A Prospective Randomized Pilot Trial of Stereotactive Body Radiation Therapy Versus Radiofrequency Ablation for the Management of Small Renal Masses.
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Treatment failure
研究概览
简要总结
The execution of this study is pertinent to evaluating SBRT's short- and long-term efficacy and safety in the treatment of SRMs. This study will be the first to compare RFA and SBRT in the treatment of SRMs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Patients ≥18 years of age and capable of providing informed consent
- •Patients scheduled for treatment of their SRM using SBRT or RFA
- •Patients who received a biopsy of their SRM prior to their scheduled SBRT or RFA treatment
- •Patients who are willing to have a biopsy 12 months post-procedure
- •Patients with renal tumor(s) ≤ 4.0 cm
排除标准
- •Patients with large renal tumor(s)>4.0 cm
- •Patients who are unable to have a general anesthetic
- •Patients who did not receive a biopsy of their SRM prior to their scheduled SBRT or RFA treatment
- •Patients who are unable to comply with post-operative and/or follow-up protocol/phase of study
- •Evidence of metastatic disease
- •Uncorrectable bleeding diathesis
研究组 & 干预措施
Stereotactic body radiation therapy (SBRT)
干预措施: Stereotactive body radiation therapy (Radiation)
Radiofrequency Ablation (RFA)
干预措施: Radiofrequency Ablation (Procedure)
结局指标
主要结局
Treatment failure
时间窗: 12 Months
Failure will be defined as enhancement of ablated tissue greater than 10 Hounsfield units by CT contrast.
Overall Survival
时间窗: 12 Months
Defined as post-procedural survival.
Disease recurrence
时间窗: 12 Months
Defined as disease recurrence rate after a single procedure, including positive biopsy result.
Disease free survival
时间窗: 12 Months
Defined as disease-free survival rate after a single procedure
次要结局
- Number of patients that experienced an adverse event.(12 Months)
- Tumour Size(12 Months)
- Renal Function -eGFR(12 Months)
- Renal Function - Creatinine Clearance(12 Months)
- Renal Function - Serum Creatinine(12 Months)
- Complication Rate(12 Months)
- Change in score for quality of life(12 Months)
- Duration of hospital stay(Days)
- Cost analysis(12 Months)
研究者
Anil Kapoor
Principal Investigator
St. Joseph's Healthcare Hamilton