CCLG Observational Study of the Outcome of Ependymoma in Infants Diagnosed Before Their Third Birthday
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Gathering information about how young patients with ependymoma respond to standard combination chemotherapy and learning about the long-term effects of this treatment may help doctors plan better treatment.
PURPOSE: This phase III trial is observing young patients with ependymoma undergoing standard combination chemotherapy.
详细描述
OBJECTIVES:
Primary
- To determine the overall survival and event-free survival of all infants diagnosed with ependymoma before their third birthday.
- To determine the overall survival and event-free survival of infants diagnosed with ependymoma before their third birthday when treated with standard chemotherapy comprising vincristine, carboplatin, high-dose methotrexate, cyclophosphamide, and cisplatin.
Secondary
- To investigate the reasons why the primary tumor was completely resected in patients who were able to undergo complete resection of the tumor.
- To continue to investigate the biological characteristics of ependymoma.
- To correlate functional imaging studies of ependymoma with biological characteristics of the tumor.
- To provide a standard treatment regimen for patients with residual disease after optimal surgery who have already participated in a phase II study.
- To prospectively document renal function, hearing, and neurocognitive late effects after completion of study treatment.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Overall survival
Event-free survival
Response to chemotherapy, if there is residual disease
Requirement for radiotherapy (i.e., residual disease at the completion of chemotherapy, progressive disease during chemotherapy, or recurrent disease during or after completion chemotherapy)
Late effects of treatment (i.e., ototoxicity and nephrotoxicity at the completion of chemotherapy and neurocognitive outcomes at 5, 7, 11, and 16 years of age)
次要结局
未报告次要终点