A Pilot Study of BgRT for Bone Metastases
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This clinical trial tests the safety and effectiveness of a single-dose treatment of biology-guided radiation therapy (BgRT) in treating patients with painful cancer that has spread from where it first started (primary site) to the bone (bone metastases). Bone metastases can result in significant pain and reduction in quality of life. Single fraction radiation therapy (SFRT) can produce equivalent pain relief compared to multi-fraction radiation therapy, but SFRT treatments generally lead to higher rates of retreatment. BgRT is a new and innovative form of radiation delivery that uses a signal generated by positron emission tomography to guide external beam radiation therapy. It is a technology breakthrough that uses live, continuously updated data throughout the entire treatment session to determine exactly where to deliver radiotherapy to biologically active tumors. Giving BgRT may be safe and effective in treating patients with painful bone metastases.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate pain response by 14 gray (Gy) single fraction (SF)-BgRT for patients with painful bone metastases.
SECONDARY OBJECTIVE:
I. To evaluate patient-reported health related quality of life (QOL), clinician-rated toxicity per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0, radiographic evidence of disease progression at treated sites, and rate of re-irradiation.
OUTLINE:
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
- •Documented informed consent of the participant and/or legally authorized representative
- •Assent, when appropriate, will be obtained per institutional guidelines
- •Age: ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Pathologic diagnosis of cancer
- •Painful bone metastases from any solid cancers (i.e., a score of at least 2 on a 0-10 scale, 0 representing no pain and 10 representing maximum pain)
- •Concurrent treatment of up to 3 radiation fields is allowed
- •Standardized uptake value maximum (SUVmax) of the target bone lesions on diagnostic PET > 6
- •Size of the target bone lesion 1.5-5 cm
- •Pre-screening assessment confirms that the intervention can be administered without exceeding dose constraint guidelines
- •Patients with brain metastases can be included but brain metastases must be treated prior to enrollment and follow up magnetic resonance imaging (MRI) 3 months after treatment shows stable findings
- •Life expectancy ≥ 6 months in the opinion of the treating investigators
- •Off systemic therapy for at least one week prior and one week after study intervention
- •Patients able to complete pain assessment and quality of life surveys who do not have cognitive impairment
排除标准
- •Patients with prior radiation therapy to the treatment sites
- •Untreated spinal cord compression
- •Pathologic fracture at the evaluated site
- •Serious medical comorbidities precluding radiotherapy
- •Unable to undergo a PET/CT scan
- •Pregnant and/or breastfeeding women are excluded from this study as these agents may have the potential for teratogenic or abortifacient effects
- •Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
- •Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics, patients who exhibit cognitive impairments/ who are unable to complete study materials: assessments/questionnaires)
研究组 & 干预措施
Treatment (BgRT)
Patients undergo a single fraction of BgRT on day 0. Patients undergo PET/CT on study and optionally during follow up.
干预措施: Computed Tomography (Procedure)
Treatment (BgRT)
Patients undergo a single fraction of BgRT on day 0. Patients undergo PET/CT on study and optionally during follow up.
干预措施: Image Guided Radiation Therapy (Radiation)
Treatment (BgRT)
Patients undergo a single fraction of BgRT on day 0. Patients undergo PET/CT on study and optionally during follow up.
干预措施: Positron Emission Tomography (Procedure)
Treatment (BgRT)
Patients undergo a single fraction of BgRT on day 0. Patients undergo PET/CT on study and optionally during follow up.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 1 year follow-up
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicity is defined as any ≥ grade 3 gastrointestinal, genitourinary, lung, or skeletomuscular toxicities that is considered at least possibly related to the study treatment and occurs within 3 months after the treatment.
Pain response
时间窗: Up to 1 year follow-up
Will be assessed using international consensus endpoints assessing a combination of pain severity and analgesic consumption. Pain progression reflects either (a) an increase in a worst-pain score of 2 or more without reduced daily morphine milligram equivalent (MME), or (b) no change in worst-pain score or 1 point above baseline and an increase in daily MME of at least 25%. Indeterminate response then indicates all other responses. Overall response is defined as sum of complete response and partial response at 3 months after single fraction-biology-guided radiation therapy.
次要结局
- Rates of re-irradiation(At 1 year follow-up)
- Radiographic evidence of disease progression(Up to 1 year follow-up)
- Patient-reported health related quality of life (QOL)(Up to 1 year follow-up)
- Incidence of clinician-related chronic toxic effects(Up to 1 year follow-up)