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GM1 for Prevention of Oxaliplatin Induced Neurotoxicity in Colorectal Cancer
NCT02251977Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2014
- Primary completion
- Sep 2017
- Countries
- 1
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- chemotherapy-induced peripheral neuropathy (CIPN)
01
Overview
Phase 3, randomised, double-blind trial in chemotherapy-induced peripheral neuropathy (CIPN) comparing Adjuvant Chemotherapy plus GM1 with Adjuvant Chemotherapy plus placebo (2 arms). Primary endpoint: Rates of grade 2 or more chronic cumulative neurotoxicity at 9 months. Started Sep 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Adjuvant Chemotherapy plus GM1
GM1 (80mg or 120mg/day) + mFOLFOX6 or XELOX
Adjuvant Chemotherapy plus placebo
Placebo + mFOLFOX6 or XELOX
03
Who it enrols
Patients with histologically confirmed stage II or III colorectal adenocarcinoma within 2 months of radical resection, intending to receive 6 months of adjuvant chemotherapy (mFOLFOX6 or XELOX). Excludes patients with prior peripheral nerve system disease or prior use of neurotoxic drugs.
04
Endpoints
Primary
Rates of grade 2 or more chronic cumulative neurotoxicity
Secondary
Rates of chronic cumulative neurotoxicity
Time to grade 2 or more neurotoxicity
Rates of dose reduction or withdrawal due to oxaliplatin induced neurotoxicity
Rates of acute neurotoxicity
Rates and grades of adverse reactions
Rates of 3 year disease free survival
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