NCT02842723已完成2 期
Phase II Study on the Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy
研究概览
简要总结
Prospective, open labelled, phase II, monocenter trial to combine partial surgery resection and protontherapy to management paediatric craniopharyngioma.
详细描述
This study is phase II prospective, open labelled, phase ii, monocenter. The main objective is to evaluate the fractionated high precision radiotherapy with a dose of 59,5 Gy (1,7 Gy daily, 5 fractions per week).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically documented craniopharyngioma
- •Age range between 3 and 16 years
- •Landsky performance status > 60
- •Incomplete surgical resection or simple biopsy
- •Solid and/or cystic aspect on imaging
- •Irradiation performed at the time of presentation or of local progression
- •Signed informed consent by parents or by legal representative (with copy to each participating center)
排除标准
- •Previous history of radiotherapy (including stereotactic) administered to the head and neck region
- •Severe vasculopathy
- •Participation to a concurrent study
- •Contra-indication to general anesthesia in children below 5 years
- •Patient non-compliant to a minimum 30 mn immobilisation
- •Patient deprived of freedom or under guardianship
- •Patient not expected to be followed in a long run
结局指标
主要结局
local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy
时间窗: at 3 years
次要结局
- visual pathway tolerance according to NCI-CTC v3.0 scale(through study completion, up to 9 years)
研究者
研究点 (6)
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