Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8607549 | Seminars in Radiation Oncology | 2018 | 6 Pages |
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.
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Authors
Steven J. MD, Pierre MD, PhD, J. Jack PhD, Erich M. MD, MPH, Merrill S. MD, Mitchell MD, Bhadrasain MD, Adam S. MD, David I. MD, G. Brandon MD, C. David MD, PhD, Katherine PhD, Stephen MD, PhD, Paul M. MD, PhD, Nancy Y. MD, Alexander MD, Robert L. MD,