Prospective Phase II Study of Stereotactic Body Proton Therapy for Treatment of PrimAry Renal Cell Carcinoma (SPARE)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in kidney function after PROTON-BASED SBRT treatment as assessed by serum creatine levels
研究概览
简要总结
This study examines the impact of proton based stereotactic radiation therapy (SBRT) on kidney function as well as other oncologic outcomes including local control, locoregional and systemic failure, progression free and overall survival.
详细描述
The incidence of kidney cancer diagnosis has been increasing over the last years. Surgical resection represents the mainstay treatment. However, many patients are deemed unfit for surgery due to medical comorbidities or technical limitations. There are non-surgical options including active surveillance, cryotherapy, microwave ablation, radiofrequency and stereotactic radiation therapy (SBRT). SBRT using conventional x-rays has recently been shown to improve outcomes for patients with primary renal cell carcinoma (RCC) in terms of local control and toxicity. However, this treatment was associated with a significant decline in kidney function that necessitates additional intervention including dialysis in some patients. Proton therapy represents an emerging technique with unique properties that allow the bulk of the proton cancer fighting energy to be released at the tumor (Bragg peak) while sparing nearby healthy tissues and organs, particularly the remaining healthy kidney, ipsilateral kidney, bowels, spine and liver. With this technology, both kidneys, the remaining ipsilateral and contralateral, could be spared and thus less damage is expected. This study aims to study the impact of proton based SBRT on the kidney function.
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
- •Biopsy proven renal cell carcinoma.
- •No clinical or radiographic evidence of metastatic disease.
- •Not a candidate for surgical treatment or local ablative procedures.
- •Subjects are able to undergo either an MRI or administration of contrast agent for CT.
排除标准
- •Prior history of radiation treatment with overlapping fields.
- •Patients with proven metastatic disease.
- •Female subjects who are pregnant or planning to become pregnant during the treatment.
研究组 & 干预措施
Proton Stereotactic Body Radiation Therapy (SBRT)
The SBRT group is the single arm of this study.
干预措施: Proton Stereotactic Body Radiation therapy (SBRT) (Radiation)
结局指标
主要结局
Change in kidney function after PROTON-BASED SBRT treatment as assessed by serum creatine levels
时间窗: Baseline and every 3-6 months up to 2 years post treatment
Change in serum creatine levels from Baseline visit.
Change in kidney function after PROTON-BASED SBRT treatment as assessed by estimated glomerular rate (eGFR) values
时间窗: Baseline and every 3-6 months up to 2 years post treatment
Change in eGFR values from Baseline visit.
次要结局
- Systemic progression of disease after PROTON-BASED SBRT treatment as assessed by appearance of lesions(Baseline and every 3-6 months up to 2 years post treatment)
- Time to locoregional progression(Baseline and every 3-6 months up to 2 years post treatment)
- Local progression of disease after PROTON-BASED SBRT treatment as assessed by size or appearance of lesions(Baseline and every 3-6 months up to 2 years post treatment)
- Number of PROTON-BASED SBRT treatment Adverse Events(24 months post treatment)
- Overall survival(24 months post treatment)