Magnetic Resonance-Guided Stereotactic Body Radiation Therapy for the Treatment of Metastatic Solid Tumors, ONE SHOT Trial

PRIMARY OBJECTIVE:

I. To evaluate the incidence of acute grade ≥ 3 adverse events that are possibly, probably, or definitely related to single-fraction adaptive MR-guided SBRT.

SECONDARY OBJECTIVES:

I. To estimate local control (LC), progression-free survival (PFS) and overall survival (OS).

II. To characterize late grade ≥ 3 toxicity rates per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

III. To assess patient-reported health-related quality of life (HRQOL) using Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) at baseline, end of treatment, 3 months post-treatment, and 1 year post-treatment.

IV. To measure total in-room time, defined as the duration from patient entry to exit at the treatment console.

OUTLINE:

Patients undergo MR-guided SBRT over one treatment fraction on study. Patients also undergo magnetic resonance imaging (MRI) and computed tomography (CT) on study and CT or PET/CT throughout the study.

After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.

• Computed Tomography (Procedure), also known as CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography: Undergo CT and/or PET/CT
• Magnetic Resonance Imaging (Procedure), also known as Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI: Undergo MRI
• MRI-guided Stereotactic Body Radiation Therapy (Radiation), also known as Magnetic Resonance Imaging-guided Stereotactic Body Radiation Therapy, MR-guided SBRT, MRI-guided SBRT: Undergo MR-guided SBRT
• Positron Emission Tomography (Procedure), also known as Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT: Undergo PET/CT
• Questionnaire Administration (Other): Ancillary studies

Primary outcomes

• Acute toxicity rate [Up to 3 months post-radiation therapy]: Defined as the percentage of patients who experience acute grade ≥ 3 adverse events relating to single-fraction adaptive magnetic resonance-guided stereotactic body radiation therapy. Will be calculated, along with the corresponding 95% Clopper-Pearson exact confidence interval. Assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0

Secondary outcomes

• Time to local failure (Local control) [From end of study treatment to the presence of local or locoregional disease progression within the irradiated field, assessed up to 12 months]: As assessed by imaging and clinical evaluation, according to Response Evaluation Criteria in Solid Tumors version 1.1. Will be estimated via Kaplan-Meier (KM) analysis. The median survival along with 95% confidence interval will also be reported.
• Progression-free survival [From end of study treatment to the first documented evidence of disease progression or death from any cause, whichever occurs first, assessed up to 12 months]: Will be estimated via KM analysis. The median survival along with 95% confidence interval will also be reported.
• Overall survival [From end of study treatment to death from any cause, assessed up to 12 months]: Will be estimated via KM analysis. The median survival along with 95% confidence interval will also be reported.
• Incidence of late grade ≥ 3 toxicities [From 3 months post-radiation therapy up to 12 months post-radiation therapy]: Assessed per CTCAE v5.0 for entire and sub-cohort, stratified by anatomic treatment site. Will be characterized via descriptive statistics.
• PROMIS-29 patient-reported health-related quality-of-life (HRQOL) [Peritreatment/Periprocedural, 3 months post-treatment, and 12 months post-treatment]: Assessed using PROMIS-29 HRQOL questionnaires (Patient-Reported Outcomes Measurement Information System 29-item profile). Raw domain scores are converted to T-scores calibrated to the US general population, with a mean of 50 and standard deviation of 10. For symptom domains (anxiety, depression, fatigue, pain interference, sleep disturbance), higher scores indicate worse symptom burden. For functioning domains (physical function, social participation), higher scores indicate better functioning. Changes from baseline to 3 time points post-treatment will be analyzed.
• Total in-room time [From patient entry to exit at the treatment console, approximately one day]: The duration from patient entry to exit at the treatment console will be collected; summary statistics will be reported for entire cohort and sub-cohort of treated target number 1, 2 and 3, respectively.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Histologically confirmed metastatic solid tumor (any primary site)
* 1-3 metastases ≤ 5 cm each located outside the brain and spine
* Lesions treatable at 25-30 Gy × 1 fraction with MR guidance
* No overlapping prior radiation
* Absolute neutrophil count (ANC) > 1.5 cell/mm\^3
* Hemoglobin (Hgb) > 8.0 gm/dL
* Platelet (PLT) > 150,000/mm\^3
* Total bilirubin < or equal to 1.5 x upper limit of normal
* Aspartate aminotransferase (AST) < or equal to three times upper limit of normal
* Alanine aminotransferase (ALT) < or equal to three times upper limit of normal
* Informed consent obtained

Exclusion Criteria:

* Uncontrolled infection or major comorbidity
* Pregnant or breastfeeding
* MRI contraindication
* Life expectancy < 3 months

• Ann Raldow, MD, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center