UPRIGHT-PRO: Prospective Development Study of Upright Proton Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Feasibility of upright proton therapy
研究概览
简要总结
This study is being done to evaluate whether cancer patients can safely and reliably receive proton radiation therapy while positioned upright. Proton therapy is an established form of radiation treatment, and the upright treatment system used in this study has been cleared by the U.S. Food and Drug Administration. The intent of this protocol is to observe the treatment methods, doses, and outcomes for the initial cohorts of patients treated with this upright device. This study will support research activities and evaluate feasibility as needed. Results of this study will be reported in the scientific literature but the investigators do not intend to report to the FDA for a new use or indication or change to the labeling; nor are the investigators required to do so.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any cancer patient (children and adults) recommended for proton therapy.
- •Participation in other clinical trials is allowed (including randomized trials of protons versus other treatments)
排除标准
- •Any patient that doesn't meet the inclusion criteria
结局指标
主要结局
Feasibility of upright proton therapy
时间窗: End of proton therapy (3 months)
Feasibility is defined by the proportion of evaluable patients who complete a technically successful course of upright proton therapy. Technically successful course of upright proton therapy is defined as ≥80% of prescribed proton fractions delivered with upright proton therapy. Feasible if ≥70% of evaluable cases meet technically successful criterion.
次要结局
- Quality of Life (FACT-G)(Baseline and end of proton therapy (3 months))
- Treatment Satisfaction (FACIT-TS-G)(End of proton therapy (3 months))
- Comfort/Stability Survey at Simulation(Baseline)