurement | Transaminase Assay | Albumin measurement | Prothrombin time assay
Item
5. bilirubin < 1.5 mg/dl, transaminases < 3 n, albumin >30 g / l, pt > 70%
boolean
C1278039 (UMLS CUI [1])
C0919834 (UMLS CUI [2])
C0201838 (UMLS CUI [3])
C0033707 (UMLS CUI [4])
Creatinine measurement, serum
Item
6. creatinine < 120 μm/l
boolean
C0201976 (UMLS CUI [1])
Patient Information | Informed Consent
Item
7. patient information and informed consent form signed.
boolean
C1955348 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Prior Therapy Absent Malignant neoplasm of lung | Operative Surgical Procedures Absent | Therapeutic radiology procedure Absent | Chemotherapy Absent
Item
8. no previous treatment for lung cancer (surgery, radiotherapy, chemotherapy).
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0242379 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
RAD 001 | everolimus | mTOR Inhibitor
Item
1. patients previously treated with rad001 (everolimus) or any other mtor inhibitor
boolean
C0962969 (UMLS CUI [1])
C0541315 (UMLS CUI [2])
C2746052 (UMLS CUI [3])
TNM clinical staging | Primary tumor Asymptomatic | Lesion Rapidly progressive Requirement Systemic therapy
Item
2. stage iv for which the primary tumor is not symptomatic with extra-thoracic lesions rapidly evolving requiring systemic treatment
boolean
C3258246 (UMLS CUI [1])
C0677930 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C1838681 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
C1515119 (UMLS CUI [3,4])
Prior radiation therapy
Item
3. previous radiotherapy,
boolean
C0279134 (UMLS CUI [1])
Venous Thrombosis | Arterial thrombosis | Pulmonary Embolism
Item
4. venous or arterial thrombosis, pulmonary embolism during the previous six months
boolean
C0042487 (UMLS CUI [1])
C0151942 (UMLS CUI [2])
C0034065 (UMLS CUI [3])
Phenytoin | Phenobarbital | Antiepileptic Agents | Epilepsy
Item
5. concomitant treatment with phenytoin, phenobarbital or any other antiepileptic agent, history of epilepsy
boolean
C0031507 (UMLS CUI [1])
C0031412 (UMLS CUI [2])
C0003299 (UMLS CUI [3])
C0014544 (UMLS CUI [4])
CYP3A4 Inhibitor | CYP3A4 Inducer | CYP3A4 Substrate | Atazanavir | Clarithromycin | Indinavir | Itraconazole | Ketoconazole | nefazodone | Nelfinavir | Ritonavir | Saquinavir | telithromycin | Amprenavir | aprepitant | Diltiazem | Erythromycin | Fluconazole | fosamprenavir | Verapamil | Cyclosporine | voriconazole | Rifampin | Carbamazepine | Rifabutin | Midazolam | Buspirone | Felodipine
Item
6. concomitant treatment with medicinal products that inhibit, induce or are substrates for cyp3a4(inhibitors: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, ciclosporin, voriconazoleinducers: rifampicin, carbamazepine, rifabutinsubstrates: midazolam, buspirone, felodipine)
boolean
C3830624 (UMLS CUI [1])
C3830625 (UMLS CUI [2])
C3714798 (UMLS CUI [3,1])
C3891814 (UMLS CUI [3,2])
C1145759 (UMLS CUI [4])
C0055856 (UMLS CUI [5])
C0376637 (UMLS CUI [6])
C0064113 (UMLS CUI [7])
C0022625 (UMLS CUI [8])
C0068485 (UMLS CUI [9])
C0525005 (UMLS CUI [10])
C0292818 (UMLS CUI [11])
C0286738 (UMLS CUI [12])
C0907410 (UMLS CUI [13])
C0754188 (UMLS CUI [14])
C1176306 (UMLS CUI [15])
C0012373 (UMLS CUI [16])
C0014806 (UMLS CUI [17])
C0016277 (UMLS CUI [18])
C1176315 (UMLS CUI [19])
C0042523 (UMLS CUI [20])
C0010592 (UMLS CUI [21])
C0393080 (UMLS CUI [22])
C0035608 (UMLS CUI [23])
C0006949 (UMLS CUI [24])
C0140575 (UMLS CUI [25])
C0026056 (UMLS CUI [26])
C0006462 (UMLS CUI [27])
C0015772 (UMLS CUI [28])
Pharmaceutical Preparations Cancer treatment | Methotrexate Rheumatoid Arthritis
Item
7. concomitant therapy with agents otherwise used in the treatment of cancer (for example methotrexate for rheumatoid arthritis).
boolean
C0013227 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Adrenal Cortex Hormones chronic | Immunosuppressive Agents chronic
Item
8. chronic treatment with corticosteroids or another immunosuppressant
boolean
C0001617 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Bleeding tendency | Vitamin K Antagonist Oral | Exception Coumadin Low dose | Exception Warfarin Sodium Low dose
Item
9. patients with an active bleeding diathesis or taking an oral vitamin k antagonist (except low-dose coumadin (warfarin sodium))
boolean
C1458140 (UMLS CUI [1])
C2267235 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699129 (UMLS CUI [3,2])
C0445550 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0376218 (UMLS CUI [4,2])
C0445550 (UMLS CUI [4,3])
Disease Severe compromises Study Subject Participation Status | Disease Uncontrolled compromises Study Subject Participation Status | Diabetic - poor control | Uncontrolled hypertension | Communicable Disease Severe | Severe malnutrition | Angina, Unstable | Congestive heart failure New York Heart Association Classification
Item
10. other concurrent severe and/or uncontrolled disease which could compromise participation in the study (i.e. uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure -
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0421258 (UMLS CUI [3])
C1868885 (UMLS CUI [4])
C0009450 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0311276 (UMLS CUI [6])
C0002965 (UMLS CUI [7])
C0018802 (UMLS CUI [8,1])
C1275491 (UMLS CUI [8,2])
Ventricular arrhythmia | Myocardial Ischemia | Myocardial Infarction | Chronic liver disease | Kidney Failure, Chronic | Upper Gastrointestinal Tract Ulceration
Item
new york heart association class iii or iv, ventricular arrhythmia, active ischemic heart disease, myocardial infarction during the previous six months, chronic liver or renal disease, active upper gi tract ulceration)
boolean
C0085612 (UMLS CUI [1])
C0151744 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0341439 (UMLS CUI [4])
C0022661 (UMLS CUI [5])
C3203348 (UMLS CUI [6,1])
C3887532 (UMLS CUI [6,2])
Abnormal digestive tract function Changing Absorption RAD 001 | Gastrointestinal Diseases Changing Absorption RAD 001 | Abnormal digestive tract function Changing Absorption Everolimus | Gastrointestinal Diseases Changing Absorption Everolimus | Ulcer | Nausea Uncontrolled | Vomiting | Diarrhea | Malabsorption Syndrome | Small intestine excision
Item
11. impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of rad001 (everolimus) (i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
boolean
C0232459 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0962969 (UMLS CUI [1,4])
C0017178 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0962969 (UMLS CUI [2,4])
C0232459 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0237442 (UMLS CUI [3,3])
C0541315 (UMLS CUI [3,4])
C0017178 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C0237442 (UMLS CUI [4,3])
C0541315 (UMLS CUI [4,4])
C0041582 (UMLS CUI [5])
C0027497 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0042963 (UMLS CUI [7])
C0011991 (UMLS CUI [8])
C0024523 (UMLS CUI [9])
C0192601 (UMLS CUI [10])
HIV Seropositivity
Item
12. hiv seropositivity
boolean
C0019699 (UMLS CUI [1])
Hepatitis B virus test positive | Hepatitis B virus surface Positive
Item
13. patient with a virological test positive to hepatitis b (hbs positive)
boolean
C2748184 (UMLS CUI [1])
C1440684 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Dermatologic disorders Grade | Disease of mucous membrane Grade | Disorder of eye Grade | Gastrointestinal Diseases Grade
Item
14. patients with active cutaneous, mucosal, ocular or gastrointestinal disorders of grade > 1
boolean
C0037274 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0151785 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C0015397 (UMLS CUI [3,1])
C0441800 (UMLS CUI [3,2])
C0017178 (UMLS CUI [4,1])
C0441800 (UMLS CUI [4,2])
Malignant Neoplasms Previous | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
15. previous cancer (except basal cell skin cancer or cervical carcinoma in situ) during the 3 years prior to entering the trial.
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Pulmonary Fibrosis Radiography
Item
16. important pulmonary fibrosis on x-ray
boolean
C0034069 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
Pregnancy | Pregnancy Possible | Breast Feeding
Item
17. women who are or could become pregnant or who are currently breastfeeding,
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])