A Prospective Non-Inferiority Trial of the Use of Adaptive Radiotherapy for Head and Neck Cancer Undergoing Radiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 15
- 主要终点
- Number of patients with locoregional recurrence-free interval
研究概览
简要总结
The purpose of this study is to demonstrate that adaptive radiotherapy (ART) in head and neck cancer patients are comparable to historical controls in head and neck patients undergoing standard intensity-modulated radiation therapy (IMRT) without ART.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with pathologically confirmed cancers of paranasal sinuses, oropharynx, oral cavity, nasopharynx, larynx, hypopharynx, and unknown primary and will receive definitive radiation therapy with or without chemotherapy.
- •Karnofsky performance status >= 70%
- •Women of childbearing potential need to have a negative serum pregnancy test at the time of therapy
- •Participants must have the ability to understand and the willingness to sign a written consent form
排除标准
- •Female participants who are pregnant or breast feeding
- •Participants who are not able to comply with study and/or follow up procedures
- •Participants who have received induction chemotherapy before radiation treatment
- •Participants who had prior head and neck radiation therapy
- •Participants who are enrolled in a national/international cooperative group trials
- •Patients with metastatic disease
结局指标
主要结局
Number of patients with locoregional recurrence-free interval
时间窗: 2 years
This is assessed by imaging studies and/or physical exams at follow- up visits. This will include a diagnostic FDG PET/CT scan. CT and/or MRI of the primary site and neck will also be recommended. Patients will be classified as locoregional recurrence-free as long as there is no evidence of locoregional recurrence of disease by clinical evaluation, CT, MRI, and/or PET-CT according to the standard of care. For patients achieving complete response of disease, no further imaging study is necessary.
次要结局
未报告次要终点