NCT00916097已完成2 期
A Multicenter Phase II Trial of Docetaxel Combined With Cisplatin (CDDP) as a Neo-Adjuvant Chemotherapy in Patients With Loco Regionally Advanced Undifferentiated Carcinoma of Nasopharyngeal Type (UCNT)
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
- Sanofi
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Evaluation of tumor response in patients with measurable disease according to RECIST criteria
研究概览
简要总结
Primary Objective:
To estimate the overall response rate after neo-adjuvant chemotherapy of Docetaxel 75 mg/m2 in combination with Cisplatin 75 mg/m2 given for 3 cycles, and followed by conventional radiotherapy in UCNT.
Secondary Objectives:
To evaluate:
- The radiological response after chemotherapy and radiotherapy
- The pathological response after chemotherapy by cavum biopsy
To estimate:
- The duration of overall response
- The time to progression (T.T.P)
To analyze:
- The overall survival
- The safety profile
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
docetaxel 75mg/m2 in combination with cisplatin 75mg/m2 given every 3 weeks for 3 cycles
干预措施: DOCETAXEL(XRP6976) (Drug)
结局指标
主要结局
Evaluation of tumor response in patients with measurable disease according to RECIST criteria
时间窗: on day 21 of each treatment cycle for neoadjuvant chemotherapy, on day 64 and day 71 (3 to 4 weeks after the third chemotherapy)
次要结局
- Overall response duration(from baseline to the end of the study)
- Estimation of the time to progression(from baseline to the end of the study)
- Overall survival(from baseline to the end of the study)
- Evaluation of the radiological response after chemotherapy and radiotherapy(from baseline to the end of the study)
- Evaluation of the pathological response after chemotherapy(between day 64 and day 71 of the treatment)
研究者
研究点 (1)
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