A phase I/II study of carboplatin in combination with nab-paclitaxel and thoracic radiation in elderly patients with previously untreated non-small cell lung cancer
- Conditions
- ocally Advanced Non-Small Cell Lung Cancer
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 43
Not provided
1)Radiographically (chest CT image) confirmed interstitial pneumonitis or pulmonary fibrosis 2)V20 exceed 35% 3)Patients with opposite hilar lymph nodes metastases, or massive pleural or pericardial effusion 4)Patients with active double cancer 5)Patients with serious disease condition (severe infections,diarrhea,ileus,poorly controlled diabetes, unstable angina,cardiac infarction within 6 months before enrollment,severe heart failure, etc.) 6)Severe emphysema, chronic bronchitis, asthma 7)Postoperative relapse 8)History of drug-induced pneumonia or severe drug allergies 9)History of hypersensitivity to albumin preparations 10)Grade 2 or higher peripheral neuropathy 11)Patients with severe mental illness 12)HBs antigen positive, or HBV-DNA positive ( HBs antigen negative but HBs antibody or HBc antibody positive) 13)Unsuitable patients judged by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method phase I:determine the recommended dose phase II:response rate
- Secondary Outcome Measures
Name Time Method phase I:safety, response rate, progression free survival,overall survival, completion rate of chemoradiotherapy,2year survival rate phase II:safety, progression free survival, overall survival, completion rate of chemoradiotherapy,2year survival rate