Multimodal Management of stage II and III extraocular retinoblastoma : An Interventional pilot study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To estimate the Disease free survival (DFS) at 1 year after multimodal management in children less than 18 years diagnosed with stage II and III extraocular retinoblastoma
研究概览
简要总结
After applying the eligibility criteria, written informed consent shall be taken from the parent/ legally appointed representative and assent shall be taken from the child.
According to the stage of disease, child will be started on Surgery versus neoadjuvant chemotherapy
Child will then be taken up for enucleation.
Those who will undergo upfront surgery will then be started on adjuvant chemotherapy
Supportive care during and after chemotherapy administration will be optimally provided.
Child will undergo external beam radiotherapy 4-6 weeks after completion of adjuvant chemotherapy.
Child will then be followed up for a period of 1 year post treatment completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Those fulfilling the criteria for IRSS stage II and III of extraocular retinoblastoma defined previously will be included in the study.
排除标准
- •Pre-existing renal disease Pre-existing Hearing impairment Relapsed extraocular retinoblastoma.
结局指标
主要结局
To estimate the Disease free survival (DFS) at 1 year after multimodal management in children less than 18 years diagnosed with stage II and III extraocular retinoblastoma
时间窗: 12 months after treatment completion
次要结局
- To study the adverse effects using CTCAE criteria in children less(than 18 years diagnosed with stage II & III extraocular)
研究者
Shivani Deep Singh
All India Institute of Medical Sciences, New Delhi