Magnetic Resonance-Guided Stereotactic Body Radiation Therapy for the Treatment of Metastatic Solid Tumors, ONE SHOT Trial
2026年8月20日 更新者：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.
研究概览
地位
尚未招聘
条件
详细说明
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.
研究类型
介入性
注册 (估计的)
25
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Carol Felix
- 电话号码：310-825-9771
- 邮箱：cfelix@mednet.ucla.edu
研究联系人备份
- 姓名：Christy Palodichuk
- 电话号码：1 310-794-2971
- 邮箱：cpalodichuk@mednet.ucla.edu
学习地点
-
-
California
-
Los Angeles、California、美国、90095
- UCLA / Jonsson Comprehensive Cancer Center
-
接触：
- Christy Palodichuk
- 电话号码：310-794-2971
- 邮箱：cpalodichuk@mednet.ucla.edu
-
接触：
- Care Felix
- 电话号码：+1 310-825-9771
- 邮箱：cfelix@mednet.ucla.edu
-
首席研究员：
- Ann Raldow, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
辅助研究
进行核磁共振
其他名称：
接受PET/CT
其他名称：
进行 CT 和/或 PET/CT
其他名称：
Undergo MR-guided SBRT
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Acute toxicity rate
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to local failure (Local control)
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Ann Raldow, MD、UCLA / Jonsson Comprehensive Cancer Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年12月1日
初级完成 (估计的)
2036年12月1日
研究完成 (估计的)
2038年12月1日
研究注册日期
首次提交
2026年6月16日
首先提交符合 QC 标准的
2026年6月23日
首次发布 (实际的)
2026年6月26日
研究记录更新
最后更新发布 (实际的)
2026年8月24日
上次提交的符合 QC 标准的更新
2026年8月20日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.