Journal
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS
Volume 68, Issue 3, Pages 852-857Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.ijrobp.2007.01.012
Keywords
melatonin; brain metastases; chronobiology; randomized trial; survival
Funding
- NCI NIH HHS [U10 CA32115, U10 CA37422, U10 CA037422, U10 CA021661, U10 CA032115, U10 CA037422-21, U10 CA21661] Funding Source: Medline
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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 inelatonin, 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. (c) 2007 Elsevier Inc.
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