Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Non Small Cell Lung Cancer: A Registry-based Phase II Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
A registry-based randomized screening phase II trial. A total of 68 patients with metastatic non small cell lung cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.
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
- Single (Outcomes Assessor)
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 years
- •Metastatic NSCLC enrolled in our CRCHUM Lung Cancer Registry and co-enrolled to the PERa registry
- •Ability to provide written informed consent
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- •Oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs. Progression at the primary tumor site should be counted within the total of 5 lesions. For patients with lymph node metastases, each node is counted as one site of metastasis.
- •Oligoprogression while on ICI or TKI (any line)
- •Patients with brain metastasis are allowed; brain metastasis are not counted in the maximum number of lesions and should be treated as per standard of care
- •All sites of disease can, in the opinion of the investigator, be safely treated and targetable with SABR (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.)
- •Patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible.
排除标准
- •Any lesion beyond 5 cm
- •Pregnancy or breastfeeding
- •Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy.
- •Presence of spinal cord compression Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel)
研究组 & 干预措施
Standard of care
Switch to subsequent systemic therapy line, best supportive care or continue current systemic line
干预措施: SABR (Radiation)
Experimental SABR arm
Definitive SABR to oligoprogressive lesions + continue current systemic therapy
干预措施: Standard of care (Other)
结局指标
主要结局
OS
时间窗: 5 years
OS defined as time from randomization to time of death from any cause.
PFS
时间窗: 5 years
PFS defined from randomization to disease progression at any site or death
次要结局
- Time to next systemic therapy(5 years)
- Quality of life 5-level EQ-5D (EQ-5D-5L)(5 years)
- Local control(5 years)
- Grade ≥ 3 toxicity(5 years)
- Quality of life Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)(5 years)