Vincristine and Topotecan versus Carboplatin, Etoposide and Vincristine based chemotherapy for ocular salvage in Gr D Intraocular Retinoblastoma: a randomised, open label trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare treatment failure rate between Vincristine and Topotecan (VT)
研究概览
简要总结
patients will be divided into two groups based on randomisation and they will receive one of the two treatment arms based on allocation. after two cycles of chemotherapy they will undergo evaluation under anaesthesia to look for tumour regression. After 6 cycles of chemotherapy children in both group will be compared for ocular salvage and toxicity
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All cases of newly diagnosed Unilateral Group D Intraocular Retinoblastoma
- •All cases of newly diagnosed bilateral Intraocular Retinoblastoma with at least one eye with Group D Intraocular Retinoblastoma
- •Age less than 12 years.
排除标准
- •1.Received any prior anti-neoplastic or local ophthalmic therapy
- •Group E Intraocular retinoblastoma
- •Relapsed cases.
结局指标
主要结局
To compare treatment failure rate between Vincristine and Topotecan (VT)
时间窗: To compare treatment failure rate between Vincristine and Topotecan (VT) | combination and Carboplatin, Etoposide and Vincristine (CEV) combination | chemotherapy after 6 cycles of chemotherapy in children aged less than 12 years with Group | D Intraocular retinoblastoma
combination and Carboplatin, Etoposide and Vincristine (CEV) combination
时间窗: To compare treatment failure rate between Vincristine and Topotecan (VT) | combination and Carboplatin, Etoposide and Vincristine (CEV) combination | chemotherapy after 6 cycles of chemotherapy in children aged less than 12 years with Group | D Intraocular retinoblastoma
chemotherapy after 6 cycles of chemotherapy in children aged less than 12 years with Group
时间窗: To compare treatment failure rate between Vincristine and Topotecan (VT) | combination and Carboplatin, Etoposide and Vincristine (CEV) combination | chemotherapy after 6 cycles of chemotherapy in children aged less than 12 years with Group | D Intraocular retinoblastoma
D Intraocular retinoblastoma
时间窗: To compare treatment failure rate between Vincristine and Topotecan (VT) | combination and Carboplatin, Etoposide and Vincristine (CEV) combination | chemotherapy after 6 cycles of chemotherapy in children aged less than 12 years with Group | D Intraocular retinoblastoma
次要结局
- 1. To compare vision salvage in both the groups(2. To compare the toxicity profile between both the groups)