over 20 years old patients in previously untreated patients stage III/IV or recurrent post-opetative non-small-cell and non-squamous lung cancer.
Conditions
Interventions
Four cycles of Pemetrexed + Cisplatin followed by maintenance Pemetrexed in 21-day cycles until progression disease
Sponsors
Department of respiratory medicine,Osala university Hospital.
OULCSG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed non-sqamous and non-small-cell lung cancer with Chemo naive patients (Radiothrapy to any place other than primary and evaluable lesion is competent) 2)Patients who have measurable lesion (In 10mm Slice CT more than 20mm, in 5mm Slice CT more than 10mm) or evaluable lesion by RECIST 3)Stage III/IV without any indications for radiotherapy, or recurrent disease after surgery that passes more than one year from the last dosage day of adjuvant chemotherapy 5)Patients aged 20 years or older 6)ECOG 0-1 7)Adequate organ function, evaluated within 14 days before enrollment (registration day is day1, and on the same day two weeks ago, is impossible) as WBC >= 4,000/mm3 Neu >= 2,000/mm3 Plt >= 100,000/mm3 Hb >= 9.5 g/dL over AST/ALT, 3 of upper limit of normal or less. T.Bil under 1.5 g/dL Ccr >= 60mL/min, sCr:x1.2 of upper limit of normal or less. SpO2 over 93% as room air 8)Patients are excepted to live over 3 months after administration day 9)Written informed consent from the patients
Exclusion criteria
Exclusion criteria: 1)Patients have diagnosed squamous cell carcinoma 2)Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray 3) Patiens has pleural effusion, pericardial effusion and ascites to need treatment for 4) Patients unable to administer folic acid and vitamin B12, or not 5) Severe renal function disorder 6) Pregnancy, breast feeding and suspected pregnancy 7) SVC syndrome 8) Active double cancer 9) Uncontrollable diabetes mellitus and hypertenson 10) Diagnosed as liver cirrhosis by image findings or clinical laboratory 11) History of severe heart disease (uncontrollable arrythmia, uncontrollable angina pectoris, congestive heart failue, etc within 6 months) 12) Pregnancy, breast feeding and suspected pregnancy 13) Grave drug allergic reaction 14) Acute inflammatory disease 15) An agreement is not obtained for support therapy such as transfusion etc 16) Having the bleeding tendency which is clear in clinic 17) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One year survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival, Evaluation of safety, Response rate, overall survival | — |
Countries
Japan
Contacts
Public ContactTakashi Kijima
Osaka university Hosipital department of respiratory medicine
Outcome results
None listed