Radiotherapy to Optimize Event-free Survival Following Chemo-Immunotherapy and Surgery in Upper Stage III NSCLC With Evidence of Pathological Residual Disease (RESCUE): Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Disease-free Survival
研究概览
简要总结
This study investigates whether postoperative radiotherapy (PORT) improves outcomes for patients with stage III non-small cell lung cancer (NSCLC) who have residual disease after neoadjuvant chemo-immunotherapy and surgery. The primary objective is to compare event-free survival (EFS) between patients receiving PORT targeting involved lymph node regions and those without PORT. Secondary and tertiary endpoints include overall survival, locoregional and distant control, toxicity, and quality of life. The phase II randomized trial will enroll 118 patients, stratifying by adjuvant immunotherapy use, with follow-up extending up to 5 years. Statistical analysis aims to detect a 15% improvement in 2-year EFS, with a total study duration of 7 years.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be ≥ 18 years old
- •Ability to provide written informed consent
- •ECOG performance status 0-2
- •Histologically confirmed NSCLC
- •Absence of actionable driver mutation (EGFR/ALK/ROS)
- •Complete preoperative imaging staging, including: FDG-PET and brain imaging to exclude distant metastases will be mandatory.
- •Baseline clinical or post-operative pathological stage III including specifically stage T1-4N2-3
- •Completion of 2-4 cycles of neoadjuvant chemo-IO, regardless of the specific immunotherapy and chemotherapy used.
- •Status post-complete (R0) surgical resection with mediastinal lymph node dissection.
- •Residual nodal disease on final pathology specimen (i.e. absence of pathological complete response).
- •Postoperative lung function examination: FEV1 > 1 L (or greater than 35% expected value)
排除标准
- •Pregnant individuals
- •Previous chest radiotherapy
- •>24 weeks after thoracic surgery
- •History of other non-cutaneous neoplasms within the last 24 months
- •Active grade ≥ 2 pneumonitis.
- •Presence of interstitial lung disease
- •Recurrence or metastasis occurred
- •Medical conditions that hinders the safe administration of radiotherapy or follow-up.
研究组 & 干预措施
Post-operative radiotherapy
Mediastinal PORT (40 Gy in 15 fractions) within 24 weeks from thoracic surgery
干预措施: Post-operative radiotherapy (Radiation)
No post-operative radiotherapy
No post-operative radiotherapy (PORT)
结局指标
主要结局
Disease-free Survival
时间窗: Defined as the time from random assignment to loco-regional or distant recurrence, or death from any cause, assessed up to 60 months.
次要结局
- Overall Survival(Time from random assignment to death from any cause, assessed up to 60 months.)
- Grade 3 Toxicity(Classified as early (within the first 3 months) or late (after 3 months), assessed up to 60 months.)
- Locoregional control(Time from random assignment to locoregional recurrence, proven radiologically and/or pathologically, assessed up to 60 months.)
- Distant metastasis free survival(Time from random assignment to distant recurrence, proven radiologically and/or pathologically, or death from any cause, assessed up to 60 months.)
研究者
Houda Bahig
Radiation Oncologist
Centre hospitalier de l'Université de Montréal (CHUM)