Randomized phase II trial of high-dose melatonin and radiation therapy for RPA class 2 patients with brain metastases (RTOG 0119).
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.
Berk
Lawrence
L
Department of Radiation Oncology, H. Lee Moffitt Cancer Center, University of South Florida, Tampa, FL, USA. Berklb@moffitt.ucsf.edu
Berkey
Brian
B
Rich
Tyvin
T
Hrushesky
William
W
Blask
David
D
Gallagher
Michael
M
Kudrimoti
Mahesh
M
McGarry
Ronald C
RC
Suh
John
J
Mehta
Minesh
M
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
D000970:Antineoplastic Agents; D008550:Melatonin