Authors: | Frank, S. J.; Blanchard, P.; Lee, J. J.; Sturgis, E. M.; Kies, M. S.; Machtay, M.; Vikram, B.; Garden, A. S.; Rosenthal, D. I.; Gunn, G. B.; Fuller, C. D.; Hutcheson, K.; Lai, S.; Busse, P. M.; Lee, N. Y.; Lin, A.; Foote, R. L. |
Article Title: | Comparing intensity-modulated proton therapy with intensity-modulated photon therapy for oropharyngeal cancer: The journey from clinical trial concept to activation |
Abstract: | Intensity-modulated proton therapy minimizes the incidental irradiation of normal tissues in patients with head and neck cancer relative to intensity-modulated photon (x-ray) therapy and has been associated with lesser treatment-related toxicity and improved quality of life. A phase II/III randomized trial sponsored by the US National Cancer Institute is currently underway to compare deintensification treatment strategies with intensity-modulated proton therapy vs intensity-modulated photon (x-ray) therapy for patients with advanced-stage oropharyngeal tumors. After significant input from numerous stakeholders, the phase III portion of the randomized trial was redesigned as a noninferiority trial with progression-free survival as the primary endpoint. The process by which that redesign took place is described here. © 2018 The Authors |
Journal Title: | Seminars in Radiation Oncology |
Volume: | 28 |
Issue: | 2 |
ISSN: | 1053-4296 |
Publisher: | Elsevier Inc. |
Date Published: | 2018-04-01 |
Start Page: | 108 |
End Page: | 113 |
Language: | English |
DOI: | 10.1016/j.semradonc.2017.12.002 |
PROVIDER: | scopus |
PMCID: | PMC5942581 |
PUBMED: | 29735186 |
DOI/URL: | |
Notes: | Review -- Export Date: 1 June 2018 -- Source: Scopus |