A Randomized Controlled Trial of Early Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1-year rate of skeletal-related events (SREs)
研究概览
简要总结
This is a prospective, randomized, single-center clinical trial evaluating whether early prophylactic radiotherapy to high-risk asymptomatic or minimally symptomatic bone metastases reduces the 1-year rate of skeletal-related events (SREs) in patients with metastatic solid cancers. Patients will be randomized in a 1:1 ratio to receive either standard of care systemic therapy or observation, or prophylactic radiotherapy in addition to standard of care. The primary endpoint is the 1-year rate of SREs. Secondary endpoints include adverse events, quality of life, economic burden, pain-free survival, and overall survival.
详细描述
Bone metastases are a common complication in patients with metastatic solid cancers and are associated with significant morbidity, including skeletal-related events (SREs) such as pathological fractures, spinal cord compression, and severe pain requiring intervention. While palliative radiotherapy is an established treatment for symptomatic bone metastases, the role of prophylactic radiotherapy in asymptomatic or minimally symptomatic high-risk lesions remains insufficiently defined.
This prospective, randomized, single-center phase II clinical trial evaluates the effectiveness of early prophylactic radiotherapy in reducing the incidence of SREs. Eligible patients with metastatic solid cancers and up to five high-risk asymptomatic or minimally symptomatic bone metastases will be randomized in a 1:1 ratio into two groups. The control group will receive standard of care systemic therapy or observation according to tumor type and clinical guidelines. The intervention group will receive prophylactic external-beam radiotherapy (25 Gy in 5 fractions) to selected high-risk bone metastases in addition to standard of care.
Patients will be followed from baseline up to 12 months, with assessments conducted at predefined intervals. Study outcomes include the incidence of SREs, adverse events (graded according to CTCAE), patient-reported outcomes using validated questionnaires (EORTC QLQ-C30, EQ-5D-5L, BPI), economic burden, pain-free survival, and overall survival.
This study aims to determine whether early radiotherapy intervention can prevent skeletal complications, reduce healthcare burden, and improve patient outcomes in metastatic bone disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
This is an open-label study due to the nature of the intervention (radiotherapy), which does not allow blinding of participants or investigators.
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
- •Age ≥18 years
- •Histologically confirmed solid malignancy
- •Metastatic disease confirmed by imaging (CT, MRI, or PET-CT)
- •Presence of up to five high-risk bone metastases
- •High-risk bone metastases defined according to protocol criteria
- •Asymptomatic or minimally symptomatic bone metastases (not requiring opioid analgesics)
- •ECOG performance status 0-2
- •Ability to provide written informed consent
排除标准
- •Prior radiotherapy to the index bone metastases preventing safe treatment planning
- •Symptomatic bone metastases requiring immediate palliative radiotherapy
- •Evidence of spinal cord compression
- •Bone metastases causing significant pain requiring opioid analgesics
- •Oligometastatic disease suitable for radical treatment
- •Leptomeningeal disease
- •ECOG performance status ≥3
- •Life expectancy less than 3 months
- •Any condition that, in the investigator's opinion, would interfere with study participation or assessment
研究组 & 干预措施
Prophylactic Radiotherapy + Standard of Care
Participants receive prophylactic external-beam radiotherapy (25 Gy in 5 fractions) to up to five high-risk asymptomatic or minimally symptomatic bone metastases, in addition to standard of care systemic therapy or observation.
干预措施: Prophylactic External Beam Radiotherapy (Radiation)
Prophylactic Radiotherapy + Standard of Care
Participants receive prophylactic external-beam radiotherapy (25 Gy in 5 fractions) to up to five high-risk asymptomatic or minimally symptomatic bone metastases, in addition to standard of care systemic therapy or observation.
干预措施: Standard of Care (Other)
Standard of Care
Participants receive standard of care systemic therapy or observation according to tumor type and clinical guidelines, without prophylactic radiotherapy.
干预措施: Standard of Care (Other)
结局指标
主要结局
1-year rate of skeletal-related events (SREs)
时间窗: From randomization to 12 months after randomization
Number of participants experiencing at least one skeletal-related event (pathological fracture, spinal cord compression, need for radiation to bone, need for surgery to bone, or tumor-related hypercalcemia) within 12 months after randomization.
次要结局
- Incidence of adverse events(Up to 12 months after randomization)
- EORTC QLQ-C30 global health status score(Baseline, 3 months, 6 months, and 12 months after randomization)
- EQ-5D-5L index score(Baseline and follow-up visits up to 12 months after randomization)
- Brief Pain Inventory (BPI) pain intensity score(Baseline and follow-up visits up to 12 months after randomization)
- Pain-free survival(From randomization to 12 months after randomization)
- Overall survival(From randomization to 12 months after randomization)
- Healthcare resource utilization(From randomization to 12 months after randomization)