The Effect of Monosialotetrahexosylganglioside (GM1) in Prevention of Oxaliplatin Induced Neurotoxicity in Colorectal Cancer Patients Who Received Oxaliplatin-based Adjuvant Chemotherapy: A Multi-center, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- rates of grade 2 or more chronic cumulative neurotoxicity of both arms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old, male or female
- •Histologically confirmed diagnosis of colorectal adenocarcinoma with a phase II or III disease, within 2 months from radical resection, and intends to receive 6 months of adjuvant chemotherapy with mFOLOFX6 or XELOX, without adjuvant radiation indications
- •No prior any level of peripheral nerve system disease
- •Patients have not received any other possible neurotoxic-reaction-causing drugs (such as oxaliplatin, cisplatin and paclitaxel drugs etc)
- •With the capability to accurately record the occurrence and severity of neurotoxicity by questionnaire
- •With normal functions of major organs
- •No contraindication to chemotherapy
- •Life expectancy ≥ 3 months
- •Patients have provided a signed Informed Consent Form
排除标准
- •Patients who received radical resection, but are expected not be able to complete 6 months of adjuvant chemotherapy
- •Patients who receive palliative chemotherapy
- •Patients who need adjuvant or palliative radiotherapy during chemotherapy
- •Be allergic to GM1
- •Hereditary abnormal metabolism of glucose and lipid
- •Doctors believe that patients are not suitable for receiving GM1 treatment
- •With confirmed history of neurological or psychiatric disorders, including epilepsy and dementia
- •With concomitant diseases that will seriously harm the patients' safety or impact the completion of the study
- •Patients (male or female) have fertility possibility but not willing or not to take effective contraceptive measures
研究组 & 干预措施
Adjuvant Chemotherapy plus GM1
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.
干预措施: GM1 (Drug)
Adjuvant Chemotherapy plus GM1
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.
干预措施: mFOLFOX6 or XELOX (Drug)
Adjuvant Chemotherapy plus placebo
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).
干预措施: placebo (Drug)
Adjuvant Chemotherapy plus placebo
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).
干预措施: mFOLFOX6 or XELOX (Drug)
结局指标
主要结局
rates of grade 2 or more chronic cumulative neurotoxicity of both arms
时间窗: 9 months
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
次要结局
- rates of 3 year disease free survival of both arms(3 years)
- rates of chronic cumulative neurotoxicity of both arms(9 months)
- time to grade 2 or more neurotoxicity of both arms(9 months)
- rates of dose reduction or withdrawal due to oxaliplatin induced neurotoxicity of both arms(9 months)
- rates and grades of adverse reactions of both arms(6 months)
- rates of acute neurotoxicity of both arms(6 months)
研究者
Yuhong Li
MD Ph D
Sun Yat-sen University