Randomized Phase II Trial of High-Dose Melatonin and Radiation Therapy for RPA Class 2 Patients With Brain Metastases (RTOG 0119)

Lawrence Berk, Brian Berkey, Tyvin Rich, William Hrushesky, David Blask, Michael Gallagher, Mahesh Kudrimoti, Ronald C. McGarry, John Suh, Minesh Mehta

Research output: Contribution to journalArticlepeer-review

51 Scopus citations


Purpose: 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 and Materials: 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.

Original languageEnglish
Pages (from-to)852-857
Number of pages6
JournalInternational Journal of Radiation Oncology Biology Physics
Issue number3
StatePublished - Jul 1 2007


  • Brain metastases
  • Chronobiology
  • Melatonin
  • Randomized trial
  • Survival

ASJC Scopus subject areas

  • Radiation
  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research


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