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

About

Brief 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.

Primary Purpose
The main objective of the intervention(s) being evaluated by the clinical trial. Learn more
Treatment
Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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
Study Stats
Protocol No.
26-0235
Category
Other Cancer
Principal Investigator
Ann C. Raldow, MD, MPH
Ann C. Raldow, MD, MPH
Radiation Oncology
Ann C. Raldow, MD, MPH
Contact
  • Carol Felix
  • Madeleine Zonana
Location
  • UCLA Santa Clarita
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT07671768
For detailed technical eligibility, visit ClinicalTrials.gov.