NCT02874040已完成不适用
Phase II Evaluating Endoresection of the Tumor Scar or Transpupillary Thermotherapy When Endoresection is Not Feasible After Proton Beam Therapy for the Treatment of Large Uveal Melanomas
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Post-treatment complication incidence.
研究概览
简要总结
Study the efficacy of endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar to prevent neovascular glaucoma and secondary enucleation
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Tumor of 7 mm of thickness or more
- •Patients treated by proton beam therapy
- •Patients aged at least 18 years
- •Patients clearly informed of the study, having received the letter of information and signed the consent
排除标准
- •Massive extrascleral extension posterior to the equator
- •Patients with metastasis at diagnosis.
- •Patients with glaucoma before the radiation therapy
- •Patients with opaque media preventing transpupillary thermotherapy
- •Patients for whom follow up will be difficult due to geographical, social or psychological reasons
结局指标
主要结局
Post-treatment complication incidence.
时间窗: 3 years
observed complications are : Number of glaucomas, numbrer of retinal detachment and number of secondary enucleations.
次要结局
- Measure of tumor scar thickness(3 years)
- Toxicity and side effects evaluation according to NCI-CTCAE v4.0 scale(3 years)
研究者
研究点 (2)
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