Division of Radiation Oncology, IEO European Institute of Oncology IRCCS, Milan, 20141, Italy.
Department of Oncology and Hemato-Oncology, University of Milan, Milan, 20122, Italy.
BMC Cancer. 2023 Dec 15;23(1):1236. doi: 10.1186/s12885-023-11701-9.
Currently, main treatment strategies for early-stage non-small cell lung cancer (ES-NSCLC) disease are surgery or stereotactic body radiation therapy (SBRT), with successful local control rates for both approaches. However, regional and distant failure remain critical in SBRT, and it is paramount to identify predictive factors of response to identify high-risk patients who may benefit from more aggressive approaches. The main endpoint of the MONDRIAN trial is to identify multi-omic biomarkers of SBRT response integrating information from the individual fields of radiomics, genomics and proteomics.
MONDRIAN is a prospective observational explorative cohort clinical study, with a data-driven, bottom-up approach. It is expected to enroll 100 ES-NSCLC SBRT candidates treated at an Italian tertiary cancer center with well-recognized expertise in SBRT and thoracic surgery. To identify predictors specific to SBRT, MONDRIAN will include data from 200 patients treated with surgery, in a 1:2 ratio, with comparable clinical characteristics. The project will have an overall expected duration of 60 months, and will be structured into five main tasks: (i) Clinical Study; (ii) Imaging/ Radiomic Study, (iii) Gene Expression Study, (iv) Proteomic Study, (v) Integrative Model Building.
Thanks to its multi-disciplinary nature, MONDRIAN is expected to provide the opportunity to characterize ES-NSCLC from a multi-omic perspective, with a Radiation Oncology-oriented focus. Other than contributing to a mechanistic understanding of the disease, the study will assist the identification of high-risk patients in a largely unexplored clinical setting. Ultimately, this would orient further clinical research efforts on the combination of SBRT and systemic treatments, such as immunotherapy, with the perspective of improving oncological outcomes in this subset of patients.
The study was prospectively registered at clinicaltrials.gov (NCT05974475).
目前，早期非小细胞肺癌（ES-NSCLC）的主要治疗策略是手术或立体定向体部放射治疗（SBRT），这两种方法的局部控制率都很高。然而，SBRT 仍存在区域和远处失败的问题，因此识别对 SBRT 反应的预测因素至关重要，以便确定可能受益于更积极治疗方法的高危患者。MONDRIAN 试验的主要终点是确定 SBRT 反应的多组学生物标志物，整合放射组学、基因组学和蛋白质组学等各个领域的信息。
MONDRIAN 是一项前瞻性观察性探索性队列临床研究，采用数据驱动、自下而上的方法。预计将在一家意大利三级癌症中心招募 100 名接受 SBRT 治疗的 ES-NSCLC SBRT 候选患者，该中心在 SBRT 和胸部手术方面具有公认的专业知识。为了确定特定于 SBRT 的预测因素，MONDRIAN 将纳入 200 名接受手术治疗的患者的数据，比例为 1:2，具有可比的临床特征。该项目预计总持续时间为 60 个月，将分为五个主要任务：（i）临床研究；（ii）成像/放射组学研究；（iii）基因表达研究；（iv）蛋白质组学研究；（v）综合模型构建。
由于其多学科性质，MONDRIAN 有望提供从多组学角度对 ES-NSCLC 进行特征描述的机会，重点是放射肿瘤学。除了有助于对疾病的机制理解外，该研究还将有助于在一个尚未充分探索的临床环境中识别高危患者。最终，这将指导进一步的临床研究努力，将 SBRT 与免疫治疗等全身治疗相结合，以期改善这部分患者的肿瘤学结果。
该研究前瞻性地在 clinicaltrials.gov 上注册（NCT05974475）。
