CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 114 target
Drug / intervention
Magnetic resonance (MR)-guided stereotactic ablative single-fraction (SBRT)radiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06362395
NCT06362395Phase 3RecruitingOn TrackUpdated 3mo ago

Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction

University Health Network, Toronto·interventional·Posted Apr 12, 2024·Updated Mar 4, 2026

In Brief

A Phase 3 clinical trial evaluating Magnetic resonance (MR)-guided stereotactic ablative single-fraction (SBRT) for Liver Metastases. Currently recruiting, targeting 114 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 3Recruiting
2025202620272028202920302031
First PostedApr 12, 2024
Enrollment StartDec 5, 2024
Primary CompletionSep 1, 2031
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 2.2 years agoPrimary completion in 5.2 years

Interventions

Magnetic resonance (MR)-guided stereotactic ablative single-fraction (SBRT)radiation

Precise radiation therapy delivered in a single session using magnetic resonance imaging for guidance.