骨转移立体定向放疗减轻疼痛（PREST）：一项 III 期随机多中心试验。
Pain REduction with bone metastases STereotactic radiotherapy (PREST): A phase III randomized multicentric trial.
机构信息
Fondazione Policlinico Universitario "A. Gemelli" IRCCS, UOC di Radioterapia Oncologica, Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Rome, Italy.
Radiotherapy Unit, Fondazione di Ricerca e Cura 'Giovanni Paolo II'- Catholic University of Sacred Heart, Campobasso, Italy.
出版信息
Trials. 2019 Oct 28;20(1):609. doi: 10.1186/s13063-019-3676-x.
BACKGROUND
Palliative antalgic treatments represent an issue for clinical management and a challenge for scientific research. Radiotherapy (RT) plays a central role. Techniques such as stereotactic body radiotherapy (SBRT) were largely investigated in several phase 2 studies with good symptom response, becoming widely adopted. However, evidence from randomized, direct comparison of RT and SBRT is still lacking.
METHODS/DESIGN: The PREST trial was designed as an interventional study without medicinal treatment. It is a phase 3, open-label, multicentric trial randomized 1:1. Inclusion criteria include painful spinal bone metastases presenting with a pain level > 4 (or > 1 if being treated with an analgesic) on the Numeric Rating Scale (NRS); expected intermediate/high prognosis (greater than 6 months) according to the Mizumoto prognostic score; low spine instability neoplastic score (SINS) sores (< 7); magnetic resonance imaging (MRI) assessment of the bulky lesion. Patients will be assigned to either standard conventional radiotherapy involving 4 Gy × 5 fractions (fx) to the whole involved vertebra or SBRT by intensity modulated radiotherapy with simultaneous integrated boost (IMRT-SIB) involving 7 Gy × 3 fx to the whole involved vertebra + 10 Gy × 3 fx on the macroscopic lesion (gross tumor volume (GTV)). In the experimental arm, the GTV will be contoured by registration with baseline MRI.
DISCUSSION
The primary endpoint is overall pain reduction, defined in terms of variation between baseline and 3-month evaluation; pain will be measured using the NRS. Secondary endpoints include pain control duration; retreatment rates (after a minimum interval of 1 month); local control assessed with RECIST criteria; symptom progression free survival; progression-free survival; overall survival; and quality of life (at 0, 30, and 90 days). Accrual of 330 lesions is planned. The experimental arm is expected to have an improvement in overall pain response rates of 15% with respect to the standard arm (60% according to Chow et al. (Int J Radiat Oncol Biol Phys. 82(5):1730-7, 2012)).
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03597984 . Registered on July 2018.
背景
姑息性镇痛治疗是临床管理中的一个问题，也是科学研究的一个挑战。放射治疗（RT）起着核心作用。立体定向体部放疗（SBRT）等技术在几项 2 期研究中得到了广泛的研究，这些研究显示出良好的症状缓解效果，因此得到了广泛的应用。然而，RT 和 SBRT 的随机直接比较的证据仍然缺乏。
方法/设计：PREST 试验设计为无药物治疗的干预性研究。这是一项 3 期、开放标签、多中心随机试验，1:1 分组。纳入标准包括疼痛性脊柱骨转移，疼痛评分＞4（或正在使用镇痛药的患者＞1），采用数字评分量表（NRS）评估；根据 Mizumoto 预后评分，预计预后为中/高度（＞6 个月）；脊柱不稳肿瘤评分（SINS）低（＜7）；磁共振成像（MRI）评估大块病变。患者将被分配到标准常规放疗组或 SBRT 组。常规放疗组采用 4 Gy×5 次分割（fx）照射整个受累椎体，SBRT 组采用调强放疗同步整合boost（IMRT-SIB），7 Gy×3 fx 照射整个受累椎体+10 Gy×3 fx 照射大体肿瘤体积（GTV）。在实验组中，GTV 将通过与基线 MRI 配准来勾画。
讨论
主要终点是总体疼痛缓解，定义为基线与 3 个月评估之间的变化；疼痛将采用 NRS 进行测量。次要终点包括疼痛控制持续时间；再治疗率（至少间隔 1 个月后）；根据 RECIST 标准评估局部控制；症状无进展生存；无进展生存；总生存；以及生活质量（0、30 和 90 天）。计划纳入 330 个病变。与标准组相比，实验组的总体疼痛缓解率预计提高 15%（根据 Chow 等人的研究（Int J Radiat Oncol Biol Phys. 82(5):1730-7, 2012），缓解率为 60%）。
试验注册
ClinicalTrials.gov，NCT03597984。于 2018 年 7 月注册。
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