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

PHASE3CompletedINTERVENTIONAL
Enrollment

196

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

September 5, 2017

Study Completion Date

September 5, 2017

Conditions
Colorectal CancerChemotherapy-induced Neutropenia
Interventions
DRUG

GM1

GM1 will be delivered to patients through the day before the initiation of chemotherapy (Day0) to the completion of chemotherapy (Day4), and the dosages of GM1 for patients who receive mFOLFOX6 or XELOX are 80mg or 120mg per day.

DRUG

placebo

Placebo will be delivered to patients through the day before the initiation of chemotherapy (Day0) to the completion of chemotherapy (Day4), and the dosages of placebo for patients who receive mFOLFOX6 or XELOX are 80mg or 120mg per day.

DRUG

mFOLFOX6 or XELOX

"mFOLFOX6: Patients will receive mFOLFOX6 every 14 days, Oxaliplatin 85mg/m2 IV over 3 hours on Day1; Calcium Folinate IV over 2h on Day 1(Leucovorin 200mg/m2 or CF 400 mg/m2); 5-Fluorouracil 400mg/m2 IV on Day1; followed by 5-Fluorouracil 2.4g/m2 for 46 hours continuous infusion on Day1.~XELOX: Patients will receive XELOX every 21 days, Oxaliplatin 130mg/m2 IV over 3 hours on Day1;followed by Capecitabine 1000mg/m2 oral twice daily for 14 days.~The optimum chemotherapy regimen is at the discretion of the investigators based on the condition of each patient."

Trial Locations (1)

510060

Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Yuhong Li

OTHER

NCT02251977 - Effect of GM1 in Prevention of Oxaliplatin Induced Neurotoxicity in Stage II/III Colorectal Cancer | Biotech Hunter | Biotech Hunter