ACTRN12611000749909招募中4 期
A randomised study of image guided radiotherapy (IGRT) for prostate carcinoma with and without endorectal balloon to compare treatment related morbidity and quality of life.
Professor Eric Yeoh0 个研究点目标入组 140 人开始时间: 2011年7月18日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •Localised prostate cancer T1a - T3b, N0, M0
- •Any gleason score
- •PSA equal to or less than 30 micrograms/L
- •Signed informed consent
排除标准
- •-Metastatic cancer of the prostate or disease involving organs such as the bladder and rectum - T4, N0,M0
- •-ECOG equal to or greater than 3.
- •-Constant requirement for medication likely to interfere with evaluation of anorectal motility such as anti-diarrhoeal or opiate analgesic drugs.
- •-Haemorrhoids greater than or equal to grade II (as evaluated using Common Terminology Criteria for Adverse Events V3.0
- •-Colitis equal to or greater than Grade II (as evaluated using Common Terminology Criteria for Adverse Events V3.0
- •-Any other anorectal disease that the clinician feels would interfere with the tolerance of the ERB during IGRT such as fissures, fistulas or abscesses.
- •-Previous radiation therapy to the pelvis.
- •- No signed informed consent
研究者
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