Palliative Radiotherapy and Oligometastasis Program, Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
Palliative Radiotherapy and Oligometastasis Program, Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.; Department of Radiation Oncology, King Hussein Cancer Center, Amman, Jordan.
Semin Radiat Oncol. 2023 Oct;33(4):416-428. doi: 10.1016/j.semradonc.2023.07.001.
The paradigm of oligometastatic disease (OMD), characterized by a limited number of metastases potentially amenable to local therapies, presents unique opportunities and challenges in clinical trial design and implementation. Although local ablative therapies, such as stereotactic body radiation therapy, have shown promise in improving outcomes for patients with OMD, there is a lack of large-scale randomized phase III trials supporting their widespread use. This paper outlines the key challenges in trial design and implementation in the oligometastatic setting, including appropriate patient selection, the definition of the oligometastatic state, trial design considerations, endpoint selection, and logistical considerations related to enrollment and follow-up. We suggest potential strategies to address these challenges, emphasizing the importance of a comprehensive, patient-centric approach, and the integration of multidisciplinary teams in trial design and implementation. The aim is to encourage the design of well-structured clinical trials, ultimately refining best practices and enhancing patient outcomes in the management of OMD.
寡转移疾病（OMD）的模式，其特征是存在数量有限的、可能适合局部治疗的转移灶，这在临床试验设计和实施中带来了独特的机遇和挑战。尽管局部消融疗法，如立体定向体部放射治疗，已显示出改善寡转移疾病患者预后的潜力，但缺乏支持广泛应用的大规模随机 III 期试验。本文概述了寡转移环境中试验设计和实施的关键挑战，包括适当的患者选择、寡转移状态的定义、试验设计考虑因素、终点选择以及与入组和随访相关的后勤考虑。我们提出了潜在的策略来应对这些挑战，强调了综合、以患者为中心的方法的重要性，以及多学科团队在试验设计和实施中的整合。目的是鼓励设计结构良好的临床试验，最终完善寡转移疾病管理的最佳实践并提高患者的预后。
