title: Results of a prospective randomized trial comparing standard dose neuraxis irradiation (3,600 cGy/20) with reduced neuraxis irradiation (2,340 cGy/13) in patients with low-stage medulloblastoma. A Combined Children's Cancer Group-Pediatric Oncology Group Study.
abstract: OBJECTIVE
  To determine in a prospective randomized trial the effect on survival, progression-free survival, and patterns of relapse of a decrease in the neuraxis radiation dose from 3,600 cGy in 20 fractions to 2,340 cGy in 13 fractions in patients with newly diagnosed medulloblastoma between 3 and 21 years of age with low T stage (T1, T2 and T3A), minimal postoperative residual tumor, and no evidence of dissemination (M0).
  
  
  METHODS
  Between June 1986 and November 1990, the Children's Cancer Group and the Pediatric Oncology Group randomized 126 patients in a two-arm study comparing the two different doses of neuraxis irradiation. In both arms, the posterior fossa received 5,400 cGy in 30 fractions. All patients were staged with myelography, postoperative lumbar cerebrospinal fluid cytology, and postoperative contrast-enhanced cranial computerized tomography to ensure no evidence of dissemination and no more than 1.5 cm3 residual tumor volume. Overall survival, progression-free survival, and patterns of recurrence were carefully monitored. Prospective endocrine and psychometric studies were performed to determine the benefit of decreasing the neuraxis radiation dose.
  
  
  RESULTS
  Following an interim analysis at a median time on study of 16 months, the study was closed, since a statistically significant increase was observed in the number of all relapses as well as isolated neuraxis relapses in patients randomized to the lower dose of neuraxis radiation.
  
  
  CONCLUSIONS
  In patients with newly diagnosed medulloblastoma considered to have a good prognosis on the basis of low T stage, minimal residual tumor after at least subtotal resection, and no evidence of dissemination after thorough evaluation, there is an increased risk of early relapse associated with lowering the dose of neuraxis radiation from 3,600 cGy in 20 fractions to 2,340 cGy in 13 fractions.
authors.affiliation: University of Pittsburgh Medical Center, Pa., USA.
authors.forename: M
authors.initials: M
authors.lastname: Deutsch
authors.forename: P R
authors.initials: PR
authors.lastname: Thomas
authors.forename: J
authors.initials: J
authors.lastname: Krischer
authors.forename: J M
authors.initials: JM
authors.lastname: Boyett
authors.forename: L
authors.initials: L
authors.lastname: Albright
authors.forename: P
authors.initials: P
authors.lastname: Aronin
authors.forename: J
authors.initials: J
authors.lastname: Langston
authors.forename: J C
authors.initials: JC
authors.lastname: Allen
authors.forename: R J
authors.initials: RJ
authors.lastname: Packer
authors.forename: R
authors.initials: R
authors.lastname: Linggood
authors.forename: R
authors.initials: R
authors.lastname: Mulhern
authors.forename: P
authors.initials: P
authors.lastname: Stanley
authors.forename: J A
authors.initials: JA
authors.lastname: Stehbens
authors.forename: P
authors.initials: P
authors.lastname: Duffner
authors.forename: L
authors.initials: L
authors.lastname: Kun
authors.forename: L
authors.initials: L
authors.lastname: Rorke
authors.forename: J
authors.initials: J
authors.lastname: Cherlow
authors.forename: H
authors.initials: H
authors.lastname: Freidman
authors.forename: J L
authors.initials: JL
authors.lastname: Finlay
authors.forename: T
authors.initials: T
authors.lastname: Vietti
mesh_terms: D000293:Adolescent; D000328:Adult; D001921:Brain / Q000473:pathology / Q000528:radiation effects*; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D003388:Cranial Fossa, Posterior / Q000473:pathology / Q000528:radiation effects*; D006801:Humans; D008527:Medulloblastoma / Q000473:pathology / Q000532:radiotherapy*; D009490:Neurosecretory Systems / Q000502:physiology; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D019292:Skull Base Neoplasms / Q000473:pathology / Q000532:radiotherapy*