Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in mCRC

Colorectal Cancer Clinical Trial

Official title:

The Safety and Effect of Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX6 as First-line Chemotherapy for Advanced Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02024412
• Other study ID #: 20131123
• Secondary ID: E2013109A
• Status: Recruiting
• Phase: Phase 3
• First received: November 24, 2013
• Last updated: September 24, 2015
• Start date: November 2013
• Est. completion date: December 2017

Study information

• Verified date: September 2015
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Yi Ba, MD PHD
• Phone: +86 02223340123-1051
• Email: zhobualing123[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

it is a placebo controlled phase III trial. investigators plan to enroll 240 patients with 1:1 to A arm and B arm

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Neurotoxicity Syndromes

Intervention

Drug:
• monosialotetrahexosylganglioside Sodium
it is a component extract from pig's brain,shenjie is the brand name

Other:
• placebo
saline of the same appearance as monosialotetrahexosylganglioside Sodium

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From the first day of chemotherapy to 12 months after study or until one week before the patients receive second-line chemotherapy	Yes
Secondary	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	Eevery 6 weeks, up to 24 months	No
Secondary	Progress Free Survival	From date of randomization until the date of first documented progression	investigators assess the effect of chemotherapy every 6 weeks ,up to 24 months	No
Secondary	overall Survival	the patients will be followed one month after progression ,then every 3 months,up to 100 months	From date of randomization until the date of death from any cause, assessed up to 100 months	No
Secondary	quality of life	we use sf-36 to evaluated the 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	No