drugset / Trial / NCT02024412

Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in mCRC

NCT02024412 ↗

Non-randomizedParallel-groupDouble-blindPrevention

Summary

The morbidity of colorectal cancer(CRC) is 10%~15% in China.mFolfox6 has become one of the standard regimes for metastatic colorectal cancer (mCRC). Neutropenia and oxaliplatin-induced neurotoxicity are the most common adverse effects which even result in discontinue of chemotherapy, especially for patients suffered from heavily acute neurotoxicity. Monosialotetrahexosylganglioside is a component of membrane of nerve cells. Previous phase II clinical trial showed, it can reduce oxaliplatin-induced neurotoxicity(OIN). But it did not certificated by phase III trial. Investigators designed the phase III trial to investigate the effect and safety of monosialotetrahexosylganglioside Sodium Injection for prevention OIN at colorectal cancer.

Timeline

Start
2013-11
Primary completion
2016-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject monosialotetrahexosylganglioside Sodium Unknown 40 mg —

Indications