NCT00002899终止3 期
Phase III Trial on Convergent Beam Irradiation of Cerebral Metastases
European Organisation for Research and Treatment of Cancer - EORTC66 个研究点 分布在 13 个国家目标入组 340 人开始时间: 1996年11月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 340
- 试验地点
- 66
- 主要终点
- Survival with a WHO performance status 0-2 as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Adjuvant radiation therapy may kill any remaining tumor cells following surgery or radiosurgery for brain metastases.
PURPOSE: This randomized phase III trial is studying surgery or radiosurgery alone to see how well it works compared to surgery or radiosurgery and whole-brain radiation therapy in treating brain metastases in patients with solid tumors.
详细描述
OBJECTIVES:
Primary
- Investigate the efficacy and toxicity of adjuvant whole brain radiotherapy after prior surgical resection or radiosurgery of 1 to 3 brain metastases from solid tumor in patients with good performance status and controlled systemic cancer.
Secondary
- Determine overall survival and progression-free survival of patients treated on this protocol.
- Determine time to neurologic progression in patients treated on this protocol.
- Determine quality of life of patients treated on this protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Survival with a WHO performance status 0-2 as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death
次要结局
- Overall survival as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death
- Progression-free survival as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death
- Time to neurological progression as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death
- Acute toxicity as measured by EORTC and RTOG scale 8 weeks after completion of study treatment, and then every 3 months until death
- Late toxicity as measured by Subjective, Objective, Management and Analytic/Late Effects on Normal Tissues (SOMA/LENT) scale 8 weeks after completion of study treatment, and then every 3 months until death
- Quality of life as measured by QLQ-C30 and BN-25 8 weeks after completion of study treatment, and then every 3 months until death
研究者
研究点 (66)
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