A phase I study of weekly nab-Paclitaxel/Carboplatin with concurrent thoracic radiotherapy in elderly patients with unresectable locally advanced non-small cell lung cancer
- Conditions
- on-small-cell lung cancer
- Registration Number
- JPRN-UMIN000014764
- Lead Sponsor
- Shizuoka cancer center
- Brief Summary
Brief summary: Weekly nab-paclitaxel plus carboplatin combined with concurrent thoracic radiotherapy is associated with a high treatment completion rate and exhibits promising safety and efficacy in elderly patients with locally advanced NSCLC. Based on these results, a randomized phase III study of chemoradiotherapy for elderly patients with locally advanced NSCLC comparing weekly nab-paclitaxel plus carboplatin with daily carboplatin (JCOG1914) is currently enrolling.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 19
Not provided
1)Active double cancer 2)History of severe infections or complications 3)HBs antigen positive 4)History of thoracic radiotherapy 5)Radiographically (chest CT image) confirmed interstitial pneumonitis or pulmonary fibrosis 6)Severe emphysema, chronic bronchitis, asthma 7)History of drug-induced pneumonia or severe drug allergies 8)Uncontrolled diabetes despite continuing treatment of insulin 9)Unstable angina, cardiac infarction within 6 months before enrollment 10)Obvious abnormality of the electrocardiogram 11)Grade 2 or higher peripheral neuropathy 12)A fever of over 38 degrees 13)Continuous systemic administration of steroid or immunosuppressant 14)Patients with severe mental illness 15)Unsuitable patients judged by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method