JPRN-jRCTs042180077已完成1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 75age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Non-small cell lung cancer (NSCLC) diagnosed by cytological or histological examination
- •2) Unresectable locally advanced NSCLC (stage III)
- •3) Possible for definitive radiotherapy
- •4) No previous chemotherapy and thoracic radiotherapy
- •5) At least one measurable lesion
- •6) Age75 years or more
- •7) ECOG performance status 0-1
- •8) Sufficient major organ function
- •9) Life expectancy; at least 90 days
- •10) Written informed consent
排除标准
- •1) Active double cancer
- •2) Severe infections or complications
- •3) HBs antigen positive
- •4) Previous thoracic radiotherapy
- •5) Interstitial pneumonia or fibrosis on CT
- •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 or myocardial infarction within 6 months
- •10) Obvious abnormality of the electrocardiogram
- •11) Grade 2 or higher peripheral neuropathy
- •12) Febrile more than or equal to 38 degrees
- •13) Systemic use of corticosteroid or immunosuppressive drug
- •14) Severe mental illness
- •15) Unsuitable for enrollment judged by attending physician
研究者
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