Phase II Study: Stereotactic Ablative Radiotherapy for Renal Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- To evaluate the radiation induced renal impairments in patients receiving SABR.
研究概览
简要总结
Renal Cell Carcinoma (RCC) is the most common type of kidney cancer. The usual treatment for this type of cancer is surgery. Considering the most common patients are an average age of 65 and some are not suitable candiates for surgery, there is great interest in non-surgical alternatives for kidney cancer treatments. This study will investigate the use of Stereotactic Ablative Radiosurgery (SABR) for renal tumors. SABR is a non-invasive alternative, which involves delivery of high doses of radiation to the target, while minimizing the risk of injury to the surrounding organs. Patients will be seen before and end of treatmetn and will be followed at 4 month intervals for up to 2 years. During the follow ups, patients will be asked to complete a quality of life questionnaire and will have standard of care imaging.
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
- •Solid Kidney Mass (primary RCC or metastasis) amenable to SABR ≤6cm
- •Histological or radiological diagnosis of renal tumor
- •Inoperable: High risk for surgery or declined surgery
- •ECOG performance status of 0-3
排除标准
- •≥5 active metastases
- •Systemic therapy (except endocrine therapy) within 60 days prior to SABR
- •Prior abdominal radiotherapy with fields overlap resulting in excessive doses to the involved kidney
- •Patients with end stage renal failure > 4(KDOQI guidelines)
- •Familial Syndrome: Von Hippel-Lindau disease, Polycystic Kidney Disease, Hereditary Papillary RCC or Tuber Sclerosis
研究组 & 干预措施
Stereotactic Ablative Radiotherapy
Adult patients with Kidney mass (either primary or metastasis) amenable to SABR
干预措施: Stereotactic Ablative Radiotherapy (Radiation)
结局指标
主要结局
To evaluate the radiation induced renal impairments in patients receiving SABR.
时间窗: 2 years
The prevalence of nephron toxicity in patients treated with SABR, measured by the change in Glomerular Filtration Rate (GFR) every 4 months over 2 years.
次要结局
- Chronic Kidney Disease Stage Progression(2 years)
- Patient Reported Outcomes(2 years)
- Incidence of acute and late toxicities(2 years)
- 2-year Local recurrence rate(2 years)