title: Randomized phase II trial of high-dose melatonin and radiation therapy for RPA class 2 patients with brain metastases (RTOG 0119).
abstract: OBJECTIVE
  To determine if high-dose melatonin for Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) Class 2 patients with brain metastases improved survival over historical controls, and to determine if the time of day melatonin was given affected its toxicity or efficacy. RTOG 0119 was a phase II randomized trial for this group of patients.
  
  
  METHODS
  RTOG RPA Class 2 patients with brain metastases were randomized to 20 mg of melatonin, given either in the morning (8-9 AM) or in the evening (8-9 PM). All patients received radiation therapy (30 Gy in 10 fractions) in the afternoon. Melatonin was continued until neurologic deterioration or death. The primary endpoint was overall survival time. Neurologic deterioration, as reflected by the Mini-Mental Status Examination, was also measured.
  
  
  RESULTS
  Neither of the randomized groups had survival distributions that differed significantly from the historic controls of patients treated with whole-brain radiotherapy. The median survivals of the morning and evening melatonin treatments were 3.4 and 2.8 months, while the RTOG historical control survival was 4.1 months.
  
  
  CONCLUSIONS
  High-dose melatonin did not show any beneficial effect in this group of patients.
authors.affiliation: Department of Radiation Oncology, H. Lee Moffitt Cancer Center, University of South Florida, Tampa, FL, USA. Berklb@moffitt.ucsf.edu
authors.forename: Lawrence
authors.initials: L
authors.lastname: Berk
authors.forename: Brian
authors.initials: B
authors.lastname: Berkey
authors.forename: Tyvin
authors.initials: T
authors.lastname: Rich
authors.forename: William
authors.initials: W
authors.lastname: Hrushesky
authors.forename: David
authors.initials: D
authors.lastname: Blask
authors.forename: Michael
authors.initials: M
authors.lastname: Gallagher
authors.forename: Mahesh
authors.initials: M
authors.lastname: Kudrimoti
authors.forename: Ronald C
authors.initials: RC
authors.lastname: McGarry
authors.forename: John
authors.initials: J
authors.lastname: Suh
authors.forename: Minesh
authors.initials: M
authors.lastname: Mehta
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage; D001932:Brain Neoplasms / Q000401:mortality / Q000532:radiotherapy* / Q000556:secondary*; D005260:Female; D006801:Humans; D008550:Melatonin / Q000008:administration & dosage*; D008875:Middle Aged; D015995:Prevalence; D018714:Radiotherapy, Adjuvant / Q000401:mortality*; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome; D014481:United States
chemical_list: D000970:Antineoplastic Agents; D008550:Melatonin