| Literature DB >> 29735186 |
Steven J Frank1, Pierre Blanchard2, J Jack Lee3, Erich M Sturgis4, Merrill S Kies5, Mitchell Machtay6, Bhadrasain Vikram7, Adam S Garden8, David I Rosenthal8, G Brandon Gunn8, C David Fuller8, Katherine Hutcheson4, Stephen Lai4, Paul M Busse9, Nancy Y Lee10, Alexander Lin11, Robert L Foote12.
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.Entities:
Mesh:
Year: 2018 PMID: 29735186 PMCID: PMC5942581 DOI: 10.1016/j.semradonc.2017.12.002
Source DB: PubMed Journal: Semin Radiat Oncol ISSN: 1053-4296 Impact factor: 5.934