Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney, a Phase II Clinical Trial (FASTRACK II)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Activity and efficacy of SABR measured by Freedom from local progression assessed by RECIST Criteria
研究概览
简要总结
This study is evaluating the activity and efficacy of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of kidney cancers.
详细描述
Who is it for?
- Age > 18 years old
- All patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney
- ECOGperformance of 0-2 inclusive.
- Life expectancy > 9 months
- Either medically inoperable, technically high risk for surgery or decline surgery.
- Multidisciplinary decision for active treatment
Study Details:
Definitive external beam radiotherapy (EBRT) is often used to treat medically inoperable patients with cancers in many different organs, including the kidneys. However, renal cell carcinoma (RCC) is conventionally considered "radioresistant" to fully fractionated EBRT. In an effort to overcome the perceived "radioresistance" of RCC, severely hypofractionated EBRT in the form of stereotactic radiotherapy has renewed interest in the management of renal cell carcinoma with radiotherapy. This study will be evaluating the safety and effectiveness of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of cancers of the kidney.
Participants in this study will be allocated to receive either multi-fraction SABR (3 fractions over 2 weeks) or single fraction SABR (1 fraction only).
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
- •Age > 18 years old
- •All patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney
- •Eastern Cooperative Oncology Group (ECOG) performance of 0-2 inclusive.
- •Life expectancy > 9 months
- •Either medically inoperable, technically high risk for surgery or decline surgery.
- •Multidisciplinary decision for active treatment
排除标准
- •Pre-treatment estimated glomerular filtration rate < 30 mls/min
- •Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Delivery of targeted agents (such as sunitinib) are allowable only when at least 7 days separate the delivery of the proposed agent and the delivery of the stereotactic radiotherapy.
- •Previous high-dose radiotherapy to an overlapping region
- •Tumours of larger than 8cm is size
结局指标
主要结局
Activity and efficacy of SABR measured by Freedom from local progression assessed by RECIST Criteria
时间窗: 12mths post treatment
Responsive Evaluation Criteria in Solid Tumors (RECIST)
次要结局
- Tolerability of SABR Assessed as cummulative incedents of severe toxicity by CTCAE v4(From date of treatment commencement until first documented progression or date of death from any cause, whichever came first, assessed from 4wks, 3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mth post treatment)
- Estimated Survival after SABR assessed by clinincal assessment(assessed up to 60 months)
- Estimated Distant Failure Rate after SABR assessed by CT scan and clinical assessment(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed from 6 mths, 9 mths, 12 mths, 18mths, 33 mths, 42 mths, 51 mths, and 60 mths post treatment)
- Renal Function Change after SABR assessed by split renal function and GFR(Baseline, 12mths post treatment, and 24 mths post treatment)
- Renal Function Change after SABR assessed by using eGFR(Baseline,3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mths)