title: EpiBrainRad: an epidemiologic study of the neurotoxicity induced by radiotherapy in high grade glioma patients.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT02544178.
authors.affiliation: UMR CNRS 8257 SSA MD4 Cognition and Action Group, 45 rue des Saints Pères, 75270, Paris CEDEX 06, France. durand.thomas@live.fr.|Service de neurologie Mazarin, hôpital de la Pitié-Salpêtrière, 47-83 boulevard de l'Hôpital, 75013, Paris, France. durand.thomas@live.fr.
authors.forename: Thomas
authors.initials: T
authors.lastname: Durand
authors.affiliation: Institut de Radioprotection et de Sûreté Nucléaire (IRSN), PRP-HOM, SRBE, 31 avenue de la Division Leclerc, 92260, Fontenay aux Roses, France. sophie.jacob@irsn.fr.
authors.forename: Sophie
authors.initials: S
authors.lastname: Jacob
authors.affiliation: Service de neurologie Mazarin, hôpital de la Pitié-Salpêtrière, 47-83 boulevard de l'Hôpital, 75013, Paris, France. lebouil.la@hotmail.fr.
authors.forename: Laura
authors.initials: L
authors.lastname: Lebouil
authors.affiliation: Service de neurologie Mazarin, hôpital de la Pitié-Salpêtrière, 47-83 boulevard de l'Hôpital, 75013, Paris, France. douzanehassen@gmail.com.
authors.forename: Hassen
authors.initials: H
authors.lastname: Douzane
authors.affiliation: Institut de Radioprotection et de Sûreté Nucléaire (IRSN), PRP-HOM, SRBE, 31 avenue de la Division Leclerc, 92260, Fontenay aux Roses, France. philippe.lestaevel@irsn.fr.
authors.forename: Philippe
authors.initials: P
authors.lastname: Lestaevel
authors.affiliation: Institut du Cerveau et de la Moelle, 47-83 boulevard de l'Hôpital, 75013, Paris, France. amithys.rahimian@icm-institute.org.
authors.forename: Amithys
authors.initials: A
authors.lastname: Rahimian
authors.affiliation: Service de neurologie Mazarin, hôpital de la Pitié-Salpêtrière, 47-83 boulevard de l'Hôpital, 75013, Paris, France. dimitri.psimaras@psl.aphp.fr.
authors.forename: Dimitri
authors.initials: D
authors.lastname: Psimaras
authors.affiliation: Service de neurologie Mazarin, hôpital de la Pitié-Salpêtrière, 47-83 boulevard de l'Hôpital, 75013, Paris, France. loic.feuvret@psl.aphp.fr.
authors.forename: Loïc
authors.initials: L
authors.lastname: Feuvret
authors.affiliation: Unité de neuroradiologie diagnostique et fonctionnelle, hôpital de la Pitié-Salpêtrière, 47-83 boulevard de l'Hôpital, 75013, Paris, France. delphine.leclercq@psl.aphp.fr.
authors.forename: Delphine
authors.initials: D
authors.lastname: Leclercq
authors.affiliation: Service de Neurologie, groupe hôspitalier Pellegrin, place Amélie Raba-Léon, 33076, Bordeaux, France. bruno.brochet@chu-bordeaux.fr.
authors.forename: Bruno
authors.initials: B
authors.lastname: Brochet
authors.affiliation: Institut de Radioprotection et de Sûreté Nucléaire (IRSN), PRP-HOM, SRBE, 31 avenue de la Division Leclerc, 92260, Fontenay aux Roses, France. radia.tamarat@irsn.fr.
authors.forename: Radia
authors.initials: R
authors.lastname: Tamarat
authors.affiliation: Institut de Radioprotection et de Sûreté Nucléaire (IRSN), PRP-HOM, SRBE, 31 avenue de la Division Leclerc, 92260, Fontenay aux Roses, France. Fabien.milliat@irsn.fr.
authors.forename: Fabien
authors.initials: F
authors.lastname: Milliat
authors.affiliation: Institut de Radioprotection et de Sûreté Nucléaire (IRSN), PRP-HOM, SRBE, 31 avenue de la Division Leclerc, 92260, Fontenay aux Roses, France. marc.benderitter@irns.fr.
authors.forename: Marc
authors.initials: M
authors.lastname: Benderitter
authors.affiliation: UMR CNRS 8536 Centre de mathématiques et de leurs applications, ENS Cachan, 61 avenue du président Wilson, 94235, Cachan CEDEX, France. vayatis@cmla.ens-cachan.fr.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Vayatis
authors.affiliation: Département de radiothérapie, centre de lutte contre le cancer Paul Strauss, 3 rue de la porte de l'hôpital, 67065, Strasbourg CEDEX, France. GNoel@strasbourg.unicancer.fr.
authors.forename: Georges
authors.initials: G
authors.lastname: Noël
authors.affiliation: Service de neurologie Mazarin, hôpital de la Pitié-Salpêtrière, 47-83 boulevard de l'Hôpital, 75013, Paris, France. khe.hoang-xuan@psl.aphp.fr.
authors.forename: Khê
authors.initials: K
authors.lastname: Hoang-Xuan
authors.affiliation: Service de neurologie Mazarin, hôpital de la Pitié-Salpêtrière, 47-83 boulevard de l'Hôpital, 75013, Paris, France. jean-yves.delattre@psl.aphp.fr.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Delattre
authors.affiliation: UMR CNRS 8257 SSA MD4 Cognition and Action Group, 45 rue des Saints Pères, 75270, Paris CEDEX 06, France. damien.ricard@m4x.org.|Service de neurologie Mazarin, hôpital de la Pitié-Salpêtrière, 47-83 boulevard de l'Hôpital, 75013, Paris, France. damien.ricard@m4x.org.|Service de neurologie, hôpital d'instruction des armées du Val-de-Grace, 71 boulevard de Port-Royal, 75005, Paris, France. damien.ricard@m4x.org.
authors.forename: Damien
authors.initials: D
authors.lastname: Ricard
authors.affiliation: Institut de Radioprotection et de Sûreté Nucléaire (IRSN), PRP-HOM, SRBE, 31 avenue de la Division Leclerc, 92260, Fontenay aux Roses, France. marie-odile.bernier@irsn.fr.
authors.forename: Marie-Odile
authors.initials: MO
authors.lastname: Bernier
mesh_terms: D000328:Adult; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use; D001932:Brain Neoplasms / Q000628:therapy*; D017024:Chemotherapy, Adjuvant; D003072:Cognition Disorders / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D003606:Dacarbazine / Q000031:analogs & derivatives / Q000627:therapeutic use; D042241:Early Diagnosis; D005260:Female; D005500:Follow-Up Studies; D005910:Glioma / Q000628:therapy*; D006801:Humans; D056784:Leukoencephalopathies / Q000175:diagnosis* / Q000209:etiology / Q000517:prevention & control; D008297:Male; D011446:Prospective Studies; D011878:Radiotherapy / Q000009:adverse effects*; D000077204:Temozolomide
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide