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. 2023 Dec 15;23(1):1236.
doi: 10.1186/s12885-023-11701-9.

Multi-omics integrative modelling for stereotactic body radiotherapy in early-stage non-small cell lung cancer: clinical trial protocol of the MONDRIAN study

Stefania Volpe  1   2 , Mattia Zaffaroni  3 , Gaia Piperno  4 , Maria Giulia Vincini  4 , Maria Alessia Zerella  4 , Federico Mastroleo  4   5 , Federica Cattani  6 , Cristiana Iuliana Fodor  4 , Federica Bellerba  7 , Tiziana Bonaldi  8   7 , Giuseppina Bonizzi  9 , Francesco Ceci  8   10 , Marta Cremonesi  11 , Nicola Fusco  8   12 , Sara Gandini  7 , Cristina Garibaldi  11 , Davide La Torre  8   13 , Roberta Noberini  7 , Giuseppe Petralia  8   14 , Lorenzo Spaggiari  8   15 , Konstantinos Venetis  11 , Roberto Orecchia  16 , Monica Casiraghi #  8   15 , Barbara Alicja Jereczek-Fossa #  4   8
Affiliations

Multi-omics integrative modelling for stereotactic body radiotherapy in early-stage non-small cell lung cancer: clinical trial protocol of the MONDRIAN study

Stefania Volpe et al. BMC Cancer. .

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: The study was prospectively registered at clinicaltrials.gov (NCT05974475).

Keywords: Clinical trial; ES-NSCLC; Genomics; Integrative model building; NGS; NSCLC; Proteomics; Radiomics; SBRT.

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Conflict of interest statement

Division of Radiotherapy IEO received research funding from AIRC (Italian Association for Cancer Research) and Fondazione IEO-CCM (Istituto Europeo di Oncologia-Centro Cardiologico Monzino) (all outside the current project). BAJF received speakers fee from Roche, Bayer, Janssen, Carl Zeiss, Ipsen, Accuray, Astellas, Elekta, IBA, Astra Zeneca (all outside the current project). MGV was supported by a research fellowship from AIRC entitled “Radioablation ± hormonotherapy for prostate cancer oligorecurrences (RADIOSA trial): potential of imaging and biology”, registered at ClinicalTrials.gov NCT03940235, approved by the Ethics Committee of IRCCS Istituto Europeo di Oncologia and Centro Cardiologico Monzino (IEO-997). IEO, the European Institute of Oncology IRCCS, was partially supported by by institutional grants from Accuray Inc. and IBA (Ion Beam Applications, Louvain-la-Neuve, Belgium). The sponsors did not play any role in the study design, collection, analysis and interpretation of data, nor in the writing of the manuscript, nor in the decision to submit the manuscript for publication. The remaining authors declare no conflict of interest that are relevant to the content of this article.

Figures

Fig. 1
Fig. 1
Schematic representation of Task 1. Abbreviations: [18 F]-FDG-PET/CT: [18 F]Fluorodeoxyglucose positron emission tomography, ADL: Activities of Daily Living, C.E. CT: contrast-enhanced computed tomography, IADL: Instrumental Activities of Daily Living, MDASI: MD Anderson Symptom Inventory, SBRT: Stereotactic Body Radiotherapy
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