title: Impact of central surgical review in a study of malignant germ cell tumors.
abstract: BACKGROUND
  Verification of surgical staging has received little attention in clinical oncology trials. Central surgical review was undertaken during a study of malignant pediatric germ cell tumors.
  
  
  METHODS
  Children's Oncology Group study AGCT0132 included central surgical review during the study. Completeness of submitted data and confirmation of assigned stage were assessed. Review responses were: assigned status confirmed, assignment withheld pending review of additional information requested, or institutional assignment of stage disputed with explanation given. Changes in stage assignment were at the discretion of the enrolling institution.
  
  
  RESULTS
  A total of 206 patients underwent central review. Failure to submit required data elements or need for clarification was noted in 40%. Disagreement with stage assignment occurred in 10% with 17/21 discordant patients reassigned to stage recommended by central review. Four ovarian tumor patients not meeting review criteria for Stage I remained in that stratum by institutional decision. Two-year event free survival in Stage I ovarian patients was 25% for discordant patients compared to 57% for those meeting Stage I criteria by central review.
  
  
  CONCLUSIONS
  Central review of stage assignment improved complete data collection and assignment of correct tumor stage at study entry, and allowed for prompt initiation of chemotherapy in patients determined not to have Stage I disease.
authors.affiliation: Department of Surgery, Indiana University School of Medicine, Riley Hospital for Children, Indianapolis, IN, United States. Electronic address: dbillmir@iupui.edu.
authors.forename: Deborah F
authors.initials: DF
authors.lastname: Billmire
authors.affiliation: Department of Surgery, Indiana University School of Medicine, Riley Hospital for Children, Indianapolis, IN, United States.
authors.forename: Frederick J
authors.initials: FJ
authors.lastname: Rescorla
authors.affiliation: Division of Urology, Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, OH, United States.
authors.forename: Jonathan H
authors.initials: JH
authors.lastname: Ross
authors.affiliation: Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, MI, United States.
authors.forename: Marc G
authors.initials: MG
authors.lastname: Schlatter
authors.affiliation: Department of Surgery, University of Alberta, Stollery Childrens Hospital, Edmunton, Alberta, United States.
authors.forename: Bryan J
authors.initials: BJ
authors.lastname: Dicken
authors.affiliation: Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.
authors.forename: Mark D
authors.initials: MD
authors.lastname: Krailo
authors.affiliation: Dana-Farber Cancer Institute, Boston Childrens Hospital, Boston, MA, United States.
authors.forename: Carlos
authors.initials: C
authors.lastname: Rodriguez-Galindo
authors.affiliation: Aflac Cancer and Blood Disorders Center, Childrens Healthcare of Atlanta, Emory University School of Medicine, Atlanta, GA, United States.
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Olson
authors.affiliation: Rocky Mountain Hospital for Children, Presbyterian St Luke's Medical, Denver, CO, United States.
authors.forename: John W
authors.initials: JW
authors.lastname: Cullen
authors.affiliation: Dana-Farber Cancer Institute, Boston Childrens Hospital, Boston, MA, United States.
authors.forename: A Lindsay
authors.initials: AL
authors.lastname: Frazier
mesh_terms: D002648:Child; D003625:Data Collection / Q000379:methods*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D009367:Neoplasm Staging; D009373:Neoplasms, Germ Cell and Embryonal / Q000473:pathology* / Q000601:surgery; D010051:Ovarian Neoplasms / Q000473:pathology* / Q000601:surgery; D012189:Retrospective Studies; D013736:Testicular Neoplasms / Q000473:pathology* / Q000601:surgery; D016896:Treatment Outcome
keywords: Malignant germ cell tumors; Surgical clinical trials; Surgical quality