CyberKnife Stereotactic Radiation for Unresectable Renal Tumors/PhaseI Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- To determine the maximum tolerated dose of CyberKnife radiation
研究概览
简要总结
This is a dose escalation study using the CyberKnife radiotherapy device for small surgical or medically untreatable renal tumors. Patients with renal tumors 5cms or less in diameter will be accrued onto this study. The ability of CyberKnife to ablate these renal tumors and maintain renal function with dose escalation will be assessed.
详细描述
The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tumor size 5 cm or less
- •Radiographic evidence of malignancy or Histologically verified primary renal malignancy.
- •If the kidney biopsy is inconclusive but the radiologist determines that the tumor based on the CT/MRI is highly suspicious for cancer, you may participate
- •Patients with highly suspicious lesions on CT or MRI
- •One -three gold fiducials placed in or around tumor
- •Contradiction or patient refusal to partial or complete nephrectomy
- •Age 18 or greater
- •KPS score 70 or greater
排除标准
- •Irreversible coagulopathies that preclude fiducial placement
结局指标
主要结局
To determine the maximum tolerated dose of CyberKnife radiation
时间窗: 2 years
次要结局
- To evaluate local control, overall survival and late toxicity including preservation of renal function(2 years)
研究者
Irving Kaplan
Assistant Professor of Radiation Oncology
Beth Israel Deaconess Medical Center