Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in mCRC

NCT02024412 | Unknown Phase 3

• 2 other identifiers: 20131123E2013109A
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

metastatic colorectal cancer; neurotoxicity; mFOLFOX6; monosialotetrahexosylganglioside Sodium Injection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Objective response rate

  Eevery 6 weeks, up to 24 months

• Progress Free Survival

  investigators assess the effect of chemotherapy every 6 weeks ,up to 24 months

• overall Survival

  From date of randomization until the date of death from any cause, assessed 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

Study Arms (2)

monosialotetrahexosylganglioside Sodium

EXPERIMENTAL

arm A: monosialotetrahexosylganglioside Sodium Injection, 40mg,one hour before chemotherapy(mFOLFOX6), every two weeks until tumor progress or patients become intolerant

Drug: monosialotetrahexosylganglioside Sodium

placebo

PLACEBO COMPARATOR

arm B: equal saline as placebo ,one hour before chemotherapy(mFOLFOX6) every two weeks until tumor progress or intolerant

Other: placebo

Interventions

monosialotetrahexosylganglioside Sodium DRUG

it is a component extract from pig's brain,shenjie is the brand name

Also known as: shenjie

monosialotetrahexosylganglioside Sodium

placebo OTHER

saline of the same appearance as monosialotetrahexosylganglioside Sodium

Also known as: saline

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients shall have normal organic function such as liver function, Cardiac function and renal function;
• age \>18 years old;
• diagnosis mCRC with histology;
• Did not received first-line chemotherapy
• Karnofsky Performance scores \>70 scores
• should have target lesions or non-target lesions
• For patients received oxaliplatin before, the residual neurotoxicity should less than grade 2
• For diabetes without neuropathy, blood glucose before meal should less than 8mmol/L and HBA1C\<7.0%
• Patients should be expected to live no shorter than 3 months

You may not qualify if:

• patients who is receiving chemotherapy;
• 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）;
• heart dysfunction;
• brain metastasis;
• peripheral nervous system or central nervous system abnormal including diabetes mellitus patients with neuropathy;
• patients who received Glutathione, acetylcysteine, calcium / magnesium, amifostine, carbamazepine, B vitamins, vitamin E within 30 days

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Neurotoxicity Syndromes

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Yi Ba, MD.PHD

  Tianjin Medical University Cancer Institute and Hospital

  STUDY DIRECTOR

Central Study Contacts

Yi Ba, MD PHD

CONTACT

+86 02223340123-1051; zhobualing123@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2013
• First Posted: December 31, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

CN (1)