Abstract
BACKGROUND: To present and analyze the current status of registered clinical trials on particle beam (including proton and carbon ion beam) radiation therapy (PBRT) for head and neck (H&N) malignancies, and to provide insights for future clinical research, we designed the cross-sectional analysis. METHODS: We identified and analyzed all clinical trials of interest registered on ClinicalTrials.gov and PTCOG.ch until March 22, 2020. RESULTS: We identified 57 registered clinical trials related to the use of proton therapy or carbon ion radiation therapy (CIRT) in H&N malignancies. There were 20, 27, and 5 trials focused on CIRT, proton therapy, and both ions, respectively. The eligible trials were registered between 2007 and 2020, mainly focused on adenoid cystic carcinoma (ACC), squamous cell carcinoma (SCC), sinonasal malignancies (SNM), skull base tumors, locally advanced, and recurrent tumors. The nature of 23 (40%) trials were not stated and could not be identified. A total of 25 (44%) registered trials were phase II, including randomized controlled trials (RCTs). There were 14 RCTs (7 phase II, 2 phase II/III, 2 phase III, 1 phase I/II, and 2 phase not applicable), and 25 studies including RCTs were registered before the first enrolment. There were 11 completed clinical trials among the eligible trials, including 7 with published trial-related results. CONCLUSIONS: Less than 10% of the countries with PBRT treatment facilities in operation have initiated clinical trials on H&N cancer. Furthermore, among all registered trials, less than 10% have been completed with results published. More clinical trials, especially high quality trials, are needed for optimizing and standardizing treatment techniques of PBRT for H&N malignancies.