The Safety and Effect of Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX6 as First-line Chemotherapy for Advanced Colorectal Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The incidence of neurotoxicity including acute neurotoxicity and accumulating neurotoxicity
研究概览
简要总结
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.
详细描述
it is a placebo controlled phase III trial. investigators plan to enroll 240 patients with 1:1 to A arm and B arm
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients shall have normal organic function such as liver function, Cardiac function and renal function;
- •age >18 years old;
- •diagnosis mCRC with histology;
- •Did not received first-line chemotherapy
- •Karnofsky Performance scores >70 scores
- •should have target lesions or non-target lesions
- •For patients received oxaliplatin before, the residual neurotoxicity should less than grade 2
- •For diabetes without neuropathy, blood glucose before meal should less than 8mmol/L and HBA1C<7.0%
- •Patients should be expected to live no shorter than 3 months
排除标准
- •patients who is receiving chemotherapy;
- •WBC<4.0×109/L，ANC<1.5×109/L,PLT<100×109/L，Hb<90g/L,TBIL>1.5Limitation;BUN）>1.5Limitation；Cr）>1.5Limitation；ALT or AST>2.5Limitation（without liver metastasis）；ALT or AST）>5Limitation（with liver metastasis）;
- •heart dysfunction;
- •brain metastasis;
- •peripheral nervous system or central nervous system abnormal including diabetes mellitus patients with neuropathy;
- •patients who received Glutathione, acetylcysteine, calcium / magnesium, amifostine, carbamazepine, B vitamins, vitamin E within 30 days
研究组 & 干预措施
monosialotetrahexosylganglioside Sodium
arm A: monosialotetrahexosylganglioside Sodium Injection, 40mg,one hour before chemotherapy(mFOLFOX6), every two weeks until tumor progress or patients become intolerant
干预措施: monosialotetrahexosylganglioside Sodium (Drug)
placebo
arm B: equal saline as placebo ,one hour before chemotherapy(mFOLFOX6) every two weeks until tumor progress or intolerant
干预措施: placebo (Other)
结局指标
主要结局
The incidence of neurotoxicity including acute neurotoxicity and accumulating neurotoxicity
时间窗: From the first day of chemotherapy to 12 months after study or until one week before the patients receive second-line chemotherapy
Acute neurotoxicity will be assessed the first day of oxaliplatin at every cycle given;accumulating neurotoxicity will be assessed every two weeks from the second day of first cycle until the patients out of the study. The accumulating neurotoxicity will be assessed every four weeks for 12 months or one week before second-line chemotherapy
次要结局
- Objective response rate(Eevery 6 weeks, up to 24 months)
- Progress Free Survival(investigators assess the effect of chemotherapy every 6 weeks ,up to 24 months)
- overall Survival(From date of randomization until the date of death from any cause, assessed up to 100 months)
- quality of life(evaluate 1 week before chemotherapy and every 6 weeks of study. And evaluate within 4 weeks after the patients out of the study)