A Phase 3 interventional study of GM1 and placebo in Colorectal Cancer and Chemotherapy-induced Neutropenia, sponsored by Yuhong Li. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-10-07.
Sponsored by Yuhong Li · Phase 3, Interventional, and Prevention
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.
Oxaliplatin is a key agent in the treatment of colorectal cancer. However, peripheral neuropathy markedly limits the use of oxaliplatin. Many drugs have been tried to decrease the development of oxaliplatin induced peripheral neurotoxicity, however, the results remain disappointing. This multi-center, randomized, placebo-controlled trial was performed to assess the efficacy of monosialotetrahexosylganglioside (GM1) for preventing oxaliplatin induced neurotoxicity in colorectal cancer patients who received oxaliplatin-based adjuvant chemotherapy.
5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's enrollment of 196 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
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Patients will receive mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or XELOX (capecitabine and oxaliplatin) for adjuvant chemotherapy. While 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: GM1 · Drug: mFOLFOX6 or XELOX
Patients will receive mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or XELOX (capecitabine and oxaliplatin) for adjuvant chemotherapy. While placebo will be delivered to patients through the day before the initiation of chemotherapy (Day0) to the completion of chemotherapy (Day4).
Drug: placebo · Drug: mFOLFOX6 or XELOX
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.
Also known as: monosialotetrahexosylganglioside
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.
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.
Also known as: Oxalipaltin, Leucovorin, Calcium Folinate, 5-Fluorouracil, Capecitabine
rates of grade 2 or more chronic cumulative neurotoxicity of both arms
measured by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0, with standardized questions regarding neurotoxic symptoms and examples of answers
Time frame: 9 months
rates of chronic cumulative neurotoxicity of both arms
measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20
Time frame: 9 months
time to grade 2 or more neurotoxicity of both arms
Time frame: 9 months
rates of dose reduction or withdrawal due to oxaliplatin induced neurotoxicity of both arms
Time frame: 9 months
rates of acute neurotoxicity of both arms
measured by a numerical analog scale ranging from 0 to 10 that addressed sensitivity touching cold items, discomfort swallowing cold items, throat discomfort, and muscle cramps
Time frame: 6 months
rates and grades of adverse reactions of both arms
Time frame: 6 months
rates of 3 year disease free survival of both arms
Time frame: 3 years
change degrees of the levels of nerve growth factor and other neurotrophic factors of both arms
Time frame: 6 months
genetic polymorphisms of oxaliplatin induced severe and cumulative neurotoxicity
Time frame: 6 months
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Monosialotetrahexosylganglioside
Yuhong Li