NCT00872391Unknown不适用
Safety and Efficacy of Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Malignant Melanoma of the Uvea
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- local tumor control (tumor dimensions; secondary complications; visual acuity; survival
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of hypofractionated stereotactic LINAC radiotherapy with 10 fractions at 6 Gy per fraction at the 80% isodose for the planning target volume (PTV) in patients with uveal melanoma. Patients will be followed-up for 10 years after radiotherapy regarding local tumor control, visual acuity, secondary complications and survival.
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
- •The initial height of the melanoma is 7 mm or higher.
- •Juxtapapillary and/or juxtamacular melanomas with a height of 3 mm or higher and if the central tumor distance to the optic disc and/or the macula is 3 mm or less.
- •If other forms of conservative treatment of the melanoma are not possible.
排除标准
- •Prior/Concomitant Treatment.
- •Extrascleral tumor extension is present.
- •If the presence of neovascular glaucoma is detected before treatment.
- •If metastasis is detected at baseline.
- •Previous participation in any study of investigational drugs within 3 month preceding day
- •Pregnant women are not allowed to participate in the study.
结局指标
主要结局
local tumor control (tumor dimensions; secondary complications; visual acuity; survival
次要结局
- histological assessment of the fraction of living cells in eyes requiring secondary enucleation
研究者
研究点 (2)
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