A phase 2 study of cisplatin/pemetrexed followed by maintenance pemetrexed in patients with stage 3B or 4 non-squamous non-small-cell lung cancer.
- Conditions
- Previously untreated stageIIIB/IV non-squamous non-small-cell lung cancer
- Registration Number
- JPRN-UMIN000002686
- Lead Sponsor
- Kinki-chuo chest medical center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients who were progression free and on treatment at 6 months
- Secondary Outcome Measures
Name Time Method safety,progression free survival,1 year survival rate, response rate