A Randomized Phase III Study of Re-Irradiation in Recurrent Glioblastoma
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To determine the overall median survival of the combination of continuous dose-intense temozolomide with or without re-irradiation in patients with recurrent glioblastoma.
研究概览
简要总结
The investigators hope to improve overall median survival of patients with recurrent Glioblastoma by investigating continuous low-dose daily Temozolomide plus or minus five treatments of re-irradiation.
详细描述
This is a stratified study for patients with recurrent intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation presenting radiographic progression or recurrence of tumour. Patients are stratified by extent of resection, time to re-irradiation and re-irradiation volume.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically-proven intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation
- •radiographic evidence of tumour progression or recurrence
- •18 years or older
- •ECOG 0 - 2
- •signed informed consent form
排除标准
- •tumour progression or recurrence within 3 months of initial concurrent chemoradiation
- •6 or more cycles of TMZ administered following chemoradiation at initial diagnosis
- •more than one prior course of salvage chemo for recurrent disease
- •prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for greater or equal to 3 years
- •prior head or neck RT except for T1 glottic cancer
研究组 & 干预措施
TMZ plus concurrent re-irradiation
TMZ plus concurrent re-irradiation
干预措施: TMZ plus concurrent re-irradiation (Drug)
TMZ alone
TMZ alone
干预措施: Temozolomide (Drug)
TMZ plus concurrent re-irradiation
TMZ plus concurrent re-irradiation
干预措施: Temozolomide (Drug)
TMZ alone
TMZ alone
干预措施: TMZ plus concurrent re-irradiation (Drug)
结局指标
主要结局
To determine the overall median survival of the combination of continuous dose-intense temozolomide with or without re-irradiation in patients with recurrent glioblastoma.
时间窗: 2 months
次要结局
- To evaluate time to radiographic progression or recurrence of tumour following treatment with continuous dose-intense temozolomide with or without re-irradiation.(2 months)