A Phase III Comparison of Hyperfractionated Radiation Therapy (RT) With BCNU and Conventional RT With BCNU for Supratentorial Malignant Glioma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 712
- 主要终点
- Overall Survival
研究概览
简要总结
Hyperfractionated radiation therapy (RT) to 72.0 Gy with BCNU will be compared to conventional radiation therapy to 60.0 Gy with BCNU to determine if hyperfractionated RT can improve the median survival time of adults with supratentorial malignant gliomas.
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
- •Histopathologically confirmed glioblastoma multiforme (with areas of necrosis), malignant astrocytoma and astrocytoma with foci of anaplasia
- •Karnofsky Performance Score ≥ 60
- •Absolute Neutrophil count ≥ 1,500
- •Platelets ≥ 100,000
- •Creatinine ≤ 1.5
- •Bilirubin ≤ 2.0
- •Hemoglobin ≥ 10 gm
- •SGOT < 2 x upper limit of normal
- •SGPT < 2 x upper limit of normal
排除标准
- •No prior radiation to the head or neck area, chemotherapy or radiosensitizer
- •No malignancy with the past five years except non-melanomatous skin cancer or carcinoma in-situ of the cervix
研究组 & 干预措施
Arm 1: Conventional RT + Carmustine
Conventional RT: 60.0 Gy/30 fractions/2.0 Gy once daily + carmustine 80 mg/m2 IV on Days 1, 2, 3 of RT then every 8 weeks for 6 cycles
干预措施: Conventional RT (Radiation)
Arm 1: Conventional RT + Carmustine
Conventional RT: 60.0 Gy/30 fractions/2.0 Gy once daily + carmustine 80 mg/m2 IV on Days 1, 2, 3 of RT then every 8 weeks for 6 cycles
干预措施: Carmustine (Drug)
Arm 2: Hyperfractionated RT + Carmustine
Hyperfractionated RT: 72.0 Gy/60 fractions/6 weeks/1.2 Gy BID + carmustine 80 mg/m2 IV on Days 1, 2, 3 of RT and then every 8 weeks for 6 cycles
干预措施: Hyperfractionated RT (Radiation)
Arm 2: Hyperfractionated RT + Carmustine
Hyperfractionated RT: 72.0 Gy/60 fractions/6 weeks/1.2 Gy BID + carmustine 80 mg/m2 IV on Days 1, 2, 3 of RT and then every 8 weeks for 6 cycles
干预措施: Carmustine (Drug)
结局指标
主要结局
Overall Survival
时间窗: From randomization to the date of death or last follow up, assessed up to 131 months.
Overall Survival
次要结局
未报告次要终点