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

Semin Radiat Oncol. 2018 Apr;28(2):108-113. doi: 10.1016/j.semradonc.2017.12.002.

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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase III as Topic
  • Disease-Free Survival
  • Endpoint Determination
  • Female
  • Humans
  • Male
  • Neoplasm Staging
  • Organs at Risk / radiation effects
  • Oropharyngeal Neoplasms / pathology
  • Oropharyngeal Neoplasms / radiotherapy*
  • Photons / therapeutic use*
  • Proton Therapy / methods*
  • Quality of Life
  • Radiation Injuries / prevention & control
  • Radiotherapy Dosage
  • Radiotherapy, Intensity-Modulated / methods*
  • Randomized Controlled Trials as Topic*
  • Research Design*
  • Texas