NCT00114985已完成2 期
A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Rectal toxicity at six month intervals
研究概览
简要总结
During 3D-conformal external beam radiation therapy treatments for prostate cancer, the prostate gland moves. The purpose of this study is to determine whether the placement of a prostate immobilization device into the rectum during radiation treatments will decrease the risk of rectal bleeding that is sometimes seen as a late effect from radiation.
详细描述
- MRI using an endorectal coil done prior to treatment for staging.
- Baseline Quality of Life (QOL) assessment will be completed prior to treatment.
- Total androgen suppression is initiated and will continue for at least 6 months.
- Prostate Immobilization Device (PID) placed during the planning session.
- PID will be placed daily for the first 15 3D external beam radiation treatments.
- QOL assessment and follow-up will take place every 6 months for 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 31 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven prostate cancer
- •Clinical Stage T1 - T4
- •Negative bone scan
- •PSA and routine blood work
- •>30 years of age
- •ECOG Performance 0,1, or 2
- •No prior pelvic radiation
- •No pacemaker
排除标准
- •Inflammatory bowel disease (Crohns, or Ulcerative Colitis)
- •Prostatic rectal fistula
- •Stricture of anal canal
结局指标
主要结局
Rectal toxicity at six month intervals
时间窗: 2 years
次要结局
- urinary symptoms(2 years)
- Quality of Life(2 years)
- sexual dysfunction at six month intervals(2 years)
研究者
Anthony V. D'Amico, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute
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