Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in mCRC

Phase 3UnknownNCT02024412

Tianjin Medical University Cancer Institute and Hospital240 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

240

Conditions

Colorectal Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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