CEV With/Without Periocular Carboplatin Chemotherapy for Nonmetastatic Extraocular Retinoblastoma Carboplatin--A Single Center, Retrospective Study to Evaluate the Efficacy of Carboplatin in Subjects With Retinoblastoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 主要终点
- Event Free Survival Rate
研究概览
简要总结
This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular retinoblastoma
详细描述
This study will be a phase 4 open label interventional case series. Patients with retinoblastoma will be receive chemotherapy with or without periocular injections of carboplatin at a dose of 20mg/2 ml. Patients will receive chemotherapy on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 18 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
- •IRSS stage II or stage IIIa RB patients.
- •for patients with IRSS stage II disease, if scleral surface invasion alone was observed, only systemic chemotherapy was administered, whereas other IRSS stage II and IIIa patients received systemic chemotherapy plus additional local chemotherapy.
- •no tumor-related treatment was given prior to this chemotherapy regimen.
排除标准
- •metastasis, including lymph node metastasis.
- •the diagnosis of IRSS stage I or above in the non-target eye.
研究组 & 干预措施
CEV with/without carboplatin
CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection
干预措施: CEV chemotherapy (Drug)
CEV with/without carboplatin
CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection
干预措施: carboplatin periocular injection (Drug)
结局指标
主要结局
Event Free Survival Rate
时间窗: 18 months
measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis
次要结局
未报告次要终点
研究者
Huasheng Yang
Huasheng Yang
Sun Yat-sen University