title: Impact of comprehensive geriatric assessment on survival, function, and nutritional status in elderly patients with head and neck cancer: protocol for a multicentre randomised controlled trial (EGeSOR).
abstract: BACKGROUND
  Survival is poorer in elderly patients with head and neck squamous cell carcinomas [HNSCCs] than in younger patients. Possible explanations include a contribution of co-morbidities to mortality, frequent refusal of standard therapy, and the use of suboptimal treatments due to concern about toxicities. The Comprehensive Geriatric Assessment [CGA] is a multidimensional assessment of general health that can help to customise treatment and follow-up plans. The CGA has been proven effective in several health settings but has not been evaluated in randomised studies of patients with cancer. Our aim here was to assess the impact of the CGA on overall survival, function, and nutritional status of elderly patients with HNSCC.
  
  
  METHODS
  EGeSOR is an open-label, multicentre, randomised, controlled, parallel-group trial in patients aged 70 years or older and receiving standard care for HNSCC. The intervention includes four components: the CGA conducted by a geriatrician before cancer treatment, participation of the same geriatrician in cancer treatment selection, a standardised geriatric therapeutic intervention designed by the same geriatrician; and geriatric follow-up for 24 months. The primary endpoint, assessed after 6 months, is a composite criterion including death, functional impairment [Activities of Daily Living score decrease ≥ 2], and weight loss ≥ 10%. Secondary endpoints include progression-free survival, unscheduled admissions, quality of life, treatment toxicities, costs, and completion of the planned cancer treatment. A centralised online system is used to perform 1:1 randomisation with a minimisation algorithm for centre, age, T and N stages, and tumour site [oral, oropharyngeal, hypopharyngeal, or laryngeal]. The estimated sample size is 704 patients, who are being recruited by 14 centres in 9 French cities.
  
  
  CONCLUSIONS
  EGeSOR is the first randomised trial of the CGA in elderly cancer patients. We expect the CGA to have direct clinical benefits on the management of elderly patients with HNSCC. If this expectation is fulfilled, the trial may lead to modifications of the management model for elderly patients with cancer.
  
  
  BACKGROUND
  Trial registration: NCT02025062.
authors.forename: Lydia
authors.initials: L
authors.lastname: Brugel
authors.forename: Marie
authors.initials: M
authors.lastname: Laurent
authors.forename: Philippe
authors.initials: P
authors.lastname: Caillet
authors.forename: Anne
authors.initials: A
authors.lastname: Radenne
authors.forename: Isabelle
authors.initials: I
authors.lastname: Durand-Zaleski
authors.forename: Michel
authors.initials: M
authors.lastname: Martin
authors.forename: Melany
authors.initials: M
authors.lastname: Baron
authors.forename: Héloïse
authors.initials: H
authors.lastname: de Kermadec
authors.forename: Sylvie
authors.initials: S
authors.lastname: Bastuji-Garin
authors.forename: Florence
authors.initials: F
authors.lastname: Canouï-Poitrine
authors.affiliation: AP-HP, hôpital Henri-Mondor, Département de Médecine Interne et Gériatrie, Unité d'Onco-Gériatrie, Créteil F-94010, France. elena.paillaud@hmn.aphp.fr.
authors.forename: Elena
authors.initials: E
authors.lastname: Paillaud
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002985:Clinical Protocols; D015577:Geriatric Assessment; D006258:Head and Neck Neoplasms / Q000453:epidemiology*; D006801:Humans; D009026:Mortality; D009752:Nutritional Status