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.

寡转移性疾病 (OMD) 的典型特征是可能适合局部治疗的转移灶数量有限，这为临床试验设计和实施带来了独特的机遇和挑战。尽管立体定向放射治疗等局部消融疗法已显示出改善 OMD 患者预后的希望，但缺乏支持其广泛使用的大规模随机 III 期试验。本文概述了寡转移环境中试验设计和实施的主要挑战，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。我们提出了应对这些挑战的潜在策略，强调以患者为中心的全面方法的重要性，以及在试验设计和实施中整合多学科团队的重要性。其目的是鼓励设计结构良好的临床试验，最终完善最佳实践并提高 OMD 管理中的患者治疗效果。