NCT00963404已完成1 期
Image-guided Tumorboost of Localized Unifocal Bladder Cancer: A Phase I/II Study
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 8
- 主要终点
- Local tumor control
研究概览
简要总结
The purpose of the study is to increase the radiation dose (Boost) to the bladder tumor. The bladder cancer patients included in the study will undergo tumor demarcation. The bladder demarcations will then be the target for an image-guided boost delivered precisely to the expected tumor site.
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
- •Muscle invasive bladder cancer (transitional carcinoma)
- •TNM stage T2a-4a, N0-1, M0
- •unfit for radical cystectomy
排除标准
- •Hyperthyroidism
- •Multinodular goiter
- •Pregnancy
- •Breast feeding
- •WHO preformance status more than 2
- •Iodine allergy
- •MRI or CT contrast media allergy
- •Bi-lateral hip-prosthesis
研究组 & 干预措施
Tumor-boost
Experimental
Image-guided tumorboost of the bladder cancer.
干预措施: Radiation boost (Radiation)
结局指标
主要结局
Local tumor control
时间窗: One year
次要结局
- Acute and late adverse effects of the radiotherapy treatment(3 years)
研究者
研究点 (8)
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