Clinical Trials in Spinal Tumors: A Two-Decade Review.

Abstract: Objective Clinical trials are essential for assessing advancements in spine tumor therapeutics. The purpose of this study is to characterize trends in clinical trials for primary and metastatic tumor treatments over the past two decades. Methods ClinicalTrials.gov was queried using the search term “spine” for all interventional studies spanning 1999 to 2020 with categories of “Cancer”, “Neoplasm”, “Tumor”, or “Metastasis”. Tumor type, phase data, enrollment numbers and home institution country were recorded. The sponsor was categorized as academic institution, industry, government or other and intervention type as procedure, drug, device, radiation or other. Frequency of each category and cumulative frequency over twenty years were calculated. Results 106 registered trials for spine tumors were listed. All except two that began before 2008 have been completed, enrollment of 51-100 subjects (29.8%) was the most common, and the majority were phase II (54.4%). Most examined metastatic tumors (58.5%) and new trials per year increased 3.4-fold between 2009 and 2020. The majority were conducted in the United States (56.4%). The most common intervention strategy was radiation (32.1%), although between 2010-2020 procedural studies became the most frequent (2.4 per year). The majority were sponsored by academic institutions (63.2%), and over twenty years have sponsored 3.2-fold more studies than industry partners. Conclusions The number of clinical trials for spine tumor therapies has rapidly increased over the past 15 years, driven by studies at United States academic medical institutions investigating radiosurgery for treatment of metastases. Targeted therapies for tumor subtypes and sequelae have updated international best practices.