Sun Yat-sen University Cancer Center, Guangzhou, China
Li Zhang , Ting Zhou , Yuxiang Ma , Yunpeng Yang , Wenfeng Fang , Yuangyuan Zhao , Shaodong Hong , Chan Fang , Jiexia Zhang , Hongyu Zhang , Hongyun Zhao , Yan Huang
Background: The peripheral neurotoxicity induced by cisplatin is a common adverse event in non-small cell lung cancer (NSCLC) patients. This phase III trial will evaluate the efficacy and safety of monosialoganlioside (GM1) preventing neurotoxicity induced by chemotherapy contained cisplatin in patients with NSCLC. Methods: The population consists of NSCLC patients that received cispaltin-based doublet chemotherapy as. Eligible patients will be randomized in a 1:1 ratio to receive either GM1 or placebo (80mg on days 0-3, every 3 weeks), concomitant with cisplatin-based chemotherapy (cisplatin 75 mg/m2 on day 1 or on days 1-3, every 3 weeks) for 4 or 6 cycles. The neurotoxicity evaluation will be conducted every cycle and 3w/11w/19w after the cispaltin-based chemotherapy. The primary endpoint is incidence rate of neurotoxicity adverse events. Secondary endpoints include eurotoxicity the safety and quality of life and adverse events alleviation time. According to previously reported, it was assumed that the incidence rate of neurotoxicity would be 50% in the placebo group and 30% in the GM1 group. To detect a 20% reduction in incidence rate of neurotoxicity in GM1 group at a two-sided significant level of 0.05 and power of 0.08, allowing for a drop-out rate of 10%, the sample size was calculated to be 150 patients per group. 300 patients will be enrolled in the trial at 10 sites in China. So far, 200 patients have been enrolled. Clinical trial information: NCT01882621
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