A Prospective, Single-Arm Phase II Clinical Trial of Standard Systemic Therapy Combined With Spatial Fractionated Radiotherapy (SFRT) for Oligoprogressive Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The goal of this clinical trial is to learn if spatially fractionated radiotherapy (SFRT) combined with standard systemic therapy can treat oligoprogressive non-small cell lung cancer (NSCLC) in patients who have progressed after at least one line of systemic therapy. The main question it aims to answer is:
- Can the combination of SFRT and standard systemic therapy improve progression-free survival (PFS) compared to standard systemic therapy alone?
Participants will:
- Undergo SFRT treatment for oligoprogressive lesions, with specific dose fractionation determined by the radiation oncologist based on clinical parameters.
- Continue their standard systemic therapy, which may include chemotherapy, targeted therapy, or immunotherapy, as adjusted by their treating physician.
- Have regular follow-up assessments, including imaging studies to evaluate treatment response and monitor for disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SFRT plus systemic therapy
干预措施: Spatially Fractionated Radiotherapy (SFRT)+Stereotactic Body Radiation Therapy (SBRT) (Radiation)
SFRT plus systemic therapy
干预措施: The systemic therapy (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From date of first study treatment to documented progression or death, assessed at 6 weeks, 12 weeks, 24 weeks, 48 weeks, and 72 weeks.
PFS will be determined based on radiological assessments using CT or MRI scans, according to the RECIST v1.1 criteria. Disease progression will be defined as an increase of at least 20% in the size of target lesions or the appearance of new lesions.
次要结局
- Objective Response Rate (ORR) of Irradiated Lesions(1 month after the completion of SFRT treatment and then every 3 months thereafter)
- Treatment-Related Adverse Events (TRAEs)(throughout the treatment period and for a predefined follow-up period, typically up to 12 months after treatment completion)
- Overall Survival (OS)(From date of first study treatment to death from any cause, assessed at 24 weeks, 48 weeks, and 72 weeks.)