Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Workflow Feasibility
研究概览
简要总结
This purpose of this study is to assess the feasibility of FLASH radiotherapy for the palliative treatment of painful bone metastases. FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.
详细描述
This clinical investigation is designed to assess the workflow feasibility of FLASH radiotherapy treatment in a clinical setting, as well as the toxicities, and pain relief when used to treat bone metastasis(-es) in the extremities (excluding feet, hands, wrists). FLASH radiotherapy has been shown in preclinical studies to cause less injury to surrounding normal tissues during radiation treatment, while still having similar tumor cell killing. Patients at least 18 years of age with painful bone metastases located in the limbs will be considered for the study. These patients represent an ideal population for a feasibility study of FLASH radiotherapy as they are known to benefit from the palliative effects of radiotherapy using single dose radiation regimens of 8Gy which is what is being used in this investigation. After treatment, patients will be assessed for pain response as well as any adverse side-effects of radiation. The workflow feasibility of the treatment will also be evaluated.
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
- •Patient age at least 18 years
- •Up to 3 painful bone metastasis(-es) in the extremities
- •Bone metastases that can be treated using pre-defined treatment field sizes (7.5 cm x 7.5 cm; 7.5 cm x 10 cm; 7.5 cm x 12 cm; 7.5 cm x 14 cm; 7.5 cm x 16 cm; 7.5 cm x 18 cm; 7.5 cm x 20 cm), without overlap of radiation fields
- •Life expectancy of >2 months (in the judgement of the investigator)
- •Patients who are able to comply with the protocol
- •Provision of signed and dated informed consent form
排除标准
- •Prior radiotherapy to the treatment site(s)
- •Lesions of the feet, hands, wrists are not eligible treatment sites for FLASH
- •More than 3 painful bone metastases of the limbs requiring palliative radiotherapy
- •Tumor lysis of >50% of the circumferential bone cortex, or other factors considered to place the subject at significant risk of pathologic fracture
- •Patients with bone fractures and/or metal implants in the treatment field
- •Patients who will receive cytotoxic chemotherapy within 1 week prior to or 1 week following their planned radiation treatment
- •Prior local therapy modality to the treatment site(s) within 2 weeks of study enrollment
- •Patients with pacemakers or other implanted devices at risk of malfunction during radiotherapy
- •Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical investigation
- •Patients at known risk of enhanced normal tissue sensitivity to radiotherapy due to inherited predisposition or documented comorbidity that might lead to hypersensitivity to ionizing radiation
- •Patients enrolled in any other clinical studies the investigator believes to be in conflict with this clinical investigation.
- •Patients who are pregnant or nursing
结局指标
主要结局
Workflow Feasibility
时间窗: Will be assessed within 4 weeks of subject enrollment.
Number of participants whose treatment was delayed by more than 7 business days from simulation to treatment when related to the investigational device (excluding delays due to patient or facility factors not related to study treatment). The investigational site staff will measure the number of days delay in time to treatment due to problems involving the investigational device. The workflow feasibility outcome measure is met for an individual subject if the delay is measured as less than 7 days. The outcome measure data table provides the mean and full range days of treatment delay for the 10 participants.
Assessment of Radiation-related Toxicities That Are Possibly, Probably, or Definitely Related to FLASH Radiotherapy.
时间窗: Assessed from start of treatment until subject death or lost to follow-up, up to 17.8 months
Toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. Toxicities will be classified per CTCAE version 5.0. The outcome measure data table summarizes the total number of adverse events possibly, probably, definitely related to treatment that were reported in the 10 participant cohort. Eleven adverse events were grade 1 and one adverse event was grade 2, as classified by CTCAE version 5.0.
次要结局
- Number of Participants Who Experienced a Pain Flare.(First 10 days post FLASH treatment)
- Number of Participants With Increased Use of Pain Medication in First 10 Days Post FLASH Treatment(Within 10 days after treatment.)
- Pain Relief(At 3 month follow up)