A Phase II Trial of Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Primary Renal Cancer (RCC)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Eliminate its growth and tumor viability.
研究概览
简要总结
The goal of this phase II clinical trial is to evaluate the efficacy of the completely non-invasive treatment option of stereotactic radiation therapy for the treatment of biopsy proven and growing small renal tumors.
详细描述
Current treatment options for primary renal cancer include surgery or ablative techniques-all are invasive or minimally invasive options. The completely noninvasive treatment option of stereotactic radiation therapy (SABR), which has become standard of care in many cancer sites, has not been explored for primary renal cancer. With multiple technological advances, it is now feasible to safely treat a moving intra-abdominal tumor such as that in a kidney. This proposed clinical trial evaluates the efficacy of SABR in treating patients with early renal cancers. Growing renal masses will first be biopsied to confirm the diagnosis of renal cancer. Patients will then undergo treatment with SABR of 3-5 fractions completing within three weeks. Treatment response will be evaluated using sequential MRI scans and a second tumor biopsy one year after treatment. Monitoring of treatment toxicity and kidney function will also be performed.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subject has received any treatment for the treating renal mass; such as RFA or cyroablation.
- •If other renal masses received RFA or cryoablation or surgery, then these patients are eligible.
- •Subjects received previous abdominal radiation
- •Evidence of Metastatic Disease, unless disease-free for ≥ 3 years prior to registration, (non-melanomatous skin cancer and in-situ cancers are okay).
- •Female subjects who are pregnant or planning to become pregnant during the course of SABR.
结局指标
主要结局
Eliminate its growth and tumor viability.
时间窗: 2 years
To evaluate if SABR to small renal tumors is able to eliminate its growth and viable tumor.
次要结局
- growth rate of renal tumors(2 years)
- progression of disease(2 years)
- Adverse events(2 years)
- Tumor Viability(one year)
- Renal function(2 years)
研究者
Raquibul Hannan
Associate Professor of Medicine
University of Texas Southwestern Medical Center