A Phase II, Multicenter, Study for Newly Diagnosed Glioblastomas Using Boron Neutron Capture Therapy, Additional X-ray Treatment and Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
RATIONALE: Boron neutron capture therapy and radiation therapy use high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving boron neutron capture therapy followed by radiation therapy and temozolomide may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving boron neutron capture therapy together with radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme.
详细描述
OBJECTIVES:
- Evaluate the overall survival of patients with newly diagnosed glioblastoma multiforme treated with boron neutron capture therapy, radiotherapy, and concurrent and adjuvant temozolomide.
- Evaluate tumor response in patients treated with this regimen.
- Evaluate the adverse effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo boron neutron capture therapy followed by radiotherapy and concurrent and adjuvant oral temozolomide.
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
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 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
研究组 & 干预措施
Treatment group
BNCT(boron neutron capture therapy), XRT(X-ray radiation treatment) and TMZ(temozolomide) treatment
干预措施: BNCT(boron neutron capture therapy) (Radiation)
Treatment group
BNCT(boron neutron capture therapy), XRT(X-ray radiation treatment) and TMZ(temozolomide) treatment
干预措施: XRT(X-ray radiation treatment) (Radiation)
Treatment group
BNCT(boron neutron capture therapy), XRT(X-ray radiation treatment) and TMZ(temozolomide) treatment
干预措施: TMZ(temozolomide) (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Time to death from BSH injection（up to 6 years）
次要结局
- Tumor response（RECIST）(From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks)
- Disease Control Rate (DCR)(From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks)
- Objective Response Rate (ORR)(From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks)
- Adverse event(Time to final follow-up survey from the date of enrollment)