Randomized Trial Assessing the Significance of Bevacizumab in Recurrent Grade II and Grade III Gliomas - The TAVAREC Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 39
- 主要终点
- Probability of survival at 1 year
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether temozolomide is more effective when given with or without bevacizumab in treating patients with recurrent glioma.
PURPOSE: This randomized clinical trial is studying how well temozolomide works with or without bevacizumab in treating patients with recurrent glioma.
详细描述
OBJECTIVES:
Primary
- To document the activity of both combination temozolomide plus bevacizumab and temozolomide alone in patients with recurrent grade II or grade III glioma without 1p/19q co-deletion.
Secondary
- To characterize the safety of treatment in these patients.
- To document the quality of life and cognitive functioning, as a measure of clinical benefit, of these patients.
- To explore qualification or occurrence of prognostic and/or predictive biomarkers of activity or efficacy in these patients. (exploratory)
- To document the discordances between RANO and Macdonald's criteria for the evaluation of response and progression. (exploratory)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Temozolomide
Administered orally on day 1-5, 150-200 mg/m(2), repeated every 4 weeks, up to 12 cycles
干预措施: Temozolomide (Drug)
Temozolomide + Bevacizumab
TMZ: Administered orally on day 1-5, 150-200 mg/m(2), repeated every 4 weeks, up to 12 cycles
Beva: 10 mg/kg bw IV in 90 minutes on day 1 and 14, 4 week cycles.
干预措施: Bevacizumab (Biological)
Temozolomide + Bevacizumab
TMZ: Administered orally on day 1-5, 150-200 mg/m(2), repeated every 4 weeks, up to 12 cycles
Beva: 10 mg/kg bw IV in 90 minutes on day 1 and 14, 4 week cycles.
干预措施: Temozolomide (Drug)
结局指标
主要结局
Probability of survival at 1 year
时间窗: From the date of randomization up to the date of death, assessed up to 12 months
Patients alive at 12 months
次要结局
- Objective response rate and duration of response(From the date of randomization until disease progression)
- Progression-free survival(From the date of randomization until the date of objective progression or the date of patient's death whichever occurs first)
- Overall survival and survival at 24 months(From the date of randomization up to the date of death)
- Safety(After the first ten patients in each arm have completed the first two cycles or have stopped treatment, an interim safety review of those patients will be conducted.)
- Clinical/neurological deterioration-free survival(From the date of randomization until the date of neurological deterioration)
- Steroid use(At baseline and every 3 months untill lost to follow-up)
- Quality of life of patients and caregivers/relatives(At baseline and every 3 months untill lost to follow-up)
- Cognitive deterioration(At baseline and every 3 months untill lost to follow-up)