A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy in the Definitive Treatment of Head-and-Neck Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Feasibility of adaptive radiation therapy in the definitive treatment (MLC-based IMRT or helical tomotherapy)
研究概览
简要总结
Patients with head and neck cancer and are schedule to receive standard radiation therapy known as IMRT to treat cancer
详细描述
In this study, we will plan additional measurements of the position of the patient's organs weekly during radiation treatment. We will analyze these measurements in order to evaluate whether we need to adjust our treatment procedures for the remainder of the treatments. We might adjust the dose of radiation received to specific organs in order to try to minimize the amount of radiation the healthy tissue receives.
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
- •Age >= 18
- •Karnofsky Performance Status of >= 60
- •New diagnosis of head-and-neck cancer, all subsites included (i.e. nasopharynx, oropharynx, oral cavity, hypopharynx, larynx.)
- •All stages with measurable gross disease (>= 1.0 cm) by CT imaging
- •Pathologic confirmation of squamous cell carcinoma by biopsy or cytology
- •Signed study-specific consent form
- •Sequential or concurrent chemotherapy is allowed but not mandated. (no chemotherapy is allowed if patient is judged not to be a candidate for chemotherapy by the medical oncologist)
- •Exclusion Criteria
- •Age < 18
- •Karnofsky Performance Status < 60
- •Radiographic or pathologic evidence of distant metastatic disease (i.e. other than cervical lymph nodes)
- •Prior radiation therapy to the head-and-neck region
排除标准
- 未提供
结局指标
主要结局
Feasibility of adaptive radiation therapy in the definitive treatment (MLC-based IMRT or helical tomotherapy)
时间窗: 7 weeks
Feasibility is determined by employing weekly 3D onboard imaging for plan re-evaluation and initiation of an adaptive process if the original PTV and/or normal structure goals are compromised.
次要结局
- Measure additional time required by physician and ancillary staff for the process of adaptive IMRT(7 weeks)
- Identify a subset of patients in whom adaptive IMRT would be recommended(7 weeks)
- Measure acute and late toxicity(Until patient death)
- Local, regional, and distant recurrence(Until recurrence)