NCT01493206已完成2 期
A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer
Peter MacCallum Cancer Centre, Australia2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2004年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- clinical outcomes
研究概览
简要总结
The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal cancer improve outcomes without causing significant side effects.
详细描述
Primary Outcome measures are 3-year locoregional control, progression-free and overall survival rates.
Secondary outcome measures are toxicities scores up to 3 months after surgery (acute) and greater than 3 months after surgery (late). Data collected at 3-6 month intervals for 30 months
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
- All
- 接受健康志愿者
- 否
入选标准
- •locally advanced or recurrent rectal cancer
- •suitable for radical surgery but at high risk of positive resection margins,
- •no evidence of metastasis,
- •age greater than 18 years,
- •histologically confirmed adenocarcinoma,
- •ECOG performance status <
- •Informed consent
排除标准
- •unresectable pelvic disease
- •distant metastasis
- •significant co-morbidities
结局指标
主要结局
clinical outcomes
时间窗: 3-year
locoregional control, progression-free and overall survival rates.
次要结局
- toxicities(3-6 monthly up to 30 months)
研究者
研究点 (2)
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