A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 125
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin and paclitaxel may make tumor cells more sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) and giving them with radiation therapy may kill more tumor cells. It is not yet known whether giving radiation therapy together with combination chemotherapy is more effective than giving combination chemotherapy alone in treating head and neck cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating patients with recurrent head and neck cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare overall survival of patients with previously irradiated unresectable locally recurrent squamous cell carcinoma of the head and neck treated with radiotherapy, cisplatin, and paclitaxel vs cisplatin-based chemotherapy alone.
Secondary
- Compare progression-free survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare quality of life, functional/performance status, and quality-adjusted survival of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（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
Radiotherapy and chemotherapy
Radiotherapy/paclitaxel/cisplatin/filgrastim
干预措施: filgrastim (Biological)
Radiotherapy and chemotherapy
Radiotherapy/paclitaxel/cisplatin/filgrastim
干预措施: cisplatin (Drug)
Radiotherapy and chemotherapy
Radiotherapy/paclitaxel/cisplatin/filgrastim
干预措施: paclitaxel (Drug)
Radiotherapy and chemotherapy
Radiotherapy/paclitaxel/cisplatin/filgrastim
干预措施: radiation therapy (Radiation)
Chemotherapy
Cisplatin/fluorouracil/paclitaxel/docetaxel
干预措施: cisplatin (Drug)
Chemotherapy
Cisplatin/fluorouracil/paclitaxel/docetaxel
干预措施: docetaxel (Drug)
Chemotherapy
Cisplatin/fluorouracil/paclitaxel/docetaxel
干预措施: fluorouracil (Drug)
Chemotherapy
Cisplatin/fluorouracil/paclitaxel/docetaxel
干预措施: paclitaxel (Drug)
结局指标
主要结局
Overall Survival
时间窗: Date of death or last follow-up
次要结局
未报告次要终点