MR-guided adaptive versus ITV-based stereotactic body radiotherapy for hepatic metastases (MAESTRO): a randomized controlled phase II trial
Abstract Background Stereotactic body radiotherapy (SBRT) is an established local treatment method for patients with hepatic oligometastasis or oligoprogression. Liver metastases often occur in close proximity to radiosensitive organs at risk (OARs). This limits the possibility to apply sufficiently...
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| Format: | Article |
| Language: | English |
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BMC
2022-03-01
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| Series: | Radiation Oncology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13014-022-02033-2 |
| _version_ | 1811260365912145920 |
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| author | P. Hoegen K. S. Zhang E. Tonndorf-Martini F. Weykamp S. Regnery P. Naumann K. Lang J. Ristau S. A. Körber C. Dreher C. Buchele C. Rippke C. K. Renkamp K. M. Paul L. König C. Büsch J. Krisam O. Sedlaczek H.-P. Schlemmer M. Niyazi S. Corradini J. Debus S. Klüter J. Hörner-Rieber |
| author_facet | P. Hoegen K. S. Zhang E. Tonndorf-Martini F. Weykamp S. Regnery P. Naumann K. Lang J. Ristau S. A. Körber C. Dreher C. Buchele C. Rippke C. K. Renkamp K. M. Paul L. König C. Büsch J. Krisam O. Sedlaczek H.-P. Schlemmer M. Niyazi S. Corradini J. Debus S. Klüter J. Hörner-Rieber |
| author_sort | P. Hoegen |
| collection | DOAJ |
| description | Abstract Background Stereotactic body radiotherapy (SBRT) is an established local treatment method for patients with hepatic oligometastasis or oligoprogression. 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. Methods This trial is conducted as a prospective, randomized, three-armed phase II study in 82 patients with hepatic metastases (solid malignant tumor, 1–3 hepatic metastases confirmed by magnetic resonance imaging (MRI), maximum diameter of each metastasis ≤ 5 cm (in case of 3 metastases: sum of diameters ≤ 12 cm), age ≥ 18 years, Karnofsky Performance Score ≥ 60%). If a biologically effective dose (BED) ≥ 100 Gy (α/β = 10 Gy) 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 ≥ 100 Gy, the patient will be treated with MRgRT at the highest possible dose. Primary endpoint is the non-inferiority of MRgRT at the MRIdian Linac® 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. Discussion 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. Trial registration The study has been prospectively registered on August 30th, 2021: Clinicaltrials.gov, “Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases (MAESTRO)”, NCT05027711. |
| first_indexed | 2024-04-12T18:45:23Z |
| format | Article |
| id | doaj.art-851d0ade4fec42de87fbe7a81461f681 |
| institution | Directory Open Access Journal |
| issn | 1748-717X |
| language | English |
| last_indexed | 2024-04-12T18:45:23Z |
| publishDate | 2022-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Radiation Oncology |
| spelling | doaj.art-851d0ade4fec42de87fbe7a81461f6812022-12-22T03:20:37ZengBMCRadiation Oncology1748-717X2022-03-0117111210.1186/s13014-022-02033-2MR-guided adaptive versus ITV-based stereotactic body radiotherapy for hepatic metastases (MAESTRO): a randomized controlled phase II trialP. Hoegen0K. S. Zhang1E. Tonndorf-Martini2F. Weykamp3S. Regnery4P. Naumann5K. Lang6J. Ristau7S. A. Körber8C. Dreher9C. Buchele10C. Rippke11C. K. Renkamp12K. M. Paul13L. König14C. Büsch15J. Krisam16O. Sedlaczek17H.-P. Schlemmer18M. Niyazi19S. Corradini20J. Debus21S. Klüter22J. Hörner-Rieber23Department of Radiation Oncology, Heidelberg University HospitalDivision of Radiology, German Cancer Research Center (DKFZ)Department of Radiation Oncology, Heidelberg University HospitalDepartment of Radiation Oncology, Heidelberg University HospitalDepartment of Radiation Oncology, Heidelberg University HospitalDepartment of Radiation Oncology, Heidelberg University HospitalDepartment of Radiation Oncology, Heidelberg University HospitalDepartment of Radiation Oncology, Heidelberg University HospitalDepartment of Radiation Oncology, Heidelberg University HospitalDivision of Radiology, German Cancer Research Center (DKFZ)Department of Radiation Oncology, Heidelberg University HospitalDepartment of Radiation Oncology, Heidelberg University HospitalDepartment of Radiation Oncology, Heidelberg University HospitalDepartment of Radiation Oncology, Heidelberg University HospitalDepartment of Radiation Oncology, Heidelberg University HospitalInstitute of Medical Biometry (IMBI)Institute of Medical Biometry (IMBI)National Center for Tumor Diseases (NCT)Division of Radiology, German Cancer Research Center (DKFZ)Department of Radiation Oncology, University Hospital, LMU MunichDepartment of Radiation Oncology, University Hospital, LMU MunichDepartment of Radiation Oncology, Heidelberg University HospitalDepartment of Radiation Oncology, Heidelberg University HospitalDepartment of Radiation Oncology, Heidelberg University HospitalAbstract Background Stereotactic body radiotherapy (SBRT) is an established local treatment method for patients with hepatic oligometastasis or oligoprogression. 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. Methods This trial is conducted as a prospective, randomized, three-armed phase II study in 82 patients with hepatic metastases (solid malignant tumor, 1–3 hepatic metastases confirmed by magnetic resonance imaging (MRI), maximum diameter of each metastasis ≤ 5 cm (in case of 3 metastases: sum of diameters ≤ 12 cm), age ≥ 18 years, Karnofsky Performance Score ≥ 60%). If a biologically effective dose (BED) ≥ 100 Gy (α/β = 10 Gy) 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 ≥ 100 Gy, the patient will be treated with MRgRT at the highest possible dose. Primary endpoint is the non-inferiority of MRgRT at the MRIdian Linac® 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. Discussion 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. Trial registration The study has been prospectively registered on August 30th, 2021: Clinicaltrials.gov, “Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases (MAESTRO)”, NCT05027711.https://doi.org/10.1186/s13014-022-02033-2Liver metastasesStereotactic body radiotherapy (SBRT)MR-guided radiotherapyMR-LinacMRIITV |
| spellingShingle | P. Hoegen K. S. Zhang E. Tonndorf-Martini F. Weykamp S. Regnery P. Naumann K. Lang J. Ristau S. A. Körber C. Dreher C. Buchele C. Rippke C. K. Renkamp K. M. Paul L. König C. Büsch J. Krisam O. Sedlaczek H.-P. Schlemmer M. Niyazi S. Corradini J. Debus S. Klüter J. Hörner-Rieber MR-guided adaptive versus ITV-based stereotactic body radiotherapy for hepatic metastases (MAESTRO): a randomized controlled phase II trial Radiation Oncology Liver metastases Stereotactic body radiotherapy (SBRT) MR-guided radiotherapy MR-Linac MRI ITV |
| title | MR-guided adaptive versus ITV-based stereotactic body radiotherapy for hepatic metastases (MAESTRO): a randomized controlled phase II trial |
| title_full | MR-guided adaptive versus ITV-based stereotactic body radiotherapy for hepatic metastases (MAESTRO): a randomized controlled phase II trial |
| title_fullStr | MR-guided adaptive versus ITV-based stereotactic body radiotherapy for hepatic metastases (MAESTRO): a randomized controlled phase II trial |
| title_full_unstemmed | MR-guided adaptive versus ITV-based stereotactic body radiotherapy for hepatic metastases (MAESTRO): a randomized controlled phase II trial |
| title_short | MR-guided adaptive versus ITV-based stereotactic body radiotherapy for hepatic metastases (MAESTRO): a randomized controlled phase II trial |
| title_sort | mr guided adaptive versus itv based stereotactic body radiotherapy for hepatic metastases maestro a randomized controlled phase ii trial |
| topic | Liver metastases Stereotactic body radiotherapy (SBRT) MR-guided radiotherapy MR-Linac MRI ITV |
| url | https://doi.org/10.1186/s13014-022-02033-2 |
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