A Phase II study of Pemetrexed plus split Cisplatin followed by maintenance Pemetrexed in previously untreated patients with stage III/IV or recurrent post-operative non-small-cell with non-squamous lung cancer. OSAKA-LCSG1103
- Conditions
- over 20 years old patients in previously untreated patients stage III/IV or recurrent post-opetative non-small-cell and non-squamous lung cancer.
- Registration Number
- JPRN-UMIN000007986
- Lead Sponsor
- Department of respiratory medicine,Osala university Hospital.
- Brief Summary
Thirty-eight (71.7%) patients completed induction therapy, while 35 (66.0%) received maintenance therapy. The 1-year survival rate was 67.7%. The median PFS and OS were 5.3 and 18.6 months, respectively. The response rate and disease control rate (DCR) during the induction phase were 37.7 and 86.8%, respectively. Eight patients (15.1%) discontinued the therapy due to adverse events (AEs) during the induction phase, but both hematological and non-hematological AEs were infrequent.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 53
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method One year survival
- Secondary Outcome Measures
Name Time Method Progression Free Survival, Evaluation of safety, Response rate, overall survival