A Phase II Study Of Radiation Therapy Plus Low Dose Temozolomide Followed By Temozolomide Plus Irinotecan For Glioblastoma Multiforme
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 118
- 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, such as temozolomide and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well radiation therapy, temozolomide, and irinotecan work in treating patients with newly diagnosed glioblastoma multiforme.
详细描述
OBJECTIVES:
- Compare overall survival of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy and temozolomide followed by temozolomide and irinotecan with historical controls from the RTOG database.
- Determine the short- and long-term toxicity of this regimen in these patients.
- Determine progression-free survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Chemoradiotherapy: Patients undergo radiotherapy once daily, 5 days a week, for 6 weeks. Concurrently with radiotherapy, patients receive oral temozolomide once daily, 7 days a week, for 6 weeks.
- Post-radiotherapy chemotherapy: Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive irinotecan IV on days 1 and 15 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 2 years and then every 6 months thereafter.
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
- 18 Years 至 —（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
RT with chemotherapy + post-radiation chemotherapy
Radiation therapy (RT) with concurrent chemotherapy + post-radiation chemotherapy
干预措施: irinotecan hydrochloride (Drug)
RT with chemotherapy + post-radiation chemotherapy
Radiation therapy (RT) with concurrent chemotherapy + post-radiation chemotherapy
干预措施: temozolomide (Drug)
RT with chemotherapy + post-radiation chemotherapy
Radiation therapy (RT) with concurrent chemotherapy + post-radiation chemotherapy
干预措施: adjuvant therapy (Procedure)
RT with chemotherapy + post-radiation chemotherapy
Radiation therapy (RT) with concurrent chemotherapy + post-radiation chemotherapy
干预措施: radiation therapy (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 randomization to date of progression, death, or last follow-up. Analysis occurs at the same time as the primary outcome analysis.)