Clinical trial NCT02024412: Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in mCRC
Official title: The Safety and Effect of Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX6 as First-line Chemotherapy for Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: metastatic colorectal 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: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 mCRC with histology;
4. Did not received first-line chemotherapy
5. Karnofsky Performance scores \>70 scores
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
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Yi Ba, MD.PHD
role: STUDY_DIRECTOR
References: