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

Official title

ONE SHOT: Single-Fraction Adaptive MR-Guided Radiation Therapy for Metastatic Solid Tumors

Overview

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.

Detailed 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 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.

Interventions

• Procedure Computed Tomography
  Undergo CT and/or PET/CT
• Procedure Magnetic Resonance Imaging
  Undergo MRI
• Radiation MRI-guided Stereotactic Body Radiation Therapy
  Undergo MR-guided SBRT
• Procedure Positron Emission Tomography
  Undergo PET/CT
• Other Questionnaire Administration
  Ancillary studies

Primary outcome measures

• Acute toxicity rate [Time frame: Up to 3 months post-radiation therapy]

Secondary outcome measures (6)

• Time to local failure (Local control) [Time frame: From end of study treatment to the presence of local or locoregional disease progression within the irradiated field, assessed up to 12 months]
• Progression-free survival [Time frame: 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]
• Overall survival [Time frame: From end of study treatment to death from any cause, assessed up to 12 months]
• Incidence of late grade ≥ 3 toxicities [Time frame: From 3 months post-radiation therapy up to 12 months post-radiation therapy]
• PROMIS-29 patient-reported health-related quality-of-life (HRQOL) [Time frame: Peritreatment/Periprocedural, 3 months post-treatment, and 12 months post-treatment]
• Total in-room time [Time frame: From patient entry to exit at the treatment console, approximately one day]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles

Identifiers

NCT: NCT07671768 · 26-0235 · NCI-2026-04081

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗