临床试验/NCT00214136

NCT00214136已完成2 期

A Phase II Prostate Cancer Trial Treating Pelvic Lymph Nodes to High Dose Using Intensity Modulated Radiation Therapy

University of Wisconsin, Madison1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2005年3月1日最近更新: 2021年8月4日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: University of Wisconsin, Madison
入组人数: 30
试验地点: 1
主要终点: Number of Participants Experiencing Expected Toxicities

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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

研究组 & 干预措施

1

Experimental

prostate radiation to 70Gy, lymph nodes to 56Gy

干预措施: radiotherapy (Radiation)

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

发起方

University of Wisconsin, Madison

申办方类型

Other

责任方

Sponsor

研究点 (1)

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