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EpiBrainRad: an epidemiologic study of the neurotoxicity induced by radiotherapy in high grade glioma patients
Authors:Thomas?Durand  Sophie?Jacob  Laura?Lebouil  Hassen?Douzane  Philippe?Lestaevel  Amithys?Rahimian  Dimitri?Psimaras  Lo?c?Feuvret  Delphine?Leclercq  Bruno?Brochet  Radia?Tamarat  Fabien?Milliat  Marc?Benderitter  Nicolas?Vayatis  Georges?No?l  Khê?Hoang-Xuan  Jean-Yves?Delattre  Damien?Ricard  Email author" target="_blank">Marie-Odile?BernierEmail author
Institution:1.UMR CNRS 8257 SSA MD4 Cognition and Action Group,Paris CEDEX 06,France;2.Service de neurologie Mazarin, h?pital de la Pitié-Salpêtrière,Paris,France;3.Institut de Radioprotection et de S?reté Nucléaire (IRSN), PRP-HOM, SRBE,Fontenay aux Roses,France;4.Institut du Cerveau et de la Moelle,Paris,France;5.Unité de neuroradiologie diagnostique et fonctionnelle, h?pital de la Pitié-Salpêtrière,Paris,France;6.Service de Neurologie, groupe h?spitalier Pellegrin,Bordeaux,France;7.UMR CNRS 8536 Centre de mathématiques et de leurs applications, ENS Cachan,Cachan CEDEX,France;8.Département de radiothérapie, centre de lutte contre le cancer Paul Strauss,Strasbourg CEDEX,France;9.Service de neurologie, h?pital d’instruction des armées du Val-de-Grace,Paris,France
Abstract:

Background

Radiotherapy is one of the most important treatments of primary and metastatic brain tumors. Unfortunately, it can involve moderate to severe complications among which leukoencephalopathy is very frequent and implies cognitive deficits such as memory, attention and executive dysfunctions. However, the incidence of this complication is not well established and the risk factors and process are poorly understood. The main objective of the study is to improve knowledge on radio-induced leukoencephalopathy based on pluridisciplinar approaches combining cognitive, biologic, imagery and dosimetric investigations.

Method/Design

The EpiBrainRad study is a prospective cohort study including newly diagnosed high grade gliomas patients treated by radiotherapy and concomitant-adjuvant temozolomide chemotherapy. Patients are included between their surgery and first day of radio-chemotherapy, and the follow-up lasts for 3 years after treatment. Cognitive functioning assessments, specific blood biomarkers measures and magnetic resonance imagery are performed at different moment during the follow-up, and a specific dosimetric assessment of organs involved in the beam fields is performed. Firstly, leukoencephalopathy incidence rate will be estimated in this population. Secondly, correlations between cognitive impairments and dosimetry, biomarkers ranges and anomalies on imagery will be analyzed in order to better understand the onset and evolution of cognitive decrement associated with radiotherapy. Furthermore, a new cognitive test, quickly and easily performed, will be studied to determine its sensibility to detect leukoencephalopathy decrement.

Discussion

With an original multidisciplinary approach, the EpiBrainRad study aims to improve knowledge on radio-induced leukoencephalopathy in order to improve its early diagnosis and prevention. The main challenge is to preserve quality-of-life after cancer treatments which imply to study the incidence of radiation-induced complications and their associated risk factors.

Trial Registration

NCT02544178
Keywords:
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