Prognostic Factors Associated With Successful Omission of Whole Brain Radiotherapy in Patients With 4 or Less Cerebral Metastases Treated With Focal Radiation or Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells in a single high dose. Combining radiation therapy with surgery may be a more effective treatment for brain metastases.
PURPOSE: Clinical trial to study the effectiveness of radiation therapy with or without surgery in treating patients who have brain metastases.
详细描述
OBJECTIVES:
- Develop prognostic factors for patients with brain metastases treated by focal treatment without concurrent whole brain irradiation.
- Determine whether focal treatment without whole brain radiotherapy produces good long-term outcome in patients with four or less cerebral metastases.
- Assess survival, physical and cognitive functioning, and quality of life of patients treated on this protocol.
OUTLINE: Quality of life is assessed using the FACT-BR scale, physical function is assessed using the FIM scale, and cognition is assessed using two brief pencil and paper tests.
Patients receive focal therapy for cerebral metastases by any combination of (1) surgery plus fractionated stereotactic radiotherapy to surgical bed, or (2) single fraction stereotactic radiotherapy by linear accelerator with or without a radiation sensitizer.
Patients are followed at 2 and 10 weeks, then every 3 months for 18 months, then every 6 months for 3 years, then annually. Quality of life is assessed at each followup visit.
研究设计
- 研究类型
- Interventional
- 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
- •Biopsy, CT scan, or MRI proven cerebral metastases with known current or previous systemic malignancy OR
- •Biopsy proven cerebral metastases other than from small cell lung cancer or lymphoma
- •Refused whole brain radiation therapy OR
- •Received prior whole brain radiation therapy and ineligible for other relapse protocols
- •18 and over
- •Karnofsky 60-100%
- •Life expectancy:At least 3 months
- •Concurrent steroids allowed
排除标准
- •more than four cerebral metastases on MRI scan and suitable for focal treatment with surgery and/or stereotactic radiotherapy with a linear accelerator
- •more than 2 weeks since prior focal radiation
- •more than 2 weeks since prior focal surgery