A Phase II Study to Evaluate the Effect of Dalteparin and Radiation Therapy on Survival Compared to the RTOG RPA Database and on Thromboembolic Events in Patients With Newly Diagnosed Glioblastoma Multiforme
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 24
研究概览
简要总结
RATIONALE: Dalteparin may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining dalteparin with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining dalteparin with radiation therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.
详细描述
OBJECTIVES:
- Determine whether dalteparin, initiated at the time of conventional radiotherapy, improves the median survival of patients with newly diagnosed supratentorial glioblastoma multiforme.
- Determine the time to progression in patients treated with this regimen.
- Determine the incidence of thromboembolic events in patients treated with this regimen.
- Determine the feasibility and toxicity of dalteparin in this patient population.
OUTLINE: This is a multicenter study.
Patients undergo cranial irradiation 5 days a week for 7 weeks. Beginning concurrently with initiation of radiotherapy, patients receive dalteparin subcutaneously once daily for up to 2 years in the absence of unacceptable toxicity. Patients may continue receiving dalteparin after year 2 at the discretion of the investigator.
Patients are followed every 3 months for 2 years and then every 6 months for up to 5 years after study entry.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（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