Prospective Observational Trial of Image-guided Ablative STereotactic bOdy Radiation Therapy for Primary kidNey Cancer: the STONE Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- evaluate LC of treated lesions at 1 year
研究概览
简要总结
The study objective is to evaluate the use of Stereotactic Body Radiotherapy (high dose of radiation in a few fractions) to cure primary renal cancer in those patients that are not indicated to surgery (high risk of complications, refusal of the patient). This therapy is already used in clinical setting for many tumors with good tolerance as it is not invasive, does not require anesthesia and hospitalization making it suitable for elderly people and frail patients. However there are not enough information regarding the use of ablative doses for the cure of renal cancer and for this reason this study aims to support the use of Stereotactic Body Radiotherapy as a standard of care for inoperable primary renal tumor. This is an observational study, so it collects data from clinical pratice only and does not request study specific procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •ECOG performance status 0 - 2
- •Histologically confirmed diagnosis of primary RCC
- •cT1 stage tumor with single lesion with maximum diameter of 7 cm
- •Medically inoperable or at high risk of complication from surgery, or declined surgery
- •Absence of metastatic disease
- •Written informed consent
排除标准
- •Estimated glomerular filtration rate (eGFR) < 30 mls/min
- •Previous radiotherapy on the same site
- •Previous systemic therapy for RCC
- •Tumor diameter larger than 7 cm
- •Presence of metastatic disease
- •Life expectancy < 3 months
结局指标
主要结局
evaluate LC of treated lesions at 1 year
时间窗: from end of treatment to 1 year
local progression is defined as an enlargement of at least 20% relative and 5 mm absolute increase of sum of diameters of target lesions compared to baseline at least after 6 months from treatment end
次要结局
- To assess kidney function with serum creatinine and estimated glomerular filtration rate(from start of treatment to 3 years)
- to assess acute and late toxicity(from start of treatment to 3 years)
- Progression Free Survival (PFS)(from end of treatment to 1 year)
- metastasis free survival(from end of treatment to 3 years)
- Overall Survival(from end of treatment to 3 years)
- To asses Quality of Life(from start of treatment to 3 years)