Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Non-Small-Cell Lung Cancer on Tyrosine Kinase Inhibitor
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 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
This is an open-label, prospective single arm Phase II trial that investigates the role of ablative stereotactic body radiation therapy (SBRT) in oncogene driven metastatic non-small cell lung cancer (mNSCLC) patients with oligoprogressive disease (OPD) on targeted therapy (TKI) followed by circulating tumor DNA (ctDNA) analysis for tailoring targeted therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Age 18 or older.
- •Able to do most daily activities (ECOG 0-2).
- •Able and willing to sign an informed consent form to join the study.
- •Metastatic disease detected on imaging and histologically confirmed NSCLC on first-line TKI therapy
- •Willing to give a blood sample for ctDNA analysis.
- •No upper limit to the number of total metastatic sites, but a maximum of five progressive metastatic sites, inclusive of primary disease and metastatic lesions, all of which must be extracranial
- •Prior radiation therapy near progressive lesions is allowed if applicable.
- •All sites of oligoprogression that can be safely treated with SBRT or hypofractionated ablative radiotherapy
- •Oligoprogressive disease is evaluated independently for each lesion using specific criteria.
- •Stable brain metastases allowed if asymptomatic and do not require corticosteroids.
- •Oligoprogressive lesions previously treated with external beam radiation are eligible as long they are clinically asymptomatic, and re-treatment is possible according to the investigator. Prior conventional, non-stereotactic radiotherapy for palliative -purposes is allowed, and if the palliated lesion subsequently progressed but remains asymptomatic and does not require immediate radiotherapy, the lesion can still be counted toward one of the five oligoprogressive lesions
- •Participant is able (i.e. sufficiently fluent or with the assistance of a translator) and willing to complete the quality of life and/or health utility questionnaires in English
- •Accessible for treatment and follow-up.
排除标准
- •More than 5 extracranial sites of progressive disease.
- •Leptomeningeal disease.
- •Serious health issues that prevent radiotherapy, like ataxia-telangiectasia or scleroderma.
- •Prior radiation therapy near the progressive lesion that would prevent treatment with SBRT due to exceeding limits of healthy tissue tolerance.
- •Any other condition that the investigator believes makes participation in the study inappropriate.
研究组 & 干预措施
Decreasing or undetectable ctDNA levels after SBRT/high-dose radiotherapy
This group continues the same first-line standard of care or targeted systemic therapy after completion of SBRT.
干预措施: Radiotherapy (Radiation)
Persistent or increasing ctDNA levels after SBRT/high-dose radiotherapy
This group of patients will be switched to a different targeted therapy (second line) or standard of care systemic therapy after completion of SBRT.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Progression-free-survival
时间窗: 1 year
Progression-free-survival 1 (PFS1) will be determined from the first day of SBRT to oligoprogressive sites to the day of diagnosis of radiological progression in the subsequent imaging (irrespective of change in systemic therapy in group B, essentially second-line) or death
次要结局
- Subsequent progression-free-survival(1 year)
- Acute and Late Toxicities(1 year)
- Reported Adverse Events(1 year)
- Quality of Life Outcome(1 year)