Randomized phase II trial of high-dose melatonin and radiation therapy for RPA class 2 patients with brain metastases (RTOG 0119

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Int J Radiat Oncol Biol Phys. 2007 Jul 1;68(3):852-7. Epub 2007 Apil 6

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Randomized
phase II trial of high-dose melatonin and radiation therapy for RPA
class 2 patients with brain metastases (RTOG 0119).
Berk L, Berkey B, Rich T, Hrushesky W, Blask D, Gallagher M, Kudrimoti M, McGarry RC, Suh J, Mehta M.

Department
of Radiation Oncology, H. Lee Moffitt Cancer Center, University of
South Florida, Tampa, FL, USA.

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.