NCT00337532已完成2 期
A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2005年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Tumor response rate of locally advanced head and neck cancer to a paclitaxel-cisplatin combination regimen in a neoadjuvant setting and administered during maximum 3 cycles.
研究概览
简要总结
The purpose of this clinical research study is to learn if a paclitaxel-cisplatin combination regimen given in the neoadjuvant setting is active in locally advanced head and neck cancer. the safety of this treatment will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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, Stage II-IV (except M1), hand and neck cancer
- •> = 1 measurable lesion
- •not been previously treated for head and neck cancer
排除标准
- •history of another malignancy
- •organ allografts
- •pre-exiting neuropathy > = CTC grade 2
研究组 & 干预措施
paclitaxel-cisplatin combination regimen
Active Comparator
干预措施: Paclitaxel (Drug)
paclitaxel-cisplatin combination regimen
Active Comparator
干预措施: cisplatin (Drug)
结局指标
主要结局
Tumor response rate of locally advanced head and neck cancer to a paclitaxel-cisplatin combination regimen in a neoadjuvant setting and administered during maximum 3 cycles.
次要结局
- Toxicity for maximum 3 cycles
研究者
研究点 (2)
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