A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts For Supratentorial Glioblastoma Multiforme
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 236
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by carmustine in treating patients who have supratentorial glioblastoma multiforme.
详细描述
OBJECTIVES:
- Determine the overall and progression-free survival in patients with supratentorial glioblastoma multiforme treated with accelerated radiotherapy and conformal stereotactic radiotherapy boost followed by carmustine.
- Determine the short and long-term toxicity of this regimen in these patients.
- Determine the feasibility of this regimen in these patients.
OUTLINE: Patients receive daily accelerated radiotherapy 5 days a week on weeks 1-2. On weeks 3-6, patients receive accelerated radiotherapy 4 days a week (3 days a week on week 6) and conformal stereotactic radiotherapy boost once weekly. Patients then receive carmustine IV over 1-2 hours on days 1-3 every 8 weeks for 6 courses beginning within 1 month after the completion of radiotherapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within 15 months.
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
- 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
External beam radiotherapy with stereotactic boost
External beam radiotherapy (EBXRT): 50 Gy in 25 daily fractions of 2 Gy. Stereotactic radiotherapy (SRT) boost: 4 treatments of 5 or 7 Gy, once per week during weeks 3-6. Patients will not receive EBXRT on the SRT treatment days.
干预措施: carmustine (Drug)
External beam radiotherapy with stereotactic boost
External beam radiotherapy (EBXRT): 50 Gy in 25 daily fractions of 2 Gy. Stereotactic radiotherapy (SRT) boost: 4 treatments of 5 or 7 Gy, once per week during weeks 3-6. Patients will not receive EBXRT on the SRT treatment days.
干预措施: radiation therapy (Radiation)
External beam radiotherapy with stereotactic boost
External beam radiotherapy (EBXRT): 50 Gy in 25 daily fractions of 2 Gy. Stereotactic radiotherapy (SRT) boost: 4 treatments of 5 or 7 Gy, once per week during weeks 3-6. Patients will not receive EBXRT on the SRT treatment days.
干预措施: stereotactic radiosurgery (Radiation)
结局指标
主要结局
Overall Survival
时间窗: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.
次要结局
- Progression-free Survival(From registration to date of progression, death or last follow-up. Analysis occurs at the same time as the primary outcome analysis.)