A Randomized Trial of Early, Upfront Palliative Radiation Therapy Versus Standard of Care for Patients With Highest Risk Asymptomatic or Minimally Symptomatic Bone Metastases
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 9
- 主要终点
- Number of Participants With Skeletal Related Events (SREs)
研究概览
简要总结
The purpose of the study is to compare the outcome of patients who receive standard treatment versus those who receive preventative radiation and then standard treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Histologically confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on imaging.
- •Has high risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risks metastases are defined as:
- •bulkiest sites of osseous disease ≥ 2cm,
- •disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints
- •disease in long bones with1/3-2/3 cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpus, phalanges)
- •disease in junctional spine (C7-T1, T12-L1, L5-S1) and/or disease with posterior element involvement.
- •ECOG performance status 0 -
- •Age ≥ 18 years.
- •Able to provide informed consent.
- •Patients at reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating.
排除标准
- •Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
- •Serious medical co-morbidities precluding radiotherapy.
- •Pregnant or lactating women.
- •Target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture.
- •Leptomeningeal disease.
- •Malignant pleural effusion.
- •Absolute neutrophil count (ANC) <1.0 K/mcL and platelet count <50 K/mcL at time of enrollment.
- •Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.
研究组 & 干预措施
Standard of care
Patients randomized to Arm 1 will undergo appropriate therapy as determined by their oncologist. These patients will either continue their current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to Arm 1, these patients may undergo palliative RT for progressive, painful lesions (a skeletal related event) at time of symptom development (not upfront palliative RT).
干预措施: Systemic Therapy (Drug)
Selective radiation to ≤5 highest risk bone metastases
Patients on Arm 2 of the study will undergo selective RT to ≤ 5 high risk bone metastases defined as 1. bulkiest sites of osseous disease ≥ 2cm, 2. disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints 3. disease in long bones with1/3-2/3 cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpus, phalanges) 4. disease in junctional spine (C7-T1, T12-L1, L5-S1) &/or disease with posterior element involvement.
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Number of Participants With Skeletal Related Events (SREs)
时间窗: 1 year
which will be defined as pathological fractures, spinal cord compression, or palliative radiotherapy and orthopedic surgery to bone.
次要结局
未报告次要终点