NCT00214136已完成2 期
A Phase II Prostate Cancer Trial Treating Pelvic Lymph Nodes to High Dose Using Intensity Modulated Radiation Therapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants Experiencing Expected Toxicities
研究概览
简要总结
The purpose of this study is to examine the clinical feasibility and efficacy of uing IMRT to escalate the biologically effective dose to the pelvic lymph nodes in a short course of radiation therapy. An increased total and biologically effective dose will be delivered to the pelvic lymph nodes (56 Gy at 2 Gy/fraction). The prostate will receive standard "short course" IMRT of radiation (70 Gy at 2.5 Gy/fraction).
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer stage T-T3
- •Predicted risk of lymph node involvement > 15%
- •Gleason > 7
排除标准
- •Distance metastases
- •Use of anti-coagulant therapy
结局指标
主要结局
Number of Participants Experiencing Expected Toxicities
时间窗: Up to 5 years
Tolerances to high dose RT to Pelvic Lymph nodes in treatment of prostate cancer; measured by participants experiencing expected toxicities.
次要结局
- To Evaluate Local Tumor Control and Biochemical Progression-free and Metastasis-free Survival(5 years)
研究者
研究点 (2)
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