This clinical trial tests how well single session magnetic resonance imaging (MRI)-guided adaptive stereotactic ablative radiotherapy (SABR) works in treating patients with liver tumors. SABR is a highly precise form of radiation therapy that delivers focused, high-dose radiation to tumors while limiting damage to surrounding healthy tissue. In this study, treatment is planned and delivered in a single session rather than over multiple treatment days. Researchers are evaluating whether this single-session approach provides similar tumor control and liver safety compared to standard multi-session liver SABR.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07223307.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo AltoStatus: Active
Contact: Erqi Pollom
Phone: 650-498-0484
PRIMARY OBJECTIVES:
I. To determine whether MRI-guided SABR planned and delivered in one session for liver tumors is associated with similar local tumor control at 1 year following SABR compared to historical liver SABR controls.
II. To determine rates of worsening albumin-bilirubin (ALBI) grade within 90 days of completing SABR.
SECONDARY OBJECTIVES:
I. To determine 1-year rate of overall survival following SABR.
II. To determine rates of Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher nausea, vomiting, diarrhea, abdominal pain, anorexia at least possibly attributable to SABR.
III. To determine rates of CTCAE grade 2 or higher pneumonitis at least possibly attributable to SABR.
IV. To determine rates of CTCAE grade 2 or higher chest wall pain and rib fracture at least possibly attributable to SABR.
V. To compare health-related quality of life (HRQOL) following SABR (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 [EORTC QLQ-C30], Functional Assessment of Cancer Therapy-Hepatobiliary [FACT-Hep], Comprehensive Score for Financial Toxicity [COST-FACIT]).
VI. To determine the total treatment time from start of imaging to end of radiation delivery.
OUTLINE:
Patients undergo MRI-guided SABR over 30-60 minutes in a single fraction on day 1. Patients may also under computed tomography (CT) and/or positron emission tomography (PET) throughout the trial.
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorErqi Pollom
