Phase 2 Study of Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Medulloblastoma
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
This phase II trial is studying giving radiation therapy together with combination chemotherapy after surgery to see how well it works in treating children with newly diagnosed medulloblastoma.
详细描述
OUTLINE:
Adjuvant induction chemoradiotherapy: Beginning within 28 days after prior resection, patients undergo radiotherapy to the craniospinal axis 5 days a week for 4 weeks and then conformal radiotherapy to the tumor bed 5 days a week for 2 weeks. Beginning 1 week after the initiation of radiotherapy, Temozolomide is applied to these patients as a chemotherapy drug with a dosage of 75mg/m2, daily. The chemotherapy and radiation are combined as temozolomide is taken 1 hour prior to every fraction of radiotherapy.
Maintenance chemotherapy: Beginning 4 weeks after the completion of induction chemoradiotherapy, patients receive eight 4-week cycles of temozolomide (dosage: the 1st cycle, 150mg/m2, daily × 5 days, 4 weeks a cycle; the 2-8th cycle, 200mg/m2, daily × 5 days, 4 weeks a cycle and repeated again).
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
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
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed posterior fossa medulloblastoma
- •No residual tumor greater than 1.5 cm^2 after resection by postoperative MRI No tumor in the spinal or cerebral subarachnoid space by MRI No tumor in the subarachnoid space by Cerebrospinal fluid (CSF) No failure to perform staging studies (spine MRI and CSF cytology) preoperatively or postoperatively
- •Must begin radiotherapy on study within 28 days after surgery
排除标准
- •Prior radiotherapy and anti-tumor chemotherapy other than corticosteroids are not allowed.
- •Patients must begin radiotherapy on protocol within 28 days of completion of surgery. Exceptions need to be approved by the Principal Investigator.
- •Patients with the following will not be eligible:
- •> 1.5cm3 residual tumor following resection as indicated by post-operative MRI. tumor in spinal or cerebral subarachnoid space either by MRI of brain and spine tumor in subarachnoid space by CSF cytology failure to perform staging studies (spine MRI, CSF cytology) either pre- or post- operatively
研究组 & 干预措施
Study Treatment
All subjects will undergo routine surgical staging of their tumor. Treatment must begin within 28 days of surgery. Craniospinal Radiation therapy will last for 6 weeks, five days per week. Once a week during radiation, subjects will also be treated with Temozolomide. Temozolomide is applied to these patients as a chemotherapy drug with a dosage of 75mg/m2, daily. The chemotherapy and radiation therapy are combined as Temozolomide is taken 1 hour prior to every fraction of radiotherapy. In 4 weeks after the completion of radiotherapy, temozolomide is given for 8 cycles.
干预措施: Temozolomide (Drug)
Study Treatment
All subjects will undergo routine surgical staging of their tumor. Treatment must begin within 28 days of surgery. Craniospinal Radiation therapy will last for 6 weeks, five days per week. Once a week during radiation, subjects will also be treated with Temozolomide. Temozolomide is applied to these patients as a chemotherapy drug with a dosage of 75mg/m2, daily. The chemotherapy and radiation therapy are combined as Temozolomide is taken 1 hour prior to every fraction of radiotherapy. In 4 weeks after the completion of radiotherapy, temozolomide is given for 8 cycles.
干预措施: Craniospinal Radiation (Radiation)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: first analysis will occur 1 month after accrual of all patients
次要结局
- Progression free survival(PFS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Overall survival (OS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Evaluate Rate of Late Neurotoxic Effects(3 years)
研究者
Chuanying Zhu
doctor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine