Berk Lawrence, Berkey Brian, Rich Tyvin, Hrushesky William, Blask David, Gallagher Michael, Kudrimoti Mahesh, McGarry Ronald C, Suh John, Mehta Minesh
Department of Radiation Oncology, H. Lee Moffitt Cancer Center, University of South Florida, Tampa, FL, USA.
Int J Radiat Oncol Biol Phys. 2007 Jul 1;68(3):852-7. doi: 10.1016/j.ijrobp.2007.01.012. Epub 2007 Apr 6.
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.
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.
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.
High-dose melatonin did not show any beneficial effect in this group of patients.
确定对于放射治疗肿瘤学组（RTOG）递归分区分析（RPA）2类脑转移患者，高剂量褪黑素是否能比历史对照改善生存情况，并确定给予褪黑素的时间是否会影响其毒性或疗效。RTOG 0119是针对这类患者的一项II期随机试验。
RTOG RPA 2类脑转移患者被随机分为两组，分别给予20毫克褪黑素，一组在上午（上午8 - 9点）服用，另一组在晚上（晚上8 - 9点）服用。所有患者均在下午接受放射治疗（10次分割，共30 Gy）。褪黑素持续服用直至神经功能恶化或死亡。主要终点是总生存时间。同时也测量了简易精神状态检查所反映的神经功能恶化情况。
两个随机分组的生存分布与接受全脑放疗的历史对照患者相比均无显著差异。上午和晚上服用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历史对照的生存期为4.1个月。
高剂量褪黑素在这类患者中未显示出任何有益效果。
