Randomized Phase III Study of Conventional Versus Hypofractionated Radiotherapy Combined With Temozolomide in Elderly Glioblastoma Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
In newly diagnosed glioblastoma patients aged 70 years or older who are suitable for concurrent temozolomide, the optimal dose of radiation therapy is controversial . The purpose of this study is to compare conventional radiotherapy of 60 Gy (6 weeks) versus hypofractionated radiotherapy of 40 Gy (3 weeks) in terms of overall survival as the primary endpoint along with progression-free survival, toxicity, quality of life, and prognostic biomarkers.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed glioblastoma according to the 2021 World Health Organization classification
- •interval of ≤4 weeks between pathological diagnosis and randomization
- •aged 70 years or older
- •gadolinium-enhanced MRI within 72 hours of surgery
- •known o6-methylguanine-DNA-methyltransferase promoter methylation status
- •Karnofsky performance score ≥60
- •stable or decreasing dose of steroid (if necessary)
- •no history of brain radiotherapy
- •no history of any systemic chemotherapy
- •adequate hematological, renal and hepatic functions for temozolomide
- •able to start radiotherapy within 3 weeks from randomization
排除标准
- •patients with spinal leptomeningeal carcinomatosis
- •history of cancer other than the followings:
- •carcinoma in situ of the cervix
- •completely excised non-melanoma skin cancer
- •cancers without any evidence of residual disease for 5 years or longer
- •patients with serious active infection or other serious underlying medical conditions
- •patients with psychological issues that cannot comply to the protocol
- •patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide
- •patients who are currently participating in other clinical trials
研究组 & 干预措施
Hypofractionated radiochemotherapy
Radiotherapy: 40.05 Gy in 15 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
干预措施: Hypofractionated radiotherapy (Radiation)
Hypofractionated radiochemotherapy
Radiotherapy: 40.05 Gy in 15 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
干预措施: Temozolomide (Drug)
Conventional radiochemotherapy
Radiotherapy: 60 Gy in 30 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
干预措施: Conventional radiotherapy (Radiation)
Conventional radiochemotherapy
Radiotherapy: 60 Gy in 30 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
干预措施: Temozolomide (Drug)
结局指标
主要结局
Overall survival
时间窗: follow-up until 2 years
from randomization
次要结局
- progression-free survival(follow-up until 2 years)
- patient-reported quality of life(follow-up until 2 years)
- treatment-related toxicity(follow-up until 2 years)
研究者
Chan Woo Wee, M.D., Ph.D
M.D, PhD
Severance Hospital