Advances and Challenges in Trials of Local Therapy for Patients With Oligometastatic or Oligoprogressive Disease

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 wellstructured clinical trials, ultimately refining best practices and enhancing patient outcomes in the management of OMD. 2023 Published by Elsevier Inc.

Automated summary

The paradigm of oligometastatic disease presents unique opportunities and challenges in clinical trial design and implementation. This paper outlines the key challenges and suggests potential strategies to address them, emphasizing the importance of a comprehensive, patient-centric approach and the integration of multidisciplinary teams. The aim is to encourage the design of well-structured clinical trials to enhance patient outcomes.