Cohort Study for Local Stereotactic Body Radiotherapy in Patients With Oligometastatic or Oligoprogressive Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The goal of this observational study is to evaluate the efficacy and safety of stereotactic body radiotherapy (SABR) in patients with oligometastatic or oligoprogressive cancer.
The main questions it aims to answer are:
- oncologic outcomes (progression-free survival, local failure rate),
- patient-reported outcomes,
- physician-assessed toxicity, and
- dynamics of circulating tumor DNA (ctDNA) for biomarker analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Performance status (ECOG PS) 0-2
- •Diagnosed with metastatic disease
- •Confirmed to have oligometastatic/oligoprogressive cancer on imaging performed within 4 weeks (up to 5 lesions)
排除标准
- •Patient with a history of prior radiotherapy to the site planned for SABR
- •Patients with concomitant brain metastases
结局指标
主要结局
Progression-free survival
时间窗: From start of SABR to the earliest of local failure, distant failure, death, or last follow-up. It will be measured at 1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.
Time from the start of stereotactic body radiotherapy (SABR) to the first documented event of local failure, distant failure, death from any cause, or last follow-up, whichever occurs first.
Physician assessed toxicity
时间窗: 1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.
Evaluated by treating physician based on CTCAE ver 5.0
Patient-reported outcome
时间窗: 1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.
It will be measured by PRO-CTCAE coreset 12.
Local failure
时间窗: 1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.
Local regrowth or progression at the site of SABR.
Dynamics of ctDNA
时间窗: It will be collected 1-week before SABR and 4-6 weeks after SABR.
ctDNA analysis
次要结局
未报告次要终点
研究者
Nalee Kim
Assistant professor
Samsung Medical Center