Randomized phase II trial of high-dose melatonin and radiation therapy for RPA class 2 patients with brain metastases (RTOG 0119)
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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DOI：
10.1016/j.ijrobp.2007.01.012
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发表时间：
2007-07-01
影响因子：
7
通讯作者：
Mehta, Minesh
中科院分区：
文献类型：
--
作者：
Berk, Lawrence;Berkey, Brian;Mehta, Minesh
目的：确定高剂量褪黑素对于放射治疗肿瘤组（RTOG）递归分配分析（RPA） 2类脑转移患者是否比历史对照组改善生存，并确定给予褪黑素的时间是否影响其毒性或疗效。RTOG 0119是一项针对这组患者的II期随机试验。方法和材料：RTOG RPA 2级脑转移患者随机接受20 mg的褪黑素治疗，在早上（上午8-9点）或晚上（晚上8-9点）给予。所有患者均于下午接受10次30 Gy的放射治疗。褪黑素持续使用，直到神经恶化或死亡。主要终点是总生存时间。此外，还测量了通过迷你精神状态检查反映的神经系统恶化情况。结果：两个随机分组的生存分布与全脑放疗患者的历史对照均无显著差异。早晚褪黑素治疗的中位生存期分别为3.4个月和2.8个月，而RTOG历史对照生存期为4.1个月。结论：大剂量褪黑素对该组患者没有任何有益作用。(c) 2007爱思唯尔公司
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.