A Phase III Trial of Standard Fractionation Radiation and Concurrent Single Agent Cisplatin, With and Without Docetaxel, Cisplatin, and 5-Fluorouracil Induction Chemotherapy, in Patients With Advanced Oropharyngeal Squamous Cell Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 72
- 主要终点
- Survival at 2 years
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, 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. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known whether giving combination chemotherapy together with radiation therapy is more effective than giving cisplatin together with radiation therapy in treating cancer of the oropharynx.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and radiation therapy to see how well they work compared to cisplatin and radiation therapy in treating patients with stage III or stage IV cancer of the oropharynx.
详细描述
OBJECTIVES:
Primary
- Compare the overall survival of patients with previously untreated stage III or IV squamous cell carcinoma of the oropharynx treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by radiotherapy and cisplatin versus radiotherapy and cisplatin only.
- Compare the progression-free survival in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life and functional status of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to primary cancer site (base of tongue vs other), nodal extent (N0-1 vs N2-3), radiotherapy plan (conventional [2-D or 3-D conformal radiotherapy] vs intensity modulated radiotherapy). Patients are randomized to 1 of 2 treatment arms.
- Arm I (induction chemotherapy with or without salvage surgery followed by chemoradiotherapy)
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
cisplatin/RT alone
cisplatin and radiation therapy
干预措施: radiation therapy (Radiation)
cisplatin/RT alone
cisplatin and radiation therapy
干预措施: cisplatin (Drug)
induction chemo followed by cisplatin/RT
docetaxel, cisplatin and 5-fluorouracil induction chemotherapy followed by surgery and/or cisplatin and radiation therapy
干预措施: cisplatin (Drug)
induction chemo followed by cisplatin/RT
docetaxel, cisplatin and 5-fluorouracil induction chemotherapy followed by surgery and/or cisplatin and radiation therapy
干预措施: docetaxel (Drug)
induction chemo followed by cisplatin/RT
docetaxel, cisplatin and 5-fluorouracil induction chemotherapy followed by surgery and/or cisplatin and radiation therapy
干预措施: 5-fluorouracil (Drug)
induction chemo followed by cisplatin/RT
docetaxel, cisplatin and 5-fluorouracil induction chemotherapy followed by surgery and/or cisplatin and radiation therapy
干预措施: surgery (Procedure)
结局指标
主要结局
Survival at 2 years
时间窗: 2 years
次要结局
- Progression-free survival by FACT-HN CTCAE v 3.0 at 2 years(2 years)
- Toxicity by CTCAE v 3.0 after induction chemotherapy or after chemotherapy and radiotherapy(after chemotherapy)
- Incidence of surgical resection(after treatment)
- Site of relapse(at relapse)
- Quality of life by FACT-HN week 19 after first and second registration date (arm 1)(after first and second registrations)