NCT03212235Unknown2 期
Hypofractionated Radiation Therapy Plus Concomitant and Adjuvant Temozolomide for Glioblastoma
Instituto do Cancer do Estado de São Paulo2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2017年6月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
Notwithstanding major improvements in treatment modalities, the prognosis of patients with glioblastoma is poor. Hypofractionated radiation therapy as an alternative of the standard 6-week regimen could be an attractive approach as an effort to prevent tumor cell repopulation and reduction the total treatment period promoting patient comfort and convenience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients 18 to 70 years of age with newly diagnosed and histologically confirmed glioblastoma.
- •WHO performance status of 2 or less and adequate hematologic, renal, and hepatic function.
排除标准
- •Prior diagnosis of cancer, unless disease free for > 3 years
- •Previous history of radiotherapy in the head and neck region (except initial larynx tumor - T1, T2 / N0M0).
- •Specific severe, active co-morbidities
- •Tumor located in the brainstem
- •Presence of leptomeningeal carcinomatosis
- •Multicentric tumor
结局指标
主要结局
Overall survival
时间窗: 24 months
From date of the start of treatment to date of death due to any cause.
次要结局
- Progression-free survival(24 months)
研究者
Gustavo Nader Marta
Radiation Oncologist and Principal Investigator
Instituto do Cancer do Estado de São Paulo
研究点 (2)
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