Comparing Intensity-Modulated Proton Therapy With Intensity-Modulated Photon Therapy for Oropharyngeal Cancer: The Journey From Clinical Trial Concept to Activation

Steven J. Frank, Pierre Blanchard, J. Jack Lee, Erich M. Sturgis, Merrill S. Kies, Mitchell Machtay, Bhadrasain Vikram, Adam S. Garden, David I. Rosenthal, G. Brandon Gunn, C. David Fuller, Katherine Hutcheson, Stephen Lai, Paul M. Busse, Nancy Y. Lee, Alexander Lin, Robert L. Foote

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    Résumé

    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.

    langue originaleAnglais
    Pages (de - à)108-113
    Nombre de pages6
    journalSeminars in Radiation Oncology
    Volume28
    Numéro de publication2
    Les DOIs
    étatPublié - 1 avr. 2018

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