title: Trial design on prophylaxis and treatment of brain metastases: lessons learned from the EORTC Brain Metastases Strategic Meeting 2012.
abstract: Brain metastases (BM) occur in a significant proportion of cancer patients and are associated with considerable morbidity and poor prognosis. The trial design in BM patients is particularly challenging, as many disease and patient variables, statistical issues, and the selection of appropriate end-points have to be taken into account. During a meeting organised on behalf of the European Organisation for Research and Treatment of Cancer (EORTC), methodological aspects of trial design in BM were discussed. This paper summarises the issues and potential trial strategies discussed during this meeting and may provide some guidance for the design of trials in BM patients.
authors.affiliation: Department of Medicine I & Comprehensive Cancer Center, Medical University of Vienna, Waehringer Guertel 18-20, Vienna, Austria. matthias.preusser@meduniwien.ac.at
authors.forename: Matthias
authors.initials: M
authors.lastname: Preusser
authors.forename: Frank
authors.initials: F
authors.lastname: Winkler
authors.forename: Laurence
authors.initials: L
authors.lastname: Collette
authors.forename: Sven
authors.initials: S
authors.lastname: Haller
authors.forename: Sandrine
authors.initials: S
authors.lastname: Marreaud
authors.forename: Riccardo
authors.initials: R
authors.lastname: Soffietti
authors.forename: Martin
authors.initials: M
authors.lastname: Klein
authors.forename: Jaap C
authors.initials: JC
authors.lastname: Reijneveld
authors.forename: Jörg-Christian
authors.initials: JC
authors.lastname: Tonn
authors.forename: Brigitta G
authors.initials: BG
authors.lastname: Baumert
authors.forename: Paula
authors.initials: P
authors.lastname: Mulvenna
authors.forename: Dirk
authors.initials: D
authors.lastname: Schadendorf
authors.forename: Renata
authors.initials: R
authors.lastname: Duchnowska
authors.forename: Anna Sophie
authors.initials: AS
authors.lastname: Berghoff
authors.forename: Nancy
authors.initials: N
authors.lastname: Lin
authors.forename: David A
authors.initials: DA
authors.lastname: Cameron
authors.forename: Yazid
authors.initials: Y
authors.lastname: Belkacemi
authors.forename: Jacek
authors.initials: J
authors.lastname: Jassem
authors.forename: Damien C
authors.initials: DC
authors.lastname: Weber
mesh_terms: D015415:Biomarkers; D001932:Brain Neoplasms / Q000401:mortality / Q000517:prevention & control / Q000532:radiotherapy / Q000556:secondary* / Q000628:therapy; D059248:Chemoradiotherapy / Q000009:adverse effects; D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D003072:Cognition Disorders / Q000209:etiology / Q000517:prevention & control / Q000523:psychology; D016371:Cranial Irradiation / Q000009:adverse effects; D023381:Endpoint Determination; D005060:Europe; D006801:Humans; D058990:Molecular Targeted Therapy; D015337:Multicenter Studies as Topic / Q000379:methods*; D059906:Neuroimaging / Q000592:standards; D010166:Palliative Care; D018579:Patient Selection; D011379:Prognosis; D011788:Quality of Life; D012107:Research Design; D057170:Translational Research, Biomedical; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers