Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in mCRC

Phase 3

• Conditions: Colorectal Cancer
• Interventions: Drug: monosialotetrahexosylganglioside Sodium; Other: placebo

• Registration Number: NCT02024412
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-24
• Study First Submitted QC: 2013-12-26
• Study First Posted: 2013-12-31
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-28
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
monosialotetrahexosylganglioside Sodium	monosialotetrahexosylganglioside Sodium	arm A: monosialotetrahexosylganglioside Sodium Injection, 40mg,one hour before chemotherapy(mFOLFOX6), every two weeks until tumor progress or patients become intolerant
placebo	placebo	arm B: equal saline as placebo ,one hour before chemotherapy(mFOLFOX6) every two weeks until tumor progress or intolerant

Primary Outcome Measures

Name	Time	Method
The incidence of neurotoxicity including acute neurotoxicity and accumulating neurotoxicity	From the first day of chemotherapy to 12 months after study or until one week before the patients receive second-line chemotherapy	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

Secondary Outcome Measures

Name	Time	Method
Objective response rate	Eevery 6 weeks, up to 24 months	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
Progress Free Survival	investigators assess the effect of chemotherapy every 6 weeks ,up to 24 months	From date of randomization until the date of first documented progression
overall Survival	From date of randomization until the date of death from any cause, assessed up to 100 months	the patients will be followed one month after progression ,then every 3 months,up to 100 months
quality of life	evaluate 1 week before chemotherapy and every 6 weeks of study. And evaluate within 4 weeks after the patients out of the study	we use sf-36 to evaluated the quality of life

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China