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

ABSTRACT

OBJECTIVE: Clinical trials are essential for assessing the advancements in spine tumor therapeutics. The purpose of the present study was to characterize the trends in clinical trials for primary and metastatic tumor treatment during the past 2 decades. METHODS: The ClinicalTrials.gov database was queried using the search term "spine" for all interventional studies from 1999 to 2020 with the categories of "cancer," "neoplasm," "tumor," and/or "metastasis." The tumor type, phase data, enrollment numbers, and home institution country were recorded. The sponsor was categorized as an academic institution, industry, government, or other and the intervention type as procedure, drug, device, radiation therapy, or other. The frequency of each category and the cumulative frequency during the 20-year period were calculated. RESULTS: A total of 106 registered trials for spine tumors were listed. All, except for 2, that had begun before 2008 had been completed. An enrollment of 51-100 participants (29.8%) was the most common, and most were phase II studies (54.4%). Most of the studies had examined metastatic tumors (58.5%), and the number of new trials annually had increased 3.4-fold from 2009 to 2020. Most of the studies had been conducted in the United States (56.4%). The most common intervention strategy was radiation therapy (32.1%), although from 2010 to 2020, procedural studies had become the most frequent (2.4/year). Most of the studies had been sponsored by academic institutions (63.2%), which during the 20-year period had sponsored 3.2-fold more studies compared with the industry partners. CONCLUSIONS: The number of clinical trials for spine tumor therapies has rapidly increased during the past 15 years, owing to studies at U.S. academic medical institutions investigating radiosurgery for the treatment of metastases. Targeted therapies for tumor subtypes and sequelae have updated international best practices.