McClelland Shearwood, Sun Yilun, Spratt Daniel E
Department of Radiation Oncology, University Hospitals Seidman Cancer Center Case Western Reserve University School of Medicine, Cleveland, OH, United States.
Department of Neurological Surgery, University Hospitals Seidman Cancer Center Case Western Reserve University School of Medicine, Cleveland, OH, United States.
Rep Pract Oncol Radiother. 2023 Jul 25;28(3):379-388. doi: 10.5603/RPOR.a2023.0037. eCollection 2023.
Approximately 40% of patients with metastatic cancer will have spinal metastatic disease. Historically treated with external beam radiation therapy (EBRT) with limited durability in pain control, the increased lifespan of this patient population has necessitated more durable treatment results via spine radiosurgery/stereotactic body radiation therapy (SBRT). The goal of this study is to assess three-month pain freedom rates via the Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) randomized trial.
This study is a prospective randomized three-arm phase II trial which will recruit patients with symptomatic spine metastases. All patients will be randomized to standard-of care SBRT (24 Gy in 2 fractions), single-fraction SBRT (19 Gy in 1 fraction), or EBRT (8 Gy in 1 fraction), with the primary endpoint of three-month pain freedom (using the Brief Pain Inventory). We expect that SPORTSMEN will help definitively answer the efficacy of spine SBRT versus EBRT for achieving pain freedom, while defining the safety and efficacy of 19 Gy single-fraction spine SBRT. Local control will be defined according to Spine Response Assessment in Neuro-Oncology (SPINO) criteria.
This is the first phase II trial to objectively assess optimal spine SBRT dosing in the treatment of symptomatic spine metastatic disease, while assessing spine SBRT versus EBRT. Findings should allow for better determination of the efficacy of two-fraction spine SBRT versus EBRT in the United States, as well as for the novel single-fraction 19 Gy spine SBRT regimen in patients with symptomatic spine metastases.
Clinicaltrials.gov identifier: NCT05617716 (registration date: November 14, 2022).
大约40%的转移性癌症患者会发生脊柱转移疾病。以往采用外照射放疗（EBRT）治疗，疼痛控制的持久性有限，随着这一患者群体寿命的延长，需要通过脊柱放射外科手术/立体定向体部放射治疗（SBRT）获得更持久的治疗效果。本研究的目的是通过脊柱转移性肿瘤症状性患者最佳放射外科治疗（SPORTSMEN）随机试验评估三个月无痛率。
本研究是一项前瞻性随机三臂II期试验，将招募有症状性脊柱转移的患者。所有患者将被随机分为标准护理SBRT组（24 Gy分2次）、单次分割SBRT组（19 Gy单次）或EBRT组（8 Gy单次），主要终点为三个月无痛（使用简明疼痛量表）。我们期望SPORTSMEN试验将有助于明确回答脊柱SBRT与EBRT在实现无痛方面的疗效，同时确定19 Gy单次分割脊柱SBRT的安全性和疗效。局部控制将根据神经肿瘤学中的脊柱反应评估（SPINO）标准进行定义。
这是第一项客观评估治疗有症状性脊柱转移疾病时最佳脊柱SBRT剂量，同时评估脊柱SBRT与EBRT的II期试验。研究结果应有助于更好地确定在美国两分割脊柱SBRT与EBRT的疗效，以及在有症状性脊柱转移患者中新型单次分割19 Gy脊柱SBRT方案的疗效。
Clinicaltrials.gov标识符：NCT05617716（注册日期：2022年11月14日）。
