A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 39
- 主要终点
- Rate of progression at 6 months (post-chemotherapy/pre-irradiation progression)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation therapy in treating patients who have newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas.
详细描述
OBJECTIVES:
- Determine the rate of progression in patients with newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas treated with neoadjuvant and concurrent temozolomide with radiotherapy.
- Determine the toxicity of this regimen in these patients.
- Determine the survival of patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to response to neoadjuvant temozolomide (stable disease or partial response (PR) vs complete response (CR)).
Patients receive oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive 2 courses beyond CR or PR.
Within 6 weeks after completion of neoadjuvant temozolomide, patients with stable disease or PR undergo radiotherapy 5 days a week for 6.5 weeks. Patients also receive oral temozolomide daily for 42 days concurrently with radiotherapy.
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 65 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
研究组 & 干预措施
Pre-RT temozolomide, RT plus temozolomide
Pre-radiation therapy (RT) temozolomide, RT plus temozolomide
干预措施: temozolomide (Drug)
Pre-RT temozolomide, RT plus temozolomide
Pre-radiation therapy (RT) temozolomide, RT plus temozolomide
干预措施: neoadjuvant therapy (Procedure)
Pre-RT temozolomide, RT plus temozolomide
Pre-radiation therapy (RT) temozolomide, RT plus temozolomide
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Rate of progression at 6 months (post-chemotherapy/pre-irradiation progression)
时间窗: From start of treatment to 6 months
次要结局
- Overall Survival(From registration to date of death or last follow-up)