Role of geriatric intervention in the treatment of older patients with cancer: rationale and design of a phase III multicenter trial

BMC Cancer

Study Protocol

Carine Bellera¹  Catherine Terret²  Marie-Dominique Zwolakowski³  Camille Chakiba⁴  Pierre Soubeyran⁵  Angéline Galvin⁶  Olivier Saint Jean⁷  Franck Bonnetain⁸  Simone Mathoulin-Pélissier⁹  Muriel Rainfray^1,10 

[1] 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, 33076, Bordeaux, France;Department of Medical Oncology, Centre Léon Bérard, Regional Comprehensive Cancer Center, Claude-Bernard Lyon-1 University, Lyon, France;Department of Medical Oncology, Institut Bergonié, Comprehensive Cancer Center, F-33000, Bordeaux, France;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;Department of Medical Oncology, Institut Bergonié, Comprehensive Cancer Center, F-33000, Bordeaux, France;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;Medical Oncology, Institut Bergonié, Comprehensive Cancer Center, 229 cours de l’Argonne, 33076, Bordeaux, France;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;Geriatric service, Georges Pompidou European Hospital, Paris, France;Methodology and Quality of life in Oncology Unit, EA3181. CHU Besançon, F-25000, Besançon, France;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, 33076, Bordeaux, France;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, 33076, Bordeaux, France;Department of Gerontology, Centre Hospitalier Universitaire, Bordeaux, France;

关键词: Aged;    Elderly;    Cancer;    Geriatric intervention;    Case-management;    Chemotherapy;    Clinical trial;   

DOI  :  10.1186/s12885-016-2927-4

 received in 2016-01-18, accepted in 2016-11-06,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundIn 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.Methods/designApproximately 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.DiscussionThis 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.Trial registrationClinicaltrials.gov ID: NCT02704832.

【 授权许可】

CC BY   
© The Author(s). 2016