STereotactic Ablative RadioTherapy in NEWly Synchronous and mEtachRonous (Oligo-persistence, Oligo-induced, Oligo-progression) Oncogene and Non Oncogene Addicted OLIGO-metastatic Non-small Cell Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- new systemic therapy-free survival
研究概览
简要总结
This is a prospective, non-randomized, single arm, single institution phase II trial to evaluate the safety and effectiveness of stereotactic ablative radiotherapy (SABR) in oncogene addicted and non-oncogene addicted synchronous and/or metachronous oligo-metastatic (oligoM) non-small cell lung cancer (NSCLC) patients.
详细描述
Targeted Therapies and Immunotherapy have fundamentally changed the treatment of metastatic non-small cell lung cancer (NSCLC).
There is an increasing interest in the use of stereotactic ablative radiotherapy (SABR) for oligo-metastatic (oligo-M) NSCLC patients. It is postulated that definitive treatment of the primary as well as regional node/s and oligo-M in these patients may improve their overall survival (OS). Oligo-M is considered an intermediate state between local and poly-metastatic disease and is commonly defined as 1-5 metastatic lesions, in keeping with the recent European Society of Radiotherapy and Oncology (ESTRO) and American Society for Radiation Oncology (ASTRO) consensus.
If discovered within 4-6months of diagnosis, they are termed synchronous oligo-M. Alternatively, should oligo-M develop following definitive treatment of the primary tumour, this is termed metachronous oligo-M.
Multiple clinical trials have demonstrated prolonged survival following SABR treatment to all sites of oligo-M, particularly in NSCLC.
Targeted therapies (TT) and Immunotherapy (IT) have transformed the landscape of NSCLC treatment by improving OS in metastatic setting. However, most SABR trials for oligo-M patients were conducted in the pre-TT and pre-IT era. How SABR and TT or IT should be integrated in the treatment of oligo-M NSCLC therefore remains an active area of investigation.
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
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- •histologically confirmed NSCLC
- •synchronous oligo-M NSCLC as determined by Positron emission tomography- computed tomography (PET/CT) and brain MRI (AJCC 8th edition)
- •metachronous oligo-M NSCLC (oligo-persistence, oligo-progressive, oligo-induced) as determined by PET/CT and brain magnetic resonance imaging (MRI) (AJCC 8th edition)
- •patients with at least one target to be treated by SABR at the body
- •patients with brain metastases synchronous to the body will be enrolled only if amenable to radiosurgery (the number of brain metastases does not enter into the count of the number of oligo-M)
- •patients with a previous history of brain metastases will be enrolled only if the previously treated brain metastases are in control
排除标准
- •Ability to understand and the willingness to sign an institutional review board (IRB)- approved informed consent document (either directly or via a legally authorized representative)
- •Inability to safely treat target lesions
- •Pregnant women are excluded from this study because radiation therapy has known potential for teratogenic or abortifacient effects.
结局指标
主要结局
new systemic therapy-free survival
时间窗: 6 months; 1 year, 2 years, 3 years and 5 years
time that the patient maintains the same therapy without the need to change it
systemic therapy-free survival
时间窗: 6 months; 1 year, 2 years, 3 years and 5 years
time in which the patient does not need to start systemic therapy (for patients without active systemic therapy)
proportion of patients experiencing grade 3 or higher toxicities
时间窗: 6 months; 1 year, 2 years, 3 years and 5 years
SABR will be considered safe if no grade (G) or higher toxicities appears. Toxicity will be evaluated according CTCAE scale
次要结局
- progression free survival(6 months; 1 year, 2 years, 3 years and 5 years)
- time to new oligo-metastatic evidence(6 months; 1 year, 2 years, 3 years and 5 years)
- time to time to poly-metastatic progression not amenable by SABR(6 months; 1 year, 2 years, 3 years and 5 years)
- overall survival(6 months; 1 year, 2 years, 3 years and 5 years)
- local control(6 months; 1 year, 2 years, 3 years and 5 years)
研究者
Fabio Arcidiacono, MD
Principal Investigator
Radiotherapy Oncology Centre "Santa Maria" Hospital