ONE SHOT: Single-Fraction Adaptive MR-Guided Radiation Therapy for Metastatic Solid Tumors
Jonsson Comprehensive Cancer Center
Summary
This clinical trial studies the side effects of magnetic resonance (MR)-guided stereotactic body radiation therapy (SBRT) and to see how well it works in treating patients with solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body. The total dose of radiation is divided into smaller doses given over 1-5 days. This type of radiation therapy helps spare normal tissue. During MR-guided SBRT, MR imaging is used to define and localize the area to be treated and provide more accurate delivery. This allows the treatment to be given over one day. MR-guided SBRT may be safe, tolerable, and/or effective in treating patients with metastatic solid tumors. Tumors in the central nervous system will not be treated on this study.
Description
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 treatme…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 aminotransfe…
Interventions
- ProcedureComputed Tomography
Undergo CT and/or PET/CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- RadiationMRI-guided Stereotactic Body Radiation Therapy
Undergo MR-guided SBRT
- ProcedurePositron Emission Tomography
Undergo PET/CT
- OtherQuestionnaire Administration
Ancillary studies
Location
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California