背景:早期姑息性/先发制人干预可改善转移性癌症患者的临床预后和生活质量。先前的信号寻求随机对照试验(RCT)表明,对无症状或症状最小的高危骨转移进行早期前期放疗可减少骨骼相关事件(SRE)。主要由高危脊柱转移亚组驱动的益处。当前的RCT旨在确定高风险患者的早期姑息性/先发制人性放疗,无症状或症状轻微的脊柱转移将导致1年内SRE减少.
方法:这是一个单中心,平行臂,在ECOG表现状态0-2且无症状或症状轻微(不需要阿片类药物)的成人(≥18岁)中进行RCT,这些患者是组织学证实的具有>5个转移部位的实体瘤恶性肿瘤的高危脊柱转移患者。高危脊柱转移由以下定义:(a)最大的疾病部位≥2cm;(b)交界性疾病(枕骨至C2,C7-T1,T12-L2,L5-S1);(c)后部元件受累;或(d)椎体压缩畸形>50%。患者以1:1的比例随机分配接受标准护理系统治疗(第1组)或前期治疗,对≤5个高危脊柱病变的早期放疗加标准护理系统治疗(第2组),以2-10个部分的20-30Gy辐射的形式。主要终点是SRE,包括脊柱骨折在内的复合结局,脊髓压迫,需要姑息性放疗,介入程序,或者脊柱手术.次要终点包括(1)医疗保健成本的替代,包括SRE相关住院次数和持续时间;(2)总生存期;(3)无痛生存期;(4)生活质量.研究仪器将被捕获预处理,在基线,治疗期间,以及治疗后1、3、6、12和24个月。该试验旨在累积74名患者超过2年,使用双样本比例检验(α<0.05)检测差异的能力>80%。
结论:此RCT的结果将证明其价值,如果有的话,早期放射治疗高危脊柱转移瘤。该试验已获得IRB批准,资金,和预期注册(NCT05534321),自2022年8月19日起开始计提。如果是积极的,该试验将扩大脊柱放射治疗的范围和实用性。
背景:临床试验。政府NCT05534321。2022年9月9日注册。
方法:协议2.0版(2021-KOT-002),最后修订于2022年9月2日,由WCG机构审查委员会批准(研究编号1337188,IRB跟踪编号20223735)。该试验首次发布在临床试验上。政府,2022年9月9日(NCT05534321)。患者招募于2022年8月19日开始,预计将在2年内完成。可能是2024年8月。
BACKGROUND: Early palliative/pre-emptive intervention improves clinical outcomes and quality of life for patients with metastatic cancer. A previous signal-seeking randomized controlled trial (RCT) demonstrated that early upfront radiotherapy to asymptomatic or minimally symptomatic high-risk osseous metastases led to reduction in skeletal-related events (SREs), a benefit driven primarily by subgroup of high-risk spine metastasis. The current RCT aims to determine whether early palliative/pre-emptive radiotherapy in patients with high-risk, asymptomatic or minimally symptomatic spine metastases will lead to fewer SREs within 1 year.
METHODS: This is a single-center, parallel-arm, in-progress RCT in adults (≥ 18 years) with ECOG performance status 0-2 and asymptomatic or minimally symptomatic (not requiring opioids) high-risk spine metastases from histologically confirmed solid tumor malignancies with > 5 sites of metastatic disease on cross-sectional imaging. High-risk spine metastases are defined by the following: (a) bulkiest disease sites ≥ 2 cm; (b) junctional disease (occiput to C2, C7-T1, T12-L2, L5-S1); (c) posterior element involvement; or (d) vertebral body compression deformity > 50%. Patients are randomized 1:1 to receive either standard-of-care systemic therapy (arm 1) or upfront, early radiotherapy to ≤ 5 high-risk spine lesions plus standard-of-care systemic therapy (arm 2), in the form of 20-30 Gy of radiation in 2-10 fractions. The primary endpoint is SRE, a composite outcome including spinal fracture, spinal cord compression, need for palliative radiotherapy, interventional procedures, or spinal surgery. Secondary endpoints include (1) surrogates of health care cost, including the number and duration of SRE-related hospitalizations; (2) overall survival; (3) pain-free survival; and (4) quality of life. Study instruments will be captured pre-treatment, at baseline, during treatment, and at 1, 3, 6, 12, and 24 months post-treatment. The trial aims to accrue 74 patients over 2 years to achieve > 80% power in detecting difference using two-sample proportion test with alpha < 0.05.
CONCLUSIONS: The results of this RCT will demonstrate the value, if any, of early radiotherapy for high-risk spine metastases. The trial has received IRB approval, funding, and prospective registration (NCT05534321) and has been open to accrual since August 19, 2022. If positive, the trial will expand the scope and utility of spine radiotherapy.
BACKGROUND: ClinicalTrials.Gov NCT05534321 . Registered September 9, 2022.
METHODS: Version 2.0 of the protocol (2021-KOT-002), revised last on September 2, 2022, was approved by the WCG institutional review board (Study Number 1337188, IRB tracking number 20223735). The trial was first posted on ClinicalTrials.Gov on September 9, 2022 (NCT05534321). Patient enrollment commenced on August 19, 2022, and is expected to be completed in 2 years, likely by August 2024.