NCT01689194已完成2 期
A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy using Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators try to evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •locally advanced head and neck squamous cell carcinoma
- •oral cavity, oropharynx, hypopharynx, larynx
- •measurable lesion
- •unresectable
- •age 18 or more
- •ECOG 0 or 1
排除标准
- •distant metastasis
- •pregnancy
- •prior chemotherapy or radiation therapy
- •2ndary malignancy
- •other unfit medical condition
研究组 & 干预措施
genexolPM + cisplatin
Experimental
干预措施: genexolPM + cisplatin (Drug)
结局指标
主要结局
response rate
时间窗: every 2 cycles, 6wk later after chemotherapy
RECIST
次要结局
- Quality of life(every 3wk (every cycle))
- Locoregional control rate(every 3wk (every cycle))
- safety(every 3wk (every cycle))
研究者
Se-Hoon Lee
professor
Seoul National University Hospital
研究点 (1)
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