Previously untreated stageIIIB/IV non-squamous non-small-cell lung cancer
Conditions
Interventions
Four cycles of cisplatin(75mg/m2)+pemetrexed(500mg/m2) followed by pemetrexed(500mg/m2)in 21-day cycles until disease progression
Sponsors
Kinki-chuo chest medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirned advanced non-squamous non-small-cell lung cancer (NSCLC) 2)With measurable lesion 3)Stage IIIB without any indications for radiotherapy or Stage IV or recurrent disease after surgery or radiotherapy who have no prior chemoterapy 4)less than 74 years old more than 20 years old 5)ECOG PS 0-1 6)Adequate organ function 7)Life expectancy more than 3 months 9)Signed informed consent
Exclusion criteria
Exclusion criteria: 1)Histologically or cytologically confirned squamous cell lung cancer 2)Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray 3) History of poorly controlled pleural effusion,pericardial effusion and ascites 4)Not appropriate to receive the folic acid and vitamin B12 formulation 5)SVC syndrome 6)Symptomatic brain metastases 7)History of active double cancer 8)Uncontrollable diabetes mellitus and hypertension 9)Diagnosed as liver cirrhosis by image findings or clinical laboratory 10)Suffers from an infectious disease to need antibiotic treatment 11)History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,herat failure,etc within 6 months) 12)Pregnant female or sexually active males/females unwilling to use contraception during the protocol treatment 13)History of grave drug allergic reaction 14)Acute inflammatory disease 15)An agreement is not obtained for support therapy such as transfusion etc. 16)History of active psychological disease 17)Having the bleeding tendency which is clear in clinic 18)Taking continuous whole body administration (oral administration or intravenous administration) of steroid 19)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who were progression free and on treatment at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| safety,progression free survival,1 year survival rate, response rate | — |
Countries
Japan
Contacts
Public ContactKazuhiro Asami
Kinki-chuo chest medical center medical oncology
Outcome results
None listed