Re-irradiation and Stereotactic Cetuximab in Patients With Recurrent Carcinoma of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Percentage of patients with nonprogressive disease at 12 months according to RECIST criteria
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving cetuximab together with stereotactic radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how giving cetuximab together with stereotactic radiation therapy works in treating patients with recurrent squamous cell carcinoma of the head and neck cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Evaluate local control at 12 months in patients with recurrent squamous cell carcinoma of the head and neck treated with cetuximab and stereotactic radiotherapy.
Secondary
- Determine the incidence of cutaneous toxicity.
- Assess the care and development of skin reactions.
- Determine the quality of life of patients treated with this drug.
- Determine tumor response at 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed squamous cell carcinoma of the head and neck
- •Unresectable disease
- •Recurrent disease
- •No metastatic disease
- •Disease in previously irradiated area must be proven by biopsy or imaging
- •At least 3 months between prior radiotherapy and diagnosis of recurrent disease
- •Surgery or brachytherapy must be possible
- •Measurable or evaluable disease by RECIST criteria
- •No available curative therapy
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 60-100%
- •Not pregnant or nursing
- •No psychological, familial, social, or geographical reasons that would make monitoring the patient impossible
- •No other malignant disease
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No concurrent participation in another clinical study of an experimental drug
排除标准
- 未提供
结局指标
主要结局
Percentage of patients with nonprogressive disease at 12 months according to RECIST criteria
次要结局
未报告次要终点