ACTRN12608000061336尚未招募2 期
A randomised phase II study comparing cisplatin and docetaxel with or without cetuximab given as neoadjuvant therapy in patients with stage II and IIIA resectable non-small cell lung cancer.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 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
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1) Histological diagnosis of NSCLC
- •2) Adequate baseline histological specimen available
- •3) Measurable primary tumour
- •4) Stage II or IIIA
- •5) Considered to be surgically resectable by thoracic surgeon
- •6) No prior therapy for NSCLC
- •7) Performance Status 0-1
- •8) Peripheral neuropathy no worse than grade I
- •9) Adequate organ function including lung, hepatic, renal and haematological function
- •10) Written informed consent
排除标准
- •1) No prior malignancy within 5 years
- •2) No other concurrent investigational drug
- •3) No active infection
- •4) No pregnancy or breast feeding
- •5) No serious concomitant medical or psychiatric disorders
- •6) No significant cardiovascular disease
- •7) No concurrent systemic corticosteroid (prednisolone >10 mg/day, or equivalent)
- •8) No history of severe hypersensitivity reactions to polysorbate 80 or any of the study medications.
研究者
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