ONE SHOT: Single-Fraction Adaptive MR-Guided Radiation Therapy for Metastatic Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Acute toxicity rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Uncontrolled infection or major comorbidity
- •Pregnant or breastfeeding
- •MRI contraindication
- •Life expectancy < 3 months
结局指标
主要结局
Acute toxicity rate
时间窗: 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
次要结局
- Time to local failure (Local control)(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(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(From end of study treatment to death from any cause, assessed up to 12 months)
- Incidence of late grade ≥ 3 toxicities(From 3 months post-radiation therapy up to 12 months post-radiation therapy)
- PROMIS-29 patient-reported health-related quality-of-life (HRQOL)(Peritreatment/Periprocedural, 3 months post-treatment, and 12 months post-treatment)
- Total in-room time(From patient entry to exit at the treatment console, approximately one day)