title: Access to clinical trials for adolescents with soft tissue sarcomas: Enrollment in European pediatric Soft tissue sarcoma Study Group (EpSSG) protocols.
abstract: Adolescents with cancer are enrolled in clinical trials at far lower rates than children. This report compares the number of adolescents (15-19-year-olds) and children (0-14-year-olds) enrolled in the protocols of the European pediatric Soft tissue sarcoma Study Group (EpSSG) with the number of cases expected to occur.
  
  
  
  The observed-to-expected (O/E) ratio was detected in the EpSSG countries contributing most of the cases, that is, Italy, France, Spain, the Netherlands, United Kingdom, and Ireland. The observed cases included patients enrolled in any of the EpSSG protocols from October 2008 to October 2015, when all EpSSG protocols were open in these countries. The number of expected cases was calculated from the incidence rates estimated throughout the RARECAREnet database in the countries' population-based cancer registries.
  
  
  
  In the countries considered, 2,118 cases aged 0-19 years were enrolled in the EpSSG trials from 2008 to 2015: 82.8% were children and 17.2% were adolescents. The O/E ratio was 0.30 among patients 15-19 years old, as opposed to 0.64 for those 0-14 years old. The O/E ratio differed for the different subtypes: in adolescents, it was 0.64 and 0.18 for rhabdomyosarcoma (RMS) and non-rhabdomyosarcoma soft tissue sarcomas (NRSTS), respectively; in children, it was 0.77 and 0.50, respectively. The O/E ratios differed across the countries considered.
  
  
  
  Adolescents were less well represented than children on the EpSSG protocols, with better enrolment for RMS than for NRSTS for all age groups.
authors.affiliation: Pediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Ferrari
authors.affiliation: Department of Preventive and Predictive Medicine, Evaluative Epidemiology Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Trama
authors.affiliation: Clinical Trials and Biostatistics Unit, IRCCS Istituto Oncologico Veneto, Padova, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: De Paoli
authors.affiliation: Department of Pediatric Oncology, Institut d'Hematologie et d'Oncologie Pédiatrique, Centre Léon Bérard, Lyon, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Bergeron
authors.affiliation: Department of Pediatric Oncology, Emma Children's Hospital-Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Johannes H M
authors.initials: JHM
authors.lastname: Merks
authors.affiliation: Department of Pediatric Oncology, Children's Hospital for Wales, Heath Park, Cardiff, United Kingdom.
authors.forename: Meriel
authors.initials: M
authors.lastname: Jenney
authors.affiliation: Department of Pediatric, Adolescent and Young Adult Oncology, Institut Curie, Paris, France.
authors.forename: Daniel
authors.initials: D
authors.lastname: Orbach
authors.affiliation: Department of Paediatric Oncology, Royal Marsden Hospital, London, United Kingdom.
authors.forename: Julia C
authors.initials: JC
authors.lastname: Chisholm
authors.affiliation: Department of Paediatric Oncology, Hospital Universitario Vall d'Hebron, Barcelona, Spain.
authors.forename: Soledad
authors.initials: S
authors.lastname: Gallego
authors.affiliation: Department of Pediatrics, University Hospital Oslo, Rikshospitalet, Oslo, Norway.
authors.forename: Heidi
authors.initials: H
authors.lastname: Glosli
authors.affiliation: Clinical Trials and Biostatistics Unit, IRCCS Istituto Oncologico Veneto, Padova, Italy.
authors.forename: Gian Luca
authors.initials: GL
authors.lastname: De Salvo
authors.affiliation: Department of Preventive and Predictive Medicine, Evaluative Epidemiology Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Botta
authors.affiliation: Department of Preventive and Predictive Medicine, Evaluative Epidemiology Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy.
authors.forename: Gemma
authors.initials: G
authors.lastname: Gatta
authors.affiliation: Pediatric Hematology and Oncology Division, Padova University, Padova, Italy.
authors.forename: Gianni
authors.initials: G
authors.lastname: Bisogno
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D005060:Europe / Q000453:epidemiology; D005260:Female; D006297:Health Services Accessibility; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D012189:Retrospective Studies; D012208:Rhabdomyosarcoma / Q000453:epidemiology* / Q000628:therapy*
keywords: access to care; adolescents; clinical trials; enrollment; pediatric protocols; rhabdomyosarcoma; soft tissue sarcomas