Randomized phase II trial of Carboplatin plus weekly nab-Paclitaxel versus Cisplatin plus Gemcitabine in patients with chemo-naive stage IIIB/IV or postoperative recurrent squamous cell lung cancer
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000010443
- Lead Sponsor
- orth Japan Lung Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 71
Not provided
1) Previous treatment with gemcitabine and paclitaxel as adjuvant chemotherapy 2) Active double cancer 3) Symptomatic brain metastasis 4) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion 5) Superior vena cava syndrome 6) Grade 2 or higher peripheral neuropathy 7) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis 8) Severe concurrent disease (Ischemic heart disease requiring treatment, arrhythmia, cardiac infarction within 6 months before enrollment, hepatic failure, hemorrhagic peptic ulcer, poorly controlled diabetes) 9)History of Severe drug allergies. 10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 11) Physician concludes that the patient's participation in this trial is inappropriate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response Rate
- Secondary Outcome Measures
Name Time Method Overall Survival Progression-free Survival Disease Control Rate Incidence and Severity of Adverse Events