Effect of GM1 in Prevention of Oxaliplatin Induced Neurotoxicity in Stage II/III Colorectal Cancer

NCT02251977 ↗

Phase 3 Completed 196 enrolled Yuhong Li

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The primary objective of this study is to assess the efficacy of monosialotetrahexosylganglioside (GM1) for preventing oxaliplatin induced neurotoxicity in colorectal cancer patients who received oxaliplatin-based adjuvant chemotherapy.

Timeline

Start: 2014-09
Primary completion: 2017-09-05
Completion: 2017-09-05

Outcome

Missed primary endpoint

paper There were no significant differences between the arms in the rate of NCI-CTCAE grade 2 or worse neurotoxicity (GM1: 33.7% vs placebo: 31.6%; P = .76) PMID 31724334 ↗

Publications

Wang DS, Wang ZQ, Chen G, Peng JW, Wang W, Deng YH, Wang FH, Zhang JW, Liang HL, Feng F, Xie CB, Ren C, Jin Y, Shi SM, Fan WH, Lu ZH, Ding PR, Wang F, Xu RH, Li YH. Phase III randomized, placebo-controlled, double-blind study of monosialotetrahexosylganglioside for the prevention of oxaliplatin-induced peripheral neurotoxicity in stage II/III colorectal cancer. Cancer Med. 2020 Jan;9(1):151-159. doi: 10.1002/cam4.2693. Epub 2019 Nov 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GM1	Unknown	80 mg	Intravenous
Subject	GM1	Unknown	120 mg	Intravenous
Background	Capecitabine	Small molecule	1000 mg/m2	Oral
Background	Leucovorin	Small molecule	200 mg/m2	Intravenous
Background	Leucovorin	Small molecule	400 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	130 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2.4 g	Intravenous