Randomized Phase III Trial of Postoperative Whole Brain Radiation Therapy Compared With Salvage Stereotactic Radiosurgery in Patients With One to Four Brain Metastasis: Japan Clinical Oncology Group Study (JCOG 0504)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 42
- 主要终点
- overall survival
研究概览
简要总结
The aim of this study is to evaluate non-inferiority of salvage stereotactic radiosurgery (SRS) in the patients who received surgical resection for brain metastases in comparison with postoperative whole brain radiation therapy (WBRT).
详细描述
A randomized phase III study is started in Japan to compare postoperative whole brain radiation therapy with salvage stereotactic radiosurgery in patient with one to four brain metastases from lung, breast, and colorectal cancer.
Total of 270 patients will be accrued for this study from 21 institutions within three years. The primary endpoint is overall survival. The secondary endpoints are proportion of performance status (PS) preservation, proportion of mini-mental status examination (MMSE) preservation, and adverse events.
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •one to four brain metastases with a maximum diameter of 3 cm or more for the largest lesion and additional lesions not exceeding 3 cm in diameter
- •all brain metastases localized within cerebrum or cerebellum
- •before surgical resection for brain metastasis, PS is 0-2, or 3 by cerebral nerve compression neurological deficits
- •surgical resection for the largest brain metastases has achieved
- •after surgical resection, four or fewer (0-4) residual lesions with maximum diameter under 3 cm
- •histologically proven non-small cell carcinoma, breast cancer or colorectal cancer
- •primary lesion and the other metastases (i.e. lung, liver, bone metastases except for brain) is consider to be controlled
- •an age of 20-79 years
- •no prior surgery or irradiation for brain
- •adequate organ function
- •written informed consent(If signing in consent form is difficult for the patient due to paralysis, signing by the family in place of the patient is permitted)
排除标准
- •synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or mucosal cancer
- •pregnant or breast-feeding women
- •severe mental disease
- •allergic to gadolinium contained contrast agents
结局指标
主要结局
overall survival
时间窗: During the study conduct
次要结局
- adverse events(During the study conduct)
- proportion of mini-mental status examination (MMSE) preservation(During the study conduct)
- proportion of performance status (PS) preservation(During the study conduct)
研究者
Haruhiko Fukuda
JCOG Data Center
Japan Clinical Oncology Group