Docetaxel and Cisplatin Chemotherapy Followed by Radiochemotherapy in Patients With Inoperable, Locally Advanced Esophageal Cancer, A Multicenter Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 10
- 主要终点
- Proportion of patients without local failure measured 6 months after completion of study treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel and cisplatin may also make tumor cells more sensitive to radiation therapy. Giving docetaxel and cisplatin together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together with radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the local tumor-control rate in patients with locally advanced, unresectable esophageal cancer treated with docetaxel, cisplatin, and radiotherapy.
Secondary
- Determine the feasibility of this regimen in these patients.
- Determine the adverse reactions of this regimen in these patients.
- Determine local- and distant-failure and time to local- and distant-failure in patients treated with this regimen.
- Determine overall survival of patients treated with this regimen.
- Determine the long-term survival rate in patients treated with this regimen.
- Determine whether early improvement of dysphagia is a predictive marker in patients treated with this regimen.
- Determine quality of life and clinical benefit in patients treated with this regimen.
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 70 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
Arm I
Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71. Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
干预措施: Docetaxel and Cisplatin (Drug)
Arm I
Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71. Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Proportion of patients without local failure measured 6 months after completion of study treatment
时间窗: 6 months
次要结局
- Adverse reactions measured after completion of study treatment(6 months)
- Successful completion of therapy measured after completion of study treatment(6 months)
- Dysphagia as measured 6 months after completion of study treatment(6 months)