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NCT07671768
Magnetic Resonance-Guided Stereotactic Body Radiation Therapy for the Treatment of Metastatic Solid Tumors, ONE SHOT Trial
Conditions: Metastatic Malignant Solid Neoplasm
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: Jonsson Comprehensive Cancer Center
Location: UCLA / Jonsson Comprehensive Cancer Center Los Angeles California
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07671768). StuddyBuddy aggregates publicly available trial information.