Systemic Therapy With or Without Local Radiotherapy for Extracranial Oligometastatic Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Progression-free Survival
研究概览
简要总结
More and more evidence suggests that local radiotherapy can improve the outcomes for patients with oligometastatic disease. The purpose of this study is to assess the impact of radiotherapy, compared with standard systemic therapy alone, on survival, local control and toxicities in patients with extracranial oligometastatic breast cancer. Eligible patients are randomized in a 1:2 ratio between the control arm (standard systemic therapy), and the WLRT arm (standard systemic therapy + radiotherapy). Randomization will be stratified by three factors: visceral metastasis (yes vs.no), number of metastases(≤2 vs. >2), hormone receptor(positive vs. negative). SBRT technique is preferred. During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-70 years old
- •ECOG performance status 0-
- •Newly-diagnosed or metachronous extracranial oligometastatic diseases confirmed by pathology or imaging, with or without locoregional disease (biopsy of metastasis is preferred).
- •Total number of locoregional and metastatic lesions of 1-5 , the maximum diameter of lesions ≤5 cm and at least one lesion could be evaluated by RECIST1.
- •Have received or plan to receive systemic therapy.
- •All lesions could be safely treated by radiotherapy.
- •Life expectancy > 6 months.
- •Have adequate organ function.
排除标准
- •Have metastases in the central nervous system.
- •have indications for palliative radiotherapy to reduce symptoms, such as pain, bleeding, obstruction, and pending fractures caused by the tumor.
- •Have moderate/severe liver dysfunction (Child Pugh B or C) from liver metastases, .
- •Malignant pleural effusion
- •Unable to tolerate radiotherapy due to serious comorbidity
- •Have received prior radiotherapy for target area
- •Pregnant or lactating women
研究组 & 干预措施
study arm
radiotherapy + standard of care
干预措施: standard of care (Drug)
control arm
standard of care
干预措施: standard of care (Drug)
study arm
radiotherapy + standard of care
干预措施: radiotherapy + standard of care (Radiation)
结局指标
主要结局
Progression-free Survival
时间窗: 2 years
Time from randomization to disease progression at any site or death.
次要结局
- Overall Survival(2 years)
- Local control rate(2 years)
- Incidence of toxicities(2 years)
- Quality of Life measured by the Functional Assessment of Cancer Therapy- General (FACT-G)(2 years)
- Translational exploration(2 years)
- Proportion of acceptable SBRT completion(2 years)
研究者
Shu lian Wang
Clinical professor
Chinese Academy of Medical Sciences