NCT00283543Unknown2 期
A Phase II Study of Radiation With Concomitant and Then Sequential Temozolomide in Patients With Newly Diagnosed Supratentorial Malignant Glioma Who Have Undergone Surgery With Gliadel Wafer Insertion
Kentuckiana Cancer Institute2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2002年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- To determine the safety and efficacy of Gliadel 3.85% wafers
研究概览
简要总结
To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide
详细描述
A phase II study of radiation with concomitant and then sequential Temozolomide in patients with newly diagnosed supratentorial malignant glioma who have undergone surgery with Gliadel wafer insertion. To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and limited field radiation therapy with concomitant Temozolomide followed by Temozolomide alone in patients undergoing initial surgery for newly diagnosed unifocal moderate to high grade glioma.
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
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MRI showing unilateral supratentorial cerebral tumor
- •surgical tx within 4 weeks of baseline MRI
- •KPS 60% or higher
- •moderate to high grade malignant glioma
排除标准
- •prior cytoreductive surgery for moderate or high grade glioma
- •prior CNS radiotherapy
- •prior chemo for this glioma
- •more than one focus of tumor or tumor crossing the midline per MRI
- •life expectancy less than 12 months
- •sensitivity to temozolomide, nitrosoureas, or Gliadel wafer
结局指标
主要结局
To determine the safety and efficacy of Gliadel 3.85% wafers
次要结局
未报告次要终点
研究者
研究点 (2)
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