title: Assessment of quality of life in phase III trials of radiotherapy in localized or locally advanced head and neck cancer over the past 17 years.
abstract: BACKGROUND
  We investigated the extent to which health-related quality of life (HRQOL) parameters have been used as endpoints in recent phase III trials on radiotherapy for head and neck cancer, as well as the frequency and correlates of significant HRQOL gains.
  
  
  METHODS
  Using the medical subject headings "head and neck neoplasms" and "radiotherapy", we searched PubMed for the main paper reporting phase III trials published between 1/1999 and 12/2015 in 16 leading journals.
  
  
  RESULTS
  We found 88 trials that fulfilled the selection criteria (32,707 patients/191 trial arms). HRQOL was listed as an endpoint in 21.3% of trials. HRQOL comparisons between groups were reported in only 12 trials, with statistically significant differences between HRQOL parameters in only three studies, two of which favored the experimental arm.
  
  
  CONCLUSIONS
  HRQOL has been infrequently investigated in phase III trials of radiotherapy in head and neck cancer, typically with no significant differences found between groups.
authors.affiliation: Department of Radiation Oncology, Instituto do Câncer de Estado de São Paulo (ICESP), Faculdade de Medicina da Universidade de São Paulo (FMUSP) and Hospital Sírio-Libanês, Sao Paulo, Brazil. gnmarta@uol.com.br.
authors.forename: Gustavo Nader
authors.initials: GN
authors.lastname: Marta
authors.affiliation: Dendrix Research, Sao Paulo, Brazil.
authors.forename: Everardo D
authors.initials: ED
authors.lastname: Saad
mesh_terms: D017326:Clinical Trials, Phase III as Topic; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006304:Health Status; D006801:Humans; D017063:Outcome Assessment, Health Care; D011788:Quality of Life
keywords: Disease-free survival; head and neck neoplasms; quality of life (QOL); radiotherapy; survival analysis