NCT01787630
Unknown
2 期
Initiating Phase II-III Study to Evaluate the Technique and Effects of Separating the Prostate From the Rectum With Hyaluronic Acid During Radiotherapy
Anders Widmark3 个研究点 分布在 1 个国家目标入组 81 人2010年1月
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Prostatic Cancer
- 发起方
- Anders Widmark
- 入组人数
- 81
- 试验地点
- 3
- 主要终点
- Remaining volume of HA
- 最后更新
- 9年前
概览
简要总结
The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the rectum could be completely moved out of the treated volume, a substantial decrease of rectal toxicity seems reasonable. In this study we will develop and evaluate a new transrectal injection technique where hyaluronic acid (HA) is injected in the space between the prostate and the rectum prior to external beam radiotherapy to increase the physical distance between prostate and rectum.
研究者
Anders Widmark
Professor, MD
Umeå University
入排标准
入选标准
- •Histologically verified prostatic cancer
- •Low or intermediate risk prostatic cancer
- •Lymph node negative
- •Suitable for radiotherapy
排除标准
- •Earlier treatment for prostatic cancer
- •Unable to co-operate or suffering from any other form of disease that would interfere with the planned treatment
结局指标
主要结局
Remaining volume of HA
时间窗: 24 month after end of radiotherapy
Measurement on the remaining volume of HA by MRI
次要结局
- Quality of life(24 month after end of radiotherapy)
研究点 (3)
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