Magnetic Resonance-Guided Stereotactic Body Radiation Therapy for the Treatment of Metastatic Solid Tumors, ONE SHOT Trial
20 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
25
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Carol Felix
- Número de teléfono: 310-825-9771
- Correo electrónico: cfelix@mednet.ucla.edu
Copia de seguridad de contactos de estudio
- Nombre: Christy Palodichuk
- Número de teléfono: 1 310-794-2971
- Correo electrónico: cpalodichuk@mednet.ucla.edu
Ubicaciones de estudio
-
-
California
-
Los Angeles, California, Estados Unidos, 90095
- UCLA / Jonsson Comprehensive Cancer Center
-
Contacto:
- Christy Palodichuk
- Número de teléfono: 310-794-2971
- Correo electrónico: cpalodichuk@mednet.ucla.edu
-
Contacto:
- Care Felix
- Número de teléfono: +1 310-825-9771
- Correo electrónico: cfelix@mednet.ucla.edu
-
Investigador principal:
- Ann Raldow, MD
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
Estudios complementarios
Someterse a una resonancia magnética
Otros nombres:
Someterse a PET/CT
Otros nombres:
Someterse a TC y/o PET/TC
Otros nombres:
Undergo MR-guided SBRT
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Acute toxicity rate
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to local failure (Local control)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ann Raldow, MD, UCLA / Jonsson Comprehensive Cancer Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de diciembre de 2026
Finalización primaria (Estimado)
1 de diciembre de 2036
Finalización del estudio (Estimado)
1 de diciembre de 2038
Fechas de registro del estudio
Enviado por primera vez
16 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
23 de junio de 2026
Publicado por primera vez (Actual)
26 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de agosto de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-0235
- NCI-2026-04081 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .