Magnetic Resonance-Guided Stereotactic Body Radiation Therapy for the Treatment of Metastatic Solid Tumors, ONE SHOT Trial
20 augusti 2026 uppdaterad av: Jonsson Comprehensive Cancer Center
ONE SHOT: Single-Fraction Adaptive MR-Guided Radiation Therapy for Metastatic Solid Tumors
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
25
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Carol Felix
- Telefonnummer: 310-825-9771
- E-post: cfelix@mednet.ucla.edu
Studera Kontakt Backup
- Namn: Christy Palodichuk
- Telefonnummer: 1 310-794-2971
- E-post: cpalodichuk@mednet.ucla.edu
Studieorter
-
-
California
-
Los Angeles, California, Förenta staterna, 90095
- UCLA / Jonsson Comprehensive Cancer Center
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Kontakt:
- Christy Palodichuk
- Telefonnummer: 310-794-2971
- E-post: cpalodichuk@mednet.ucla.edu
-
Kontakt:
- Care Felix
- Telefonnummer: +1 310-825-9771
- E-post: cfelix@mednet.ucla.edu
-
Huvudutredare:
- Ann Raldow, MD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Treatment (MR-guided SBRT)
Patients undergo MR-guided SBRT over one treatment fraction on study.
Patients also undergo MRI and CT on study and CT or PET/CT throughout the study.
|
Sidostudier
Genomgå MRI
Andra namn:
Genomgå PET/CT
Andra namn:
Genomgå CT och/eller PET/CT
Andra namn:
Undergo MR-guided SBRT
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Acute toxicity rate
Tidsram: Up to 3 months post-radiation therapy
|
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
|
Up to 3 months post-radiation therapy
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to local failure (Local control)
Tidsram: From end of study treatment to the presence of local or locoregional disease progression within the irradiated field, assessed up to 12 months
|
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.
|
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
Tidsram: 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
|
Will be estimated via KM analysis.
The median survival along with 95% confidence interval will also be reported.
|
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
Tidsram: From end of study treatment to death from any cause, assessed up to 12 months
|
Will be estimated via KM analysis.
The median survival along with 95% confidence interval will also be reported.
|
From end of study treatment to death from any cause, assessed up to 12 months
|
|
Incidence of late grade ≥ 3 toxicities
Tidsram: From 3 months post-radiation therapy up to 12 months post-radiation therapy
|
Assessed per CTCAE v5.0 for entire and sub-cohort, stratified by anatomic treatment site.
Will be characterized via descriptive statistics.
|
From 3 months post-radiation therapy up to 12 months post-radiation therapy
|
|
PROMIS-29 patient-reported health-related quality-of-life (HRQOL)
Tidsram: Peritreatment/Periprocedural, 3 months post-treatment, and 12 months post-treatment
|
Assessed using PROMIS-29 HRQOL questionnaires (Patient-Reported Outcomes Measurement Information System 29-item profile).
Raw domain scores are converted to T-scores calibrated to the US general population, with a mean of 50 and standard deviation of 10.
For symptom domains (anxiety, depression, fatigue, pain interference, sleep disturbance), higher scores indicate worse symptom burden.
For functioning domains (physical function, social participation), higher scores indicate better functioning.
Changes from baseline to 3 time points post-treatment will be analyzed.
|
Peritreatment/Periprocedural, 3 months post-treatment, and 12 months post-treatment
|
|
Total in-room time
Tidsram: From patient entry to exit at the treatment console, approximately one day
|
The duration from patient entry to exit at the treatment console will be collected; summary statistics will be reported for entire cohort and sub-cohort of treated target number 1, 2 and 3, respectively.
|
From patient entry to exit at the treatment console, approximately one day
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Ann Raldow, MD, UCLA / Jonsson Comprehensive Cancer Center
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 december 2026
Primärt slutförande (Beräknad)
1 december 2036
Avslutad studie (Beräknad)
1 december 2038
Studieregistreringsdatum
Först inskickad
16 juni 2026
Först inskickad som uppfyllde QC-kriterierna
23 juni 2026
Första postat (Faktisk)
26 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 augusti 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 26-0235
- NCI-2026-04081 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Nej
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