Role of Metastases Directed Radiotherapy in Addition to Standard of Care Systemic Treatment in the Management of Extracranial Oligometastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Overall Response rate
研究概览
简要总结
This is a phase III randomized study evaluating the benefit from adding metastases directed therapy and locoregional treatment of the primary in breast cancer patients diagnosed with de novo oligometastatic disease patients will be randomized to receive the standard of care (SOC) treatment vs. systemic treatment + Stereotactic Ablative Radiation Therapy. Responders will be randomized to either undergo loco-regional management of the primary tumor or not
详细描述
Objectives:
Primary objectives:
• Assessment of the outcome (progression free survival) of patients with extracranial oligometastatic breast cancer receiving standard of care systemic treatment compared to patients receiving ablative radiotherapy in addition to systemic treatment
Secondary objectives:
- Improving quality of life of patients with oligometastatic breast cancer (OMBC)
- Ensuring a safe toxicity profile among the patients receiving SBRT to the metastatic sites in addition to SOC treatment vs patients who receive SOC treatment alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18 to 70 years.
- •Pathological evidence of breast cancer, any grade, any T stage.
- •Radiological (at least) evidence of metastatic activity with maximum number of 5 extracranial lesions.
- •Performance status ≤ 2
- •No pre-existing conditions that may prohibit radiotherapy.
排除标准
- •.Pregnant and lactating women.
- •Prior radiotherapy to affected site(s) in less than a year.
- •Active Connective tissue diseases (e.g Rheumatoid Arthritis).
- •Progression to widespread metastatic disease
- •Cases with brain metastasis
结局指标
主要结局
Overall Response rate
时间窗: assessed using physical exam and PET CT after six months of systemic treatment
rate of patients responding to therapy
Progression Free Survival
时间窗: from the time of randomization till disease progression or death up-to 120 months
Time till disease progression
次要结局
未报告次要终点
研究者
Rimoun Ramsis Anis Boutrus
Assistant Professor, Radiation Oncology
National Cancer Institute, Egypt