A Phase 3 interventional study of monosialotetrahexosylganglioside Sodium and placebo in Colorectal Cancer, sponsored by Tianjin Medical University Cancer Institute and Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-28.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 3, Interventional, and Prevention
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.
it is a placebo controlled phase III trial. investigators plan to enroll 240 patients with 1:1 to A arm and B arm
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 240 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
arm A: monosialotetrahexosylganglioside Sodium Injection, 40mg,one hour before chemotherapy(mFOLFOX6), every two weeks until tumor progress or patients become intolerant
Drug: monosialotetrahexosylganglioside Sodium
arm B: equal saline as placebo ,one hour before chemotherapy(mFOLFOX6) every two weeks until tumor progress or intolerant
Other: placebo
it is a component extract from pig's brain,shenjie is the brand name
Also known as: shenjie
saline of the same appearance as monosialotetrahexosylganglioside Sodium
Also known as: saline
The 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
we 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
This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University Cancer Institute and Hospital