A Prospective Randomised Controlled Trial of Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Free survival rate
研究概览
简要总结
This is an international prospective randomised trial, which will compare two radiotherapy regimens in children and adolescents (aged 4 or 5 years to 21 years inclusive) with carefully staged 'standard risk' medulloblastoma.
详细描述
Patients eligible for the study will be those with non-metastatic medulloblastoma (by imaging and CSF cytology) at diagnosis. Patients randomised to the standard arm will receive conventionally fractionated (once a day) radiotherapy with a dose of 54 Gy to the posterior fossa and 23.4 Gy to the craniospinal axis. The experimental arm will be hyperfractionated (twice a day) radiotherapy (1 Gy b.d.) with a dose of 60 Gy to the posterior fossa with an additional 8 Gy to the tumour bed and 36 Gy to the craniospinal axis. Both groups will receive identical chemotherapy consisting of eight weekly doses of Vincristine given with radiotherapy and 8 courses of CCNU, cisplatin and vincristine following radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at diagnosis at least 4 years or 5 years (according to the policy of the National Brain Tumour Group) and less than 22 years.
- •Histologically proven medulloblastoma, including the following variants(WHO classification - 2000): classic medulloblastoma, nodular / desmoplastic medulloblastoma, melanotic medulloblastoma, medullomyoblastoma No CNS metastasis on MRI - supratentorial, arachnoid of the posterior fossa or spine.
- •No clinical evidence of extra-CNS metastasis
- •No tumour cells on the cytospin of lumbar CSF. Central Review of CSF cytology is recommended but not mandatory. It will be left to national policy.
- •Radiotherapy to start no more than 40 days after surgery.
- •Ability to receive twice daily radiotherapy.
- •Vital functions within normal range for their age group.
- •CTC grades < 2 for liver, renal, haematological and audiological function.
- •No medical contraindication to radiotherapy or chemotherapy.
- •Written informed consent (and patient assent where appropriate) according to the laws of each participating country. Written informed consent should also be sought for biological studies.
- •National and local ethical committee approval according to the laws of each participating country (to include approval for biological studies).
排除标准
- •One of the inclusion criteria is lacking.
- •Brainstem or supratentorial primitive neuroectodermal tumour.
- •Atypical teratoid rhabdoid tumour.
- •Medulloepithelioma.
- •Ependymoblastoma.
- •Large cell médulloblastoma.
- •Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of postoperative lumbar CSF).
- •Patient previously treated for a brain tumour or any type of malignant disease.
- •Patients who are pregnant.
- •Females who are sexually active and not taking reliable contraception.
- •Known predisposition to medulloblastoma e.g. Gorlin's syndrome.
结局指标
主要结局
Free survival rate
时间窗: 2 years after the start of the study
To compare in a randomised trial the event free survival rate for children and adolescents with standard risk medulloblastoma treated with either hyperfractionated radiotherapy or reduced dose radiotherapy with conventional fractionation.
次要结局
- To compare overall survival between the two treatment arms.(Follow-up of the last patient included up to the age of 20 years)
- To compare the pattern of relapse between the two treatment arms(Follow-up of the last patient included up to the age of 20 years)
- To explore the benefit and the risks of neurosurgery(Follow-up of the last patient included up to the age of 20 years)