This trial studies how well stereotactic magnetic resonance imaging (MRI)-guided adaptive radiotherapy (SMART) works in treating patients with cancer that has spread to the spine (spinal metastases). Radiation therapy is a standard treatment for cancer that has spread to the spine. Before radiation therapy to the spine can begin, an image of the spine must be taken using computed tomography (CT), which may result in weeks of delay. SMART uses a device that can deliver radiation and an MRI scanner, so that imaging and treatment can take place on the same day. This trial is being done to see if SMART can plan and deliver treatment faster to patients with cancer that has spread to the spine so that less time passes from consultation visit to the start of treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03878485.
PRIMARY OBJECTIVE:
I. Demonstrate that same-session MRI-only simulation and treatment with stereotactic MRI-guided radiotherapy (SMART) for spinal oligometastases is feasible by confirming that the first fraction of same-session MRI-only simulation and treatment with SMART can be delivered on the first on-table attempt for at least 70% of patients.
EXPLORATORY OBJECTIVES:
I. Determine the average time (days) from patient consult appointment to successful delivery of the first treatment fraction.
II. Determine the local, in-field tumor response and control rates at three months.
III. Demonstrate that same-session magnetic resonance (MR)-only simulation and treatment with SMART for treatment of spinal metastases will lead to comparable toxicities compared with historically reported rates using standard, computed tomography (CT)-based stereotactic body radiation therapy (SBRT) assessed prospectively at three months post-treatment and retrospectively for later time-points.
IV. Determine the projected dosimetric differences between the study method of MRI-only planning using standard bulk density override dose calculations (which will be clinically used for all patients) and an exploratory alternative method of a novel voxel-by-voxel MRI-based dose calculation using an institutionally developed machine learning algorithm (which will be simulated for comparison but not used in clinical treatment planning).
V. Determine the on-table time required for same-session MR-only simulation and treatment with plan generation for the initial treatment fraction and for subsequent treatment fractions.
OUTLINE:
Patients undergo SMART once daily (QD) or once every other day over 1-1.5 hours for a total of 5 treatments over 1 to 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorClifford G. Robinson
