A Feasibility Study of Re-irradiation Using Stereotactic Body Radiation Therapy (SBRT) and Cetuximab for Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30
研究概览
简要总结
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. 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. Giving stereotactic body radiation therapy together with cetuximab may kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects of radiation therapy given together with cetuximab and to see how well it works in treating patients with recurrent head and neck cancer.
详细描述
OBJECTIVES:
Primary
- To assess the toxicity of stereotactic body radiotherapy delivered concurrently with cetuximab in patients with recurrent squamous cell carcinoma of the head and neck.
Secondary
- To assess the feasibility of delivering this regimen in these patients.
- To assess the impact of this regimen on local control, distant control, and overall survival of these patients.
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 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 oral cavity, paranasal sinuses, nasopharynx, larynx, hypopharynx, or oropharynx
- •Medically or surgically inoperable disease or patient refuses surgery
- •Recurrent disease
- •Previously irradiated disease meeting the following criteria:
- •Prior radiotherapy completed > 6 months from re-irradiation
- •Prior radiotherapy in the region of the study cancer that would result in overlap of radiation therapy fields
- •Majority of the recurrent tumor volume (> 50%) received prior radiotherapy dose of 30-75 Gy
- •No distant metastatic disease
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 3 months
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 60 days after completion of study treatment
- •No prior allergic reaction to study drugs
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior surgical resection of the recurrent primary tumor and/or regional lymphatics
排除标准
- 未提供
研究组 & 干预措施
Cetuximab
Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5
干预措施: stereotactic body radiation therapy (Radiation)
Cetuximab
Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5
干预措施: cetuximab (Biological)
结局指标
主要结局
Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30
时间窗: Daily while on Treatment
次要结局
- Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients(2 years)
- Local and Distant Control(very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter.)
- Overall Survival(very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter)