NCT05080010招募中3 期
Three Cycles of Adjuvant Chemotherapy for the Patients With High-risk Retinoblastoma After Enucleation: Prospective Study
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
The purpose of this study is to determine the effect of 3 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated retinoblastoma.
详细描述
This study will be a phase Ⅲ open label interventional case series. Patients with Stage I enucleated retinoblastoma will receive 3 cycles of chemotherapy(CEV) oon a monthly basis. Patients will be followed for 60 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- •Definite pathology signs of retinoblastoma, Stage I base on International Retinoblastoma Staging System.
- •Received enucleation in the study eye.
- •Monocular retinoblastoma.
排除标准
- •Any previous disease in the study eye.
- •Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
- •History of chemical intervention for retinoblastoma in the study eye.
研究组 & 干预措施
3 cycles chemotherapy
Experimental
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.
干预措施: 3 cycles chemotherapy (Drug)
结局指标
主要结局
disease-free survival
时间窗: five years
measure the disease-free survival rate at five years
次要结局
未报告次要终点
研究者
Huasheng Yang
Sun Yat-sen University
Sun Yat-sen University
研究点 (1)
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