Randomized Phase II Trial of High-Dose Melatonin and Radiation Therapy for RPA Class 2 Patients With Brain Metastases (RTOG 0119)
- Department of Radiation Oncology, H. Lee Moffitt Cancer Center, University of South Florida, Tampa, FL (United States)
- Department of Statistics, Radiation Therapy Oncology Group, Philadelphia, PA (United States)
- Department of Radiation Oncology, University of Virginia, Charlottesville, VA (United States)
- Laboratory of Experimental Neuroendocrinology/Oncology, W. J. B. Dorn Veterans Administration Medical Center, University of South Carolina Arnold School of Public Health and University of South Carolina School of Medicine, Columbia, SC (United States)
- Medical Chronobiology Laboratory, S. C. Bassett Research Institute, Cooperstown, NY (United States)
- Scranton Radiation Medicine Association, Scranton, PA (United States)
- Department of Radiation Oncology, University of Kentucky, Lexington, KY (United States)
- Department of Radiation Oncology, Indiana University, Indianapolis, IN (United States)
- Department of Radiation Oncology, Cleveland Clinic, Cleveland, OH (United States)
- Department of Radiation Oncology, University of Wisconsin, Madison, WI (United States)
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.
- OSTI ID:
- 20951715
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 68, Issue 3; Other Information: DOI: 10.1016/j.ijrobp.2007.01.012; PII: S0360-3016(07)00114-9; Copyright (c) 2007 Elsevier Science B.V., Amsterdam, Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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