Assessment of Quality of Life and Outcomes in Patients Treated With Stereotactic Body Radiation Therapy (SBRT) for Primary Renal Cell Carcinoma (RCC) - AQuOS-RCC
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Patient Quality of Life
研究概览
简要总结
Stereotactic body radiotherapy (SBRT) is an emerging radiotherapy technique that precisely delivers high doses of radiation to tumours. It has been investigated as definitive treatment for an increasing variety of primary tumours including lung, liver, prostate, and now renal cell carcinoma (RCC). The principal aims of this study are to prospectively assess quality of life (QoL) and oncologic outcomes in non-surgical patients who receive SBRT for the treatment of RCC.
详细描述
There is an evolving body of literature that shows high rates of tumour control and minimal associated toxicities with SBRT to treat RCC. However, the majority of published evidence is retrospective in nature, and there is a scarcity of data on the impact on quality of life and cost-effectiveness of kidney SBRT.
The principal aims of this multicentre study are to prospectively assess QoL and oncologic outcomes in non-surgical patients who receive SBRT for the treatment of primary renal cell carcinoma.
The study population will include 30 consecutive patients treated with kidney SBRT on a conventional linear accelerator (35-40 Gy in 5 fractions) at the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto (OCC) and the Juravinski Cancer Center, Hamilton Health Sciences Centre, McMaster University (JCC).
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
- •Patients ≥18 years old
- •Medically inoperable or patient who refuses surgery
- •Histologic diagnosis of RCC where possible, or radiologic evidence of growth on surveillance
- •Lesion ≥2.5cm or recurrent lesion following local ablative therapy
- •Written informed consent
- •Participants must be able to understand the English-language or with the aid of a translator
排除标准
- •Prior abdominal radiation
结局指标
主要结局
Patient Quality of Life
时间窗: Up to 5 years after treatment
To evaluate quality of life scores
次要结局
- Treatment-Related Toxicity(Up to 5 years after completion of treatment)
- Cost-Effectiveness(Up to 5 years after completion of treatment)
- Oncologic Outcomes(Up to 5 years after completion of treatment)
研究者
William Chu, MD, MSc, FRCPC
Radiation Oncologist
Sunnybrook Health Sciences Centre