NCT00445757撤回1 期
Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose of radiation
研究概览
简要总结
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with kidney tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of radiation in patients undergoing stereotactic radiotherapy for renal tumors.
- Determine radiotherapy-associated toxicity in these patients.
Secondary
- Determine preoperative pathologic response to this regimen in these patients.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose of radiation
时间窗: DLT is assessed at 4 and 8 weeks after radiotherapy
Radiotherapy-associated toxicity
时间窗: DLT is assessed at 4 and 8 weeks after radiotherapy
次要结局
- Disease-specific survival(follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery)
- Disease-free survival(follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery)
- Time to local progression(follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery)
- Time to distant failure(follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery)
- Survival(follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery)
研究者
研究点 (2)
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