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Liver metastases often occur in close proximity to radiosensitive organs at risk (OARs). This limits the possibility to apply sufficiently high doses needed for optimal local control. Online MR-guided radiotherapy (oMRgRT) is expected to hold potential to improve hepatic SBRT by offering superior soft-tissue contrast for enhanced target identification as well as the benefit of gating and daily real-time adaptive treatment. The MAESTRO trial therefore aims to assess the potential advantages of adaptive, gated MR-guided SBRT compared to conventional SBRT at a standard linac using an ITV (internal target volume) approach.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This trial is conducted as a prospective, randomized, three-armed phase II study in 82 patients with hepatic metastases (solid malignant tumor, 1\u20133 hepatic metastases confirmed by magnetic resonance imaging (MRI), maximum diameter of each metastasis\u2009\u2264\u20095\u00a0cm (in case of 3 metastases: sum of diameters\u2009\u2264\u200912\u00a0cm), age\u2009\u2265\u200918\u00a0years, Karnofsky Performance Score\u2009\u2265\u200960%). If a biologically effective dose (BED)\u2009\u2265\u2009100\u00a0Gy (\u03b1\/\u03b2\u2009=\u200910\u00a0Gy) is feasible based on ITV-based planning, patients will be randomized to either MRgRT or ITV-based SBRT. If a lesion cannot be treated with a BED\u2009\u2265\u2009100\u00a0Gy, the patient will be treated with MRgRT at the highest possible dose. Primary endpoint is the non-inferiority of MRgRT at the MRIdian Linac\u00ae system compared to ITV-based SBRT regarding hepatobiliary and gastrointestinal toxicity CTCAE III or higher. Secondary outcomes investigated are local, locoregional (intrahepatic) and distant tumor control, progression-free survival, overall survival, possible increase of BED using MRgRT if the BED is limited with ITV-based SBRT, treatment-related toxicity, quality of life, dosimetric parameters of radiotherapy plans as well as morphological and functional changes in MRI. Potential prognostic biomarkers will also be evaluated.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>MRgRT is known to be both highly cost- and labor-intensive. The MAESTRO trial aims to provide randomized, higher-level evidence for the dosimetric and possible consecutive clinical benefit of MR-guided, on-table adaptive and gated SBRT for dose escalation in critically located hepatic metastases adjacent to radiosensitive OARs.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>\n                           <jats:italic>Trial registration<\/jats:italic>\n                        <\/jats:title>\n                <jats:p>The study has been prospectively registered on August 30th, 2021: Clinicaltrials.gov, \u201cMagnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases (MAESTRO)\u201d, NCT05027711.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13014-022-02033-2","type":"journal-article","created":{"date-parts":[[2022,3,28]],"date-time":"2022-03-28T11:02:44Z","timestamp":1648465364000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["MR-guided adaptive versus ITV-based stereotactic body radiotherapy for hepatic metastases (MAESTRO): a randomized controlled phase II trial"],"prefix":"10.1186","volume":"17","author":[{"given":"P.","family":"Hoegen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K. 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In the clinical study, no ionizing radiation in humans for the purpose of medical research will be used, since all treatments within this protocol are clinically indicated and performed within the medical responsibility of the participating centers and only clinically established therapies and diagnostics are used. The study was submitted to the DEGRO expert committee for advice and the committee classified the protocol as medical science (\u201cHeilkunde\u201d). An application to the Federal Office for Radiation Protection (Bundesamt f\u00fcr Strahlenschutz, BfS) is therefore not required. This study complies with the Helsinki Declaration and its recent German version, the Medical Association code of conduct, the principles of Good Clinical Practice (GCP) and the Federal Data Protection Act. The trial will be carried out in keeping with local legal and regulatory requirements. Each patient must provide written informed consent for participation in the study and for publication before enrollment.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"J. H.-R. and S. K. received speaker fees and travel reimbursement from ViewRay Inc. J. H.-R. received travel reimbursement from IntraOP Medical and Elekta Instrument AB and a grant from IntraOP Medical outside the submitted work. M. N. received speaker fees and honoraria from Brainlab AG and Novocure. J.D. received grants from CRI\u2014The Clinical Research Institute GmbH, Accuray International S\u00e0rl, View Ray Inc., Accuray Incorporated, RaySearch Laboratories AB, Vision RT limited, Astellas Pharma GmbH, Astra Zeneca GmbH, Solution Akademie GmbH, Ergomed PLC Surrey Research Park, Siemens Healthcare GmbH, Quintiles GmbH, Pharmaceutecal Research Associates GmbH, Boehringer Ingelheim Pharma GmbH Co, PTW-Freiburg Dr. Pychlau GmbH, Nanobiotix A.A., Merck Serono GmbH and IntraOP Medical outside the submitted work.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"59"}}