Kilovoltage Conebeam Imaging Based Adaptive Radiation Therapy for Head & Neck Patients Treated With Intensity Modulated Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Clinical patient response
研究概览
简要总结
The purpose of this study is to determine the utility of kilovoltage (kV) cone beam CT imaging to track the dose delivered in head and neck cancer patients, to assess the benefit of cone beam CT to patients set-up for radiation treatment, to determine how shifts based on kV cone beam CT compare to the standard approach (orthogonal pair), and to develop remote access tools (preferably internet-based) so that the MD can approve these plans in real time.
详细描述
The investigators' secondary objectives for this study are to assess the possibility of using kV cone beam for treatment replanning as compared to standard the treatment planning, to determine the need and feasibility of adaptive radiation therapy, to develop concept of establishing cumulative DVH (C-DVH) with daily updates and compare it to planned DVH (P-DVH), to identify tolerance margins, to evaluate local control, locoregional control, distant metastasis, and overall survival, to assess patient quality of life,and to develop predictors of patients which may benefit from ART.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients should have an ECOG (Eastern Clinical Oncology Group) performance status of 0-2
- •Patients should meet at least one of the following criteria:
- •Locally advanced cancer (T3-T4 and/or N2-N3)
- •Tumors wrapping around critical structures such as the optic nerves, optic chiasm, or brainstem
- •Significant expected weight loss.
排除标准
- •Previous surgical procedure more significant than a biopsy to the primary tumor or regional lymph nodes.
- •Poor renal function (inability to undergo a CT with IV contrast)
- •Previous radiation therapy to the head and neck.
- •Inability to tolerate prolonged immobilization.
- •Children and women who are pregnant or decline to use contraception.
结局指标
主要结局
Clinical patient response
时间窗: From the date of initiation of radiation therapy, until date of first progression or until date of death (approximately 5 years).
This will assessed by CT scan or MRI 4-5 weeks post concurrent chemo.
次要结局
- Patient quality of life(During radiation therapy (7-9 weeks))