Palliative Expeditiously Adaptive Quad Shot Radiation Therapy (PEAQ-RT): A Pilot Study of Consolidated Simulation and Target Identification of Quad Shot Radiation Therapy Using an Adaptive Radiotherapy Workflow With a Novel Ring Gantry Radiotherapy Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility as measured by the successful completion of Quad shot radiation using CBCT instead of routine CT simulation in 80% of attempted simulated patients
研究概览
简要总结
The investigators propose evaluating the feasibility of using the novel cone beam computed tomography (CBCT)-guided Ethos system to deliver expedited, adaptive Quad shot radiation for the purpose of palliative radiation of patients with advanced head and neck cancers or patients with a history of any malignancy experiencing current head and neck lesions. Quad shot radiation was selected as the palliative regimen of choice given its low toxicity profile, well published efficacy in palliation, frequent usage in the US for palliation of head and neck cancers, and safety in the setting of re-irradiation. The use of the Ethos platform to perform online adaptive radiation planning and delivery remains novel and untested. The Ethos system would be used to consolidate CT simulation, replanning, and treatment for Quad shot patients receiving treatment with the benefit of reduced patient travel and a reduction in the unwanted delay between Quad shot cycles. The goal of this pilot study will be to evaluate the feasibility of the Ethos system to eliminate the need for a CT simulation for cycles 2 and 3 of Quad shot radiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •History of a head and neck malignancy or history of any malignancy experiencing current head and neck lesions suitable for radiation. Past history of radiotherapy is allowed for inclusion and brain metastases are allowed for inclusion.
- •Deemed medically fit for Quad shot radiation by treating physician
- •At least 18 years of age.
- •Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
排除标准
- •Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by treating physician or protocol PI, documentation of this exception is sufficient in lieu of pregnancy test.
结局指标
主要结局
Feasibility as measured by the successful completion of Quad shot radiation using CBCT instead of routine CT simulation in 80% of attempted simulated patients
时间窗: Completion of treatment by all patients enrolled (estimated to be 3 years and 12 weeks)
次要结局
- Average time (days) required from initial consult to completion of radiation therapy for patient travel and visits to the department(Approximately 12 weeks)
- Percentage of patients from whom repeat CT simulation was eliminated(Completion of treatment by all patients enrolled (estimated to be 3 years and 12 weeks))