Clinical trial NCT02024438: Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in Advanced Gastric Cancer
Official title: The Safety and Effect of Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX6 as First-line Chemotherapy for Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: metastatic gastric cancer
neurotoxicity
mFOLFOX6
monosialotetrahexosylganglioside Sodium Injection
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: For gastric patients of Karnofsky scores between 60-80 scores, mFolfox6 is an option for chemotherapy. 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. A phase III trial is needed to investigate the effect and safety of monosialotetrahexosylganglioside Sodium Injection for prevention OIN at gastric cancer.

Detailed description: it is a placebo controlled phase III trial. Investigators plan to enroll 240 patients with 1:1 to A arm and B arm

Eligibility criteria: Inclusion Criteria:

1. Patients shall have normal organic function such as liver function, Cardiac function and renal function;
2. age \>18 years old;
3. diagnosis metastatic colorectal cancer with histology;
4. Did not received first-line chemotherapy
5. Karnofsky Performance scores should be 60,70,or80
6. should have target lesions or non-target lesions
7. For patients received oxaliplatin before, the residual neurotoxicity should less than grade 2
8. For diabetes without neuropathy, blood glucose before meal should less than 8mmol/L and HBA1C\<7.0%
9. Patients should be expected to live no shorter than 3 months

Exclusion Criteria:

1. patients who is receiving chemotherapy;
2. 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）;
3. heart dysfunction;
4. brain metastasis;
5. peripheral nervous system or central nervous system abnormal including diabetes mellitus patients with neuropathy;
6. patients who received Glutathione, acetylcysteine, calcium / magnesium, amifostine, carbamazepine, B vitamins, vitamin E within 30 days

Primary outcomes:
measure: The incidence of neurotoxicity including acute neurotoxicity and accumulating neurotoxicity
timeFrame: From the first day of chemotherapy to 12 months after study or until one week before the patients receive second-line chemotherapy
Secondary outcomes:
measure: Objective response rate
timeFrame: Eevery 6 weeks, up to 24 months
measure: Progress Free Survival
timeFrame: investigators assess the effect of chemotherapy every 6 weeks ,up to 24 months
measure: overall Survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 100 months
measure: quality of life
timeFrame: evaluate 1 week before chemotherapy and every 6 weeks of study. And evaluate within 4 weeks after the patients out of the study
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Yi Ba, MD.PHD
role: STUDY_DIRECTOR
References: