Impact of Prophylactic Bone Radiation Therapy on Morbidity and Mortality in Patients With Asymptomatic Bone Metastases and an Intermediate Risk of Bone Events.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Bone event
研究概览
简要总结
Radiation therapy is a common treatment for painful bone metastases, proving effective in 1 to 2/3 of cases after 1 to 10 sessions, with stereotactic body radiation therapy (SBRT) likely offering superior results.
Radiation therapy is also used to prevent bone events, although its use is not standardized; the decision to administer it is made by clinicians or through multidisciplinary team (MDT) discussions.
Recently, it has been shown that preventive radiation therapy can reduce the risk of skeletal-related events (SREs) in patients at high risk for bone events.
The objective is to compare active surveillance with preventive radiation therapy in patients at intermediate risk for bone 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, 18 years of age or older
- •Patients with solid cancer and bone metastases
- •Patients with bone lesions considered to be at intermediate risk for skeletal-related events (SINS score between 7 and 12, Mirels 8) or patients with lesions accompanied by Grade 1 epiduritis (Bilsky)
- •Enrolled in or covered by a social insurance program
- •Patients with an estimated life expectancy of more than 6 months
排除标准
- •Hematologic disease
- •Patients with a lesion at high risk for skeletal-related events (SINS score of 13 or higher, MIRELS score of 9 or higher, or a multidisciplinary team (MDT) recommendation that surgery is necessary)
- •Patients with pain secondary to bone lesions requiring radiation therapy
- •Contraindication to radiation therapy due to a history of radiation therapy at the same site or a condition contraindicating radiation therapy
- •Pregnant or breastfeeding women
- •Contraindication to MRI in cases of spinal lesions; contrast-enhanced CT scan
- •Patients unable to understand the study for any reason or to comply with the trial requirements (language, psychological, geographic issues, etc.)
- •Patients under legal guardianship or conservatorship
- •Patients classified as WHO 3 or 4
结局指标
主要结局
Bone event
时间窗: one year
rate of bone event in the two arms
次要结局
未报告次要终点