Phase II Trial of Temozolomide in Elderly Patients With Glioblastoma and Poor Performance Status (KPS<70).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The management of glioblastoma in elderly patients with poor performance status (KPS<70) is unsettled. This single arm phase 2 trial trial was designed to evaluate the efficacy and safety of temozolomide alone in this population
详细描述
This trial was conducted to evaluate the efficacy, in terms of survival and quality of life, and safety of up-front temozolomide in elderly GBM patients with poor performance status.
Patients of 70 years of age or older were eligible to participate in this prospective non-randomised multicentric phase II study if they had newly diagnosed and histologically proven glioblastoma on the basis of the WHO classification, and a postoperative KPS between 30 and 60.
Treatment consisted of temozolomide 150-200 mg/m2/day for 5 consecutive days every 4 weeks for a maximum of 12 cycles or until disease progression or prohibited toxicity.
Patients were assessed at least every month by means of physical and neurological examinations, KPS, health-related EORTC questionnaires (QLQ-C30 and QLQ-BN20), and MMSE. Complete blood counts and blood chemistry were drawn before each temozolomide cycle; the earlier were also checked every 10 days during the first 2 cycles and every 2 weeks afterwards. CT or MRI studies were repeated every 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed supratentorial glioblastoma
- •Baseline contrast-enhanced CT or gadolinium-enhanced MRI study performed within the first 4 days from resection or within the first 4 weeks from diagnostic biopsy
- •Patients aged 70 years or older
- •KPS above 30 and below 70
- •Life expectancy higher than 4 weeks
- •Clinical examination at baseline
- •Affiliation to Social Security or mandatory beneficiary
- •Patient being informed and obtention of written informed consent
排除标准
- •Prior surgical resection dated more than 1 month before inclusion
- •Prior brain radiotherapy or chemotherapy
- •Severe underlying disease which could interfere with survival
- •History of hypersensibility reaction on temozolomide components
- •Severe bone marrow hypoplasia
- •Aspartate aminotransferase or alanine aminotransferase more than 3 times the upper limit of normal
- •Absolute neutrophil count < 1.5x109 cells per liter
- •Platelet count < 100x109 cells per liter
- •Hemoglobin < 9 g/dl
- •Neuroimaging baseline examination performed beyond the first 4 days from resection or beyond the first 4 weeks from diagnostic biopsy
研究组 & 干预措施
temozolomide
Administration of temozolomide 150-200 mg/m2/day for 5 consecutive days every 4 weeks for a maximum of 12 cycles or until disease progression or prohibited toxicity
干预措施: Temozolomide (Drug)
结局指标
主要结局
Overall survival
时间窗: 12 months
次要结局
- Progression-free survival(12 months)
- adverse events(12 months)
- Health-related quality of life(12 months)
- Cognitive functioning(12 months)
- Efficacy according to MGMT Promoter methylation status(12 months)