Palliative Re-irradiation for Progressive Diffuse Intrinsic Pontine Glioma (DIPG) in Children
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- delaying disease progression
研究概览
简要总结
Although DIPG is not curable, re-irradiation with a modest total dose and short treatment time provides good palliation of symptoms, improves quality of life, delays disease progression and has minimal and manageable toxicity.
Treatment plan:
At progression, full radiological and clinical documentation necessary including a neurological exam by a neurologist will be done. Progressive patients will be referred to radiotherapy.
Radiation guidelines:
30.6 Gray (Gy) will be applied in 1.8 to 2Gy fractions in conformal radiation to tumor bed. Radiation will be done in standard accelerators and according to standard guidelines used in treatment for all brain tumor patients.
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
- 年龄范围
- 1 Year 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:1 year-22 years
- •Patient/parent consent
- •Diagnosis of DIPG based on short classic history, clinical signs (long tract signs, cranial nerve deficits and ataxia) and classic MRI features (more than 2/3 of the tumor is located within the pons and tumor encompasses more than 60% of the pons)
- •A patient will be eligible for reirradiation if progression is diagnosed following a period of at least 4 months of stable disease after first irradiation.
- •Progression may be either clinical (new neurological deficit or worsening of an old deficit in two separate physical examinations) or radiological (tumor growth of >25%)
排除标准
- •Radiation necrosis post first irradiation
- •Unstable vital signs
- •Less than X months since previous irradiation
结局指标
主要结局
delaying disease progression
时间窗: 1 year
clinical progression: close follow up including biweekly neurological assessments to evaluate for clinical progression. any onset of a new neurological deficit or deterioration of an existing deficit will require follow up within one week. persistent deficit will be considered clinical progression. progression on imaging: MRI will be done every 3 months. tumor growth of \>25% will be considered disease progression
次要结局
- improving symptoms(1 year)