Carboplatin Periocular Injection in the Treatment for Retinoblastoma--A Single Center, Randomized Study to Evaluate the Efficacy of Carboplatin in Subjects With Retinoblastoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- all cause mortality
研究概览
简要总结
This study will evaluate the clinical efficacy of periocular injections of carboplatin together with chemotherapy in the treatment of Retinoblastoma as compared to chemotherapy alone.
详细描述
This study will be a phase Ⅲ open label interventional case series. Patients with retinoblastoma will be randomized to receive chemotherapy with or without periocular injections of carboplatin at a dose of 20mg/2 ml. Patients will receive carboplatin periocular on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 24 months .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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.
- •linical diagnosis of retinoblastoma, Stage 0 or Ⅱ base on International Retinoblastoma Staging System.
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
carboplatin periocular injection
20mg/2ml carboplatin periocular injection together with CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months)
干预措施: carboplatin periocular injection (Drug)
chemotherapy
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months
干预措施: chemotherapy (Drug)
结局指标
主要结局
all cause mortality
时间窗: two years
measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years
次要结局
- side effects of carboplatin periocular injection in the Treatment of Retinoblastoma(two years)
研究者
Huasheng Yang
professor
Sun Yat-sen University