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.
it is a placebo controlled phase III trial. Investigators plan to enroll 240 patients with 1:1 to A arm and B arm
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
240
it is extracted from pig's brain,shenjie is the brand name
saline of the same appearance as monosialotetrahexosylganglioside Sodium
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGTianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGThe incidence of neurotoxicity including acute neurotoxicity and accumulating neurotoxicity
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
Time frame: From the first day of chemotherapy to 12 months after study or until one week before the patients receive second-line chemotherapy
Objective response rate
investigators assess the effect every six weeks and objective response is recorded as complete response,partial response or stable disease according to Recist 1.1
Time frame: Eevery 6 weeks, up to 24 months
Progress Free Survival
From date of randomization until the date of first documented progression
Time frame: investigators assess the effect of chemotherapy every 6 weeks ,up to 24 months
overall Survival
the patients will be followed one month after progression ,then every 3 months,up to 100 months
Time frame: From date of randomization until the date of death from any cause, assessed up to 100 months
quality of life
investigators use sf-36 to evaluated the quality of life
Time frame: evaluate 1 week before chemotherapy and every 6 weeks of study. And evaluate within 4 weeks after the patients out of the study
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