A multicenter, randomized, double-blind, placebo-controlled phase III study of monosialoganglioside (GM1) preventing neurotoxicity induced by cisplatin-based chemotherapy in non-small cell lung cancer patients.

Authors

null

Li Zhang

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

Organizations

Sun Yat-sen University Cancer Center, Guangzhou, China, Sun Yat-Sen University Cancer Center, Guangzhou, China, Cancer Center, Sun Yat-Sen University, Guangzhou, China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China, Hospital of Traditional Chinese Medicine of Zhongshan, Zhongshan, China, China State Key Laboratory of Respiratory Disease and Guangzhou Institute of Respiratory Disease; The First Affiliated Hospital of Guangzhou Medical Universit, Guangzhou, China, The Fifth Affiliated Hospital, Sun Yat-Sen University, Zhuhai, China, State Key Laboratory of Oncology in South China, Caner Center, Sun Yat-sen University, Guangzhou, China, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China

Research Funding

Pharmaceutical/Biotech Company

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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Abstract Details

Meeting

2016 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Patient and Survivor Care

Track

Patient and Survivor Care

Sub Track

Palliative Care and Symptom Management

Clinical Trial Registration Number

NCT01882621

Citation

J Clin Oncol 34, 2016 (suppl; abstr TPS10142)

DOI

10.1200/JCO.2016.34.15_suppl.TPS10142

Abstract #

TPS10142

Poster Bd #

129a

Abstract Disclosures