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

ConditionMetastatic Malignant Solid Neoplasm
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Uncontrolled infection or major comorbidity

Pregnant or breastfeeding

MRI contraindication

Life expectancy < 3 months

Trial design

Design model

Single group

Treatments tested in this trial

  • Computed Tomography

    Procedure/Surgery

    Undergo CT and/or PET/CT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • MRI-guided Stereotactic Body Radiation Therapy

    Radiation

    Undergo MR-guided SBRT

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Treatment (MR-guided SBRT)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Acute toxicity rate

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

Time frame
Up to 3 months post-radiation therapy

Secondary outcomes

1

Time to local failure (Local control)

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.

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
2

Progression-free survival

Will be estimated via KM analysis. The median survival along with 95% confidence interval will also be reported.

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
3

Overall survival

Will be estimated via KM analysis. The median survival along with 95% confidence interval will also be reported.

Time frame
From end of study treatment to death from any cause, assessed up to 12 months
4

Incidence of late grade ≥ 3 toxicities

Assessed per CTCAE v5.0 for entire and sub-cohort, stratified by anatomic treatment site. Will be characterized via descriptive statistics.

Time frame
From 3 months post-radiation therapy up to 12 months post-radiation therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jonsson Comprehensive Cancer Center

Lead sponsor

Viewray Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: