A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 182
- 主要终点
- Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months
研究概览
简要总结
This 2 arm study will compare the effect of Avastin + irinotecan versus temozolomide, in combination with conventional involved field radiotherapy, in patients with newly diagnosed glioblastoma and a non-methylated MGMT promoter. Patients will be randomized 3:1 to receive Avastin 10mg/kg iv every 2 weeks + irinotecan 125mg/m2 iv every 2 weeks, or temozolomide 75mg/m2 po daily during radiotherapy followed by 6 cycles of temozolomide 150-200mg/m2 po daily on days 1-5 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-70 years of age;
- •glioblastoma, confirmed histologically;
- •no previous chemotherapy or radiotherapy for glioblastoma;
- •non-methylated MGMT promoter in the tumor.
排除标准
- •prior systemic treatment for glioblastoma multiforme;
- •prior treatment with Avastin;
- •significant cardiovascular disease;
- •other active malignant disease.
研究组 & 干预措施
1
干预措施: bevacizumab [Avastin] (Drug)
1
干预措施: irinotecan (Drug)
2
干预措施: temozolomide (Drug)
结局指标
主要结局
Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months
时间窗: 6 months
Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first. Progression was defined as 25 percent (%) increase in size of enhancing tumor or any new tumor on gadolinium contrast agent magnetic resonance imaging (Gd-MRI) scans, or neurologically worse, and steroids stable or increased. Percentage of participants achieving PFS without disease progression or death was reported.
次要结局
- Progression-Free Survival (PFS)(From baseline to the end of the study (up to 4.5 years))
- Time to Treatment Failure(From baseline until end of study (up to 4.5 years))
- Overall Survival (OS)(From baseline until death (up to 4.5 years))
- Percentage of Participants Who Discontinued(From baseline until death (up to 4.5 years))
- Number of Participants With A Best Overall Response (BOR) of Complete Response (CR) and With A BOR of CR or Partial Response (PR)(4 week after radiotherapy (RT) (up to Week 4), >4 Week after RT (up to Week 8) and Month 6)
- Percentage of Participants With Response on FLAIR Imaging(At screening, Baseline, Month 6 and Therapy Discontinuation (Up to 4.5 years))
- Change From Baseline for Mini-Mental Status Examination (MMSE) at Baseline, Post-Baseline (up to Month 30)(Baseline, Post-Baseline (up to Month 30))
- Percentage of Participants Who Received Corticosteroid for Glioblastoma(From baseline to Month 6)
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ - C30) at Baseline, Post-Baseline (up to Month 30)(Baseline, Post-Baseline (up to Month 30))
- Change From Baseline for Karnofsky Performance Status (KPS) Score at Baseline, Post-Baseline (up to Month 30)(Baseline, Post-Baseline (up to Month 30))
- Change From Baseline for EORTC QLQ Brain Neoplasm 20 (BN20) at Baseline, Post-Baseline (up to Month 30)(Baseline, Post-Baseline (up to Month 30))