Prospective Study of Stereotactic Radiosurgery Using Diffusion-Weighted Abnormality Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-line Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
This clinical trial is a prospective study of radiosurgery treatment for progressive GBM to test 1)the efficacy of radiosurgery for recurrent/progressive GBM compared to chemotherapy , and 2) the role of diffusion-weighted image (DWI) to predict the early tumor progression and treatment response.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven intracranial glioblastoma multiforme with pathologic or imaging confirmation of tumor progression or regrowth after failure of two previous treatment regimens
- •Initial low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma
- •History and physical exam, including neurologic examination, within 4 weeks prior to registration
排除标准
- •Warfarin or LMW heparin patients must have no active bleeding or pathological condition that carries a high risk of bleeding
研究组 & 干预措施
Fractionated Radiosurgery and Bevacizumab
FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression
干预措施: Bevacizumab (Drug)
Fractionated Radiosurgery and Bevacizumab
FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression
干预措施: Chemotherapy (Drug)
Fractionated Radiosurgery and Bevacizumab
FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression
干预措施: Fractionated radiosurgery (Radiation)
Bev with Chemo
Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression
干预措施: Bevacizumab (Drug)
Bev with Chemo
Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 12 months
Overall Survival
时间窗: 12 months
Local Tumor Control
时间窗: 2 months
次要结局
未报告次要终点
研究者
Salim Siddiqui, MD, PhD
Radiation Oncologist
Henry Ford Health System