A Phase III Randomized Trial Of The Role Of Whole Brain Radiation Therapy In Addition To Radiosurgery In The Management Of Patients With One To Three Cerebral Metastases
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 74
- 主要终点
- Overall survival (OS)
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if radiosurgery is more effective with or without whole-brain radiation therapy in treating brain metastases.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiosurgery with or without whole-brain radiation therapy in treating patients who have brain metastases.
详细描述
OBJECTIVES:
- Compare the overall survival of patients with 1 to 3 cerebral metastases treated with radiosurgery with or without whole brain radiotherapy.
- Compare the time to CNS failure (brain) in patients treated with these regimens.
- Compare the quality of life, duration of functional independence, and long-term neurocognitive status in patients treated with these regimens.
- Compare the post-treatment toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and over vs under 60), extracranial disease (controlled for more than 3 months vs controlled for 3 months or less), and number of brain metastases (1 vs more than 1). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiosurgery.
- Arm II: Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks.
Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cerebral metastases meeting all of the following requirements:
- •1-3 de novo lesions
- •Metastases must be from a histologically confirmed extracerebral primary site, another metastatic site, or from the metastatic brain lesion(s)
- •Each lesion must be less than 3.0 cm by contrasted MRI of the brain
- •Lesions must not be within 5 mm of optic chiasm or within the brainstem
- •No primary germ cell tumor, small cell carcinoma, or lymphoma
- •No leptomeningeal metastases
- •Eligible for treatment with gamma knife or linear accelerator-based radiosurgery
- •Performance status - ECOG 0-2
- •Performance status - Zubrod 0-2
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •* Male patients must continue to use contraception for 3 months after the completion of radiotherapy
- •No pacemaker or other MRI-incompatible metal in body
- •No known allergy to gadolinium
- •Deemed to be at low risk for recurrence from any prior malignancies
- •At least 7 days since prior chemotherapy
- •Concurrent hormonal agents allowed
- •Concurrent steroids allowed
- •No prior cranial radiotherapy
- •No prior resection of cerebral metastasis
- •Concurrent anticonvulsants allowed provided therapeutic serum/plasma level maintained before study intervention
排除标准
- 未提供
结局指标
主要结局
Overall survival (OS)
时间窗: Up to 6 months
次要结局
- Time to CNS failure(Up to 4 years)
- Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire(From baseline to up to 3 months)
- Change in the duration of functional independence using the Barthel ADL Index score(From baseline to up to 4 years)