Contemporary clinical trials · 2026
Ultra-high dose radiation for Liver metastasis using MR-guided TReatment with stereotactic Ablative Single-fraction (ULTRAS): study protocol for a phase III randomized controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Wong Harroun, Ng Sylvia S W, Mohamad Issa, Alborz Jooya, Stanescu Teodor, Liu Zhihui Amy, De Leon Jeremy, Tan Hendrick, Ng Sweet Ping, Radhakrishna Ganesh, Bahij Rana, Intven Martijn, Kirichenko Alexander, Mesci Aruz, Yan Michael, Dawson Laura, Augilera Todd, Hosni Ali
Аннотация
INTRODUCTION: Liver metastases are common in several malignancies, with only 15-20% of patients eligible for surgical resection. For non-surgical candidates, stereotactic body radiation therapy (SBRT) is an effective alternative with acceptable local control (LC) rates. Higher biologically effective doses (BED10 > 100 Gy10) are associated with improved LC, and single-fraction ultra-high dose SBRT (35-40 Gy) has demonstrated excellent LC with minimal toxicity. MR-guided adaptive SBRT enhances precision and may optimizing single-fraction SBRT for liver metastases.
METHODS AND ANALYSIS: ULTRAS is a multi-center, phase III randomized trial evaluating whether ultra-high dose MR-guided single-fraction SBRT (38 Gy, BED10 ≈ 180 Gy10) improves LC of liver oligometastases/oligoprogression compared to high-dose MR-guided single-fraction SBRT (27 Gy, BED10 ≈ 100 Gy10). Primary endpoint is LC of treated intrahepatic target lesion(s). Secondary endpoints include overall survival (OS), progression-free survival (PFS), intrahepatic and extrahepatic progression, toxicity (CTCAE v5.0 and PRO-CTCAE v1.0), and quality of life (QOL) (EORTC QLQ-C15-PAL, EORTC QLQ-LM21). Patients will be randomized 1:1 to receive either 27 Gy or 38 Gy, stratified by primary tumor site/histology, lesion characteristics, and prior systemic therapy. A total of 114 patients (57 per arm) will be enrolled over three years, with two years of follow-up. Assessments at predefined intervals will monitor response and toxicity. LC will be analyzed using cumulative incidence function. Widespread and intrahepatic progression will be assessed using Fine & Gray regression; OS and PFS via Cox models; toxicity and QOL via Chi-squared test and mixed-effects model.
ETHICS AND DISSEMINATION: The ULTRAS trial obtained ethical approval from the University Health Network and will follow ICMJE reporting standards.
TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT06362395.
METHODS AND ANALYSIS: ULTRAS is a multi-center, phase III randomized trial evaluating whether ultra-high dose MR-guided single-fraction SBRT (38 Gy, BED10 ≈ 180 Gy10) improves LC of liver oligometastases/oligoprogression compared to high-dose MR-guided single-fraction SBRT (27 Gy, BED10 ≈ 100 Gy10). Primary endpoint is LC of treated intrahepatic target lesion(s). Secondary endpoints include overall survival (OS), progression-free survival (PFS), intrahepatic and extrahepatic progression, toxicity (CTCAE v5.0 and PRO-CTCAE v1.0), and quality of life (QOL) (EORTC QLQ-C15-PAL, EORTC QLQ-LM21). Patients will be randomized 1:1 to receive either 27 Gy or 38 Gy, stratified by primary tumor site/histology, lesion characteristics, and prior systemic therapy. A total of 114 patients (57 per arm) will be enrolled over three years, with two years of follow-up. Assessments at predefined intervals will monitor response and toxicity. LC will be analyzed using cumulative incidence function. Widespread and intrahepatic progression will be assessed using Fine & Gray regression; OS and PFS via Cox models; toxicity and QOL via Chi-squared test and mixed-effects model.
ETHICS AND DISSEMINATION: The ULTRAS trial obtained ethical approval from the University Health Network and will follow ICMJE reporting standards.
TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT06362395.