ACTRN12612000473864尚未招募2 期
A randomized phase 2 study to evaluate the effect of carboplatin with oral vinorelbine (navelbine [Registered Trademark]) followed by maintenance therapy with oral vinorelbine (navelbine [Registered Trademark]) or erlotinib (Tarceva [Registered Trademark]) on quality of life and progression free survival in metastatic non-small cell lung cancer in elderly patients.
Southern Health0 个研究点目标入组 100 人开始时间: 2012年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 70 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Patients > 70 years old,
- •2. Histologically or cytologically proven non-small cell lung cancer,
- •3. Stage 3B (not suitable for radical radiotherapy) or stage 4(7th IALC staging edition),
- •4. PS 0-1
- •5. Life expectancy > 12 weeks
- •6. Adequate bone marrow, hepatic and renal function
排除标准
- •1. Known hypersensitivity to drugs with similar chemical structures to study medication,
- •2. Active CNS disorder, symptomatic brain or leptomeningeal metastasis or CNS disease requiring steroid therapy,
- •3. Symptomatic neuropathy (sensory) > grade 1 according to the NCI Common Toxicity Criteria,
- •4. Cardiovascular disease (uncontrolled cardiac failure, or myocardial infraction within the previous 3 months, uncontrolled hypertension or arrhythmia),
- •5. Active infection requiring i.v. antibiotics within 2 weeks before the beginning of treatment,
- •6. Superior vena cava syndrome,
- •7. Long term oxygen therapy,
- •8. Unstable pleural effusion,
- •9. Unstable ascites or pericardial effusion,
- •10. History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix,
- •11. Radiotherapy within the previous 2 weeks,
- •12. Concomitant treatment with any other anticancer agent,
- •13. Uncontrolled hypercalcaemia,
- •14. Unstable concomitant disease,
- •15. Concomitant treatment with corticosteroids except chronic treatment ( > 1 month) at low dosing ( < 20 mg/ day of methylprednisolone or equivalent),
- •16. Significant malabsorption syndrome or disease affecting the gastro-intestinal tract function,
- •17. Participation to another clinical trial with any investigational drug study (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to study screening.
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