protocolSection identificationModule nctId: NCT06362395, orgStudyIdInfo id: 24-5022, briefTitle: Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction, acronym: ULTRAS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2030-06, completionDateStruct date: 2030-06, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: This international multi-centre phase 3 randomized control trial investigates whether giving a very high dose of radiation in a single treatment session (ultra-high dose: experimental) using advanced technology called MR-Linac is more effective than a high dose (control) for treating liver tumors that have spread from other parts of the body (liver metastases). This study also aims to identify predictors of treatment response and side effects by analyzing various factors such as imaging markers and genetic profiles.Liver metastases are common in several cancers, but surgery is often not feasible for many patients. Stereotactic body radiotherapy (SBRT), which delivers focused radiation to tumors, is an alternative treatment option. Previous studies have shown promising results with SBRT, but the optimal radiation dose for liver metastases is still uncertain.This study will look at patients with specific types of primary cancers known to respond well to SBRT. Treatment effectiveness will be assessed by monitoring tumor control, overall survival, and quality of life.By comparing ultra-high dose SBRT with standard high dose, the study aims to determine if the former can provide better tumor control with fewer side effects. If successful, this approach could offer a significant advancement in the treatment of liver metastases, potentially improving outcomes and quality of life for patients., conditionsModule conditions: Liver Metastases, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule interventions name: Magnetic resonance (MR)-guided stereotactic ablative single-fraction (SBRT), outcomesModule primaryOutcomes measure: Local control (LC) of treated target lesion compared to high dose MR-guided stereotactic single-fraction radiation., secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Intra-hepatic progression, secondaryOutcomes measure: Widespread progression., secondaryOutcomes measure: Physician-assessed toxicities: National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.5., secondaryOutcomes measure: Patients-reported toxicity: Patient Reported Outcomes - Common Terminology Criteria of Adverse Events (PRO CTCAE) V.1., secondaryOutcomes measure: Quality of life (QOL): European Organization for Research and Treatment of Cancer Quality of Life Questionnaires, Core 15 for Palliative Care (EORTC QLQ-C15-PAL), secondaryOutcomes measure: Quality of life (QOL): European Organization for Research and Treatment of Cancer Quality of Life Questionnaires, liver metastases (EORTC QOQ-LM21)., otherOutcomes measure: Changes in the levels of circulating biomarkers (cell-free tumor DNA) in response to SBRT., otherOutcomes measure: Changes in the levels of circulating biomarkers (cytokines) in response to SBRT., otherOutcomes measure: Changes in the levels of circulating biomarkers (metabolites) in response to SBRT., otherOutcomes measure: Changes in the levels of circulating biomarkers (immune cell populations) in response to SBRT., otherOutcomes measure: Identification of MR imaging biomarkers in response to SBRT., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False