Randomized phase II study of pemetrexed plus cisplatin or carboplatin followed by pemetrexed in chemotherapy-naive patients with non-squamous non-small cell lung cancer
- Conditions
- non-squamous non-small cell lung cancer
- Registration Number
- JPRN-UMIN000004876
- Lead Sponsor
- Tokyo Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan. 2)Patients with active co-morbidities including severe conditions. (1)uncontrollable angina pectoris, myocardial infarction within 3 months, severe heart disease. (2)uncontrollable diabetes, hypertension. (3)severe infection (4)paresis of intestine, illeus (5)Patients whose participation in the trial is judged to be inappropriate by the attending doctor. 3)Patients with massive pleural and cardiac effusion and ascites that need to be immediately treated. 4) Brain metastases with neurological symptoms. 5) SVC syndrome. 6) Active double cancer. 7)Pregnancy, breast feeding and suspected pregnancy. 8)History of grave drug allergic reaction. 9) Psychiatric disorder. 10) 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 PFS: progression free survival It verifies that PFS is 4.5 months or more in each arm.
- Secondary Outcome Measures
Name Time Method QOL: quality of life RR: response rate DCR: disease control rate OS: overall survival Maintenance treatment shift rate AE: adverse events