A randomized phase III trial of stereotactic ablative radiotherapy for patients with up to 10 oligometastases and a synchronous primary tumor (SABR-SYNC): study protocol.
David A Palma, Meredith E Giuliani, Rohann J M Correa, Famke L Schneiders, Stephen Harrow, Matthias Guckenberger, Tina Zhang, Houda Bahig, Sashendra Senthi, Peter Chung, Robert Olson, Michael Lock, Srinivas Raman, Glenn S Bauman, Benjamin H Lok, Joanna M Laba, Rachel M Glicksman, Timothy K Nguyen, Pencilla Lang, Joelle Helou, Christopher D Goodman, Lucas C Mendez, Peter S N van Rossum, Andrew Warner, Stewart Gaede, Alison L Allan
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引用次数: 0
Abstract
Background: Emerging randomized data, mostly from phase II trials, have suggested that patients with oligometastatic cancers may benefit from ablative treatments such as stereotactic ablative radiotherapy (SABR). However, phase III data testing this paradigm are lacking, and many studies have examined SABR in the setting of metachronous oligometastatic disease. The goal of the SABR-SYNC trial is to assess the effect of SABR in patients with oligometastatic cancers and a synchronous primary tumor.
Methods: One hundred and eighty patients will be randomized in a 1:2 ratio between standard of care (SOC) palliative-intent treatments vs. SOC + ablative therapy (SABR preferred) to all sites of known disease. Randomization will be stratified based on histology and number of metastases at enrollment. SABR may be delivered in 1-, 3- and 5-fraction regimens, with recommended doses of 20 Gy, 30 Gy, and 35 Gy, respectively. Non-SABR local modalities (e.g. surgery, thermal ablation, conventional radiation) may be used for treatment of the primary or metastases at the discretion of the treating physicians, if those modalities are clinically preferred. The primary endpoint is overall survival, and secondary endpoints include progression-free survival, time to development of new metastatic lesions, time to initiation of next systemic therapy, quality of life, and toxicity. Translational endpoints include assessment of circulating tumor DNA and immunological predictors of outcomes.
Discussion: SABR-SYNC will provide phase III data to assess the impact of SABR on overall survival in a population of patients with synchronous oligometastases. The translational component will attempt to identify novel prognostic and predictive biomarkers to aid in clinical decision making.
针对多达 10 个少转移灶和同步原发肿瘤患者的立体定向消融放疗（SABR-SYNC）随机 III 期试验：研究方案。
背景：新出现的随机数据（大部分来自 II 期试验）表明，寡转移性癌症患者可能会从立体定向消融放疗（SABR）等消融治疗中获益。然而，目前还缺乏对这一模式进行测试的 III 期数据，而且许多研究都是在转移性少转移性疾病的情况下对 SABR 进行检查。SABR-SYNC试验的目标是评估SABR对少转移癌和同步原发肿瘤患者的效果：180名患者将按1:2的比例随机接受标准护理（SOC）姑息治疗与SOC+消融治疗（首选SABR），治疗范围包括已知疾病的所有部位。随机化将根据组织学和入组时的转移灶数量进行分层。SABR可采用1-、3-和5-分次疗法，推荐剂量分别为20 Gy、30 Gy和35 Gy。非 SABR 局部模式（如手术、热消融、传统放射治疗）可用于原发灶或转移灶的治疗，但须由主治医生根据临床情况决定是否采用。主要终点是总生存期，次要终点包括无进展生存期、出现新转移病灶的时间、开始下一次系统治疗的时间、生活质量和毒性。转化终点包括循环肿瘤 DNA 评估和结果的免疫学预测：SABR-SYNC将提供III期数据，评估SABR对同步寡转移患者总生存期的影响。转化部分将尝试确定新的预后和预测生物标志物，以帮助临床决策：试验注册：Clinicaltrials.gov NCT05717166（注册日期：2023年2月8日）。
期刊介绍：
BMC Palliative Care is an open access journal publishing original peer-reviewed research articles in the clinical, scientific, ethical and policy issues, local and international, regarding all aspects of hospice and palliative care for the dying and for those with profound suffering related to chronic illness.
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