title: Role of geriatric intervention in the treatment of older patients with cancer: rationale and design of a phase III multicenter trial.
abstract: In the general geriatric population, programs linking geriatric evaluation with interventions are effective for improving functional status and survival of the patients. Whether or not these interventions improve health related quality of life (HRQoL) or overall survival (OS) in older patients with cancer is not yet clear. Indeed, randomized data on the effect of such interventions on survival and HRQoL are rare and conflicting. We describe the rationale and design of a phase III multicenter trial aimed at assessing the efficacy of geriatric intervention in the management of elderly patients with cancer.
  
  
  
  Approximately 1200 patients, 70 years and older, considered in need of a geriatric intervention based on the G8 screening tool will be randomized into two intervention arms. The 'Usual-care' arm involves standard oncological care based on pre-defined oncological protocols. In addition to the standard oncological care, the 'Case-management' arm involves a multidimensional geriatric assessment and interventions tailored for the patient. Efficacy will be assessed using a co-primary endpoint encompassing OS and HRQoL.
  
  
  
  This trial has been designed to assess whether focused geriatric case management can either improve OS or HRQoL in elderly cancer patients considered in need of geriatric assessment.
  
  
  
  Clinicaltrials.gov ID: NCT02704832 .
authors.affiliation: Department of Medical Oncology, Institut Bergonié, Comprehensive Cancer Center, F-33000, Bordeaux, France. p.Soubeyran@bordeaux.unicancer.fr.|University of Bordeaux, F-33000, Bordeaux, France. p.Soubeyran@bordeaux.unicancer.fr.|French National Cancer Institute (INCa) Integrated Cancer Research Site (SIRIC), Institut Bergonié, Comprehensive Cancer Center, F-33000, Bordeaux, France. p.Soubeyran@bordeaux.unicancer.fr.|Medical Oncology, Institut Bergonié, Comprehensive Cancer Center, 229 cours de l'Argonne, 33076, Bordeaux, France. p.Soubeyran@bordeaux.unicancer.fr.
authors.forename: Pierre
authors.initials: P
authors.lastname: Soubeyran
authors.affiliation: Department of Medical Oncology, Centre Léon Bérard, Regional Comprehensive Cancer Center, Claude-Bernard Lyon-1 University, Lyon, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Terret
authors.affiliation: Clinical and Epidemiological Research Unit, Institut Bergonié, Comprehensive Cancer Center, F-33000, Bordeaux, France.|Inserm, CIC-EC14.01 (Clinical Investigation Centre - Clinical Epidemiology Unit), F-33000, Bordeaux, France.|Inserm U1219 Research Centre, Epicene Team (Epidemiology of Cancer and Environmental Exposure) University of Bordeaux, Bordeaux, 33076, France.
authors.forename: Carine
authors.initials: C
authors.lastname: Bellera
authors.affiliation: Methodology and Quality of life in Oncology Unit, EA3181. CHU Besançon, F-25000, Besançon, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
authors.affiliation: Geriatric service, Georges Pompidou European Hospital, Paris, France.
authors.forename: Olivier Saint
authors.initials: OS
authors.lastname: Jean
authors.affiliation: French National Cancer Institute (INCa) Integrated Cancer Research Site (SIRIC), Institut Bergonié, Comprehensive Cancer Center, F-33000, Bordeaux, France.|Inserm, CIC-EC14.01 (Clinical Investigation Centre - Clinical Epidemiology Unit), F-33000, Bordeaux, France.
authors.forename: Angéline
authors.initials: A
authors.lastname: Galvin
authors.affiliation: Department of Medical Oncology, Institut Bergonié, Comprehensive Cancer Center, F-33000, Bordeaux, France.|French National Cancer Institute (INCa) Integrated Cancer Research Site (SIRIC), Institut Bergonié, Comprehensive Cancer Center, F-33000, Bordeaux, France.
authors.forename: Camille
authors.initials: C
authors.lastname: Chakiba
authors.affiliation: Department of Medical Oncology, Institut Bergonié, Comprehensive Cancer Center, F-33000, Bordeaux, France.
authors.forename: Marie-Dominique
authors.initials: MD
authors.lastname: Zwolakowski
authors.affiliation: University of Bordeaux, F-33000, Bordeaux, France.|Clinical and Epidemiological Research Unit, Institut Bergonié, Comprehensive Cancer Center, F-33000, Bordeaux, France.|Inserm, CIC-EC14.01 (Clinical Investigation Centre - Clinical Epidemiology Unit), F-33000, Bordeaux, France.|Inserm U1219 Research Centre, Epicene Team (Epidemiology of Cancer and Environmental Exposure) University of Bordeaux, Bordeaux, 33076, France.
authors.forename: Simone
authors.initials: S
authors.lastname: Mathoulin-Pélissier
authors.affiliation: University of Bordeaux, F-33000, Bordeaux, France.|French National Cancer Institute (INCa) Integrated Cancer Research Site (SIRIC), Institut Bergonié, Comprehensive Cancer Center, F-33000, Bordeaux, France.|Inserm U1219 Research Centre, Epicene Team (Epidemiology of Cancer and Environmental Exposure) University of Bordeaux, Bordeaux, 33076, France.|Department of Gerontology, Centre Hospitalier Universitaire, Bordeaux, France.
authors.forename: Muriel
authors.initials: M
authors.lastname: Rainfray
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002985:Clinical Protocols; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D012107:Research Design
keywords: Aged; Cancer; Case-management; Chemotherapy; Clinical trial; Elderly; Geriatric intervention