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Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in Advanced Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
monosialotetrahexosylganglioside Sodium
placebo
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Cancer focused on measuring metastatic gastric cancer, neurotoxicity, mFOLFOX6, monosialotetrahexosylganglioside Sodium Injection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 metastatic colorectal cancer with histology;
  4. Did not received first-line chemotherapy
  5. Karnofsky Performance scores should be 60,70,or80
  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

Sites / Locations

  • Tianjin Medical University Cancer Institute and HospitalRecruiting
  • Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

placebo

monosialotetrahexosylganglioside Sodium

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Progress Free Survival
From date of randomization until the date of first documented progression
overall Survival
the patients will be followed one month after progression ,then every 3 months,up to 100 months
quality of life
investigators use sf-36 to evaluated the quality of life

Full Information

First Posted
December 1, 2013
Last Updated
September 24, 2015
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02024438
Brief Title
Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in Advanced Gastric Cancer
Official Title
The Safety and Effect of Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX6 as First-line Chemotherapy for Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
For gastric patients of Karnofsky scores between 60-80 scores, mFolfox6 is an option for chemotherapy. 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. A phase III trial is needed to investigate the effect and safety of monosialotetrahexosylganglioside Sodium Injection for prevention OIN at gastric 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
metastatic gastric cancer, neurotoxicity, mFOLFOX6, monosialotetrahexosylganglioside Sodium Injection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Other
Arm Description
arm B: equal saline as placebo ,one hour before chemotherapy(mFOLFOX6) every two weeks until tumor progress or intolerant
Arm Title
monosialotetrahexosylganglioside Sodium
Arm Type
Experimental
Arm Description
arm A: monosialotetrahexosylganglioside Sodium Injection, 40mg,one hour before chemotherapy(mFOLFOX6), every two weeks until tumor progress or patients become intolerant
Intervention Type
Drug
Intervention Name(s)
monosialotetrahexosylganglioside Sodium
Other Intervention Name(s)
brand name : shenjie
Intervention Description
it is extracted from pig's brain,shenjie is the brand name
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
saline
Intervention Description
saline of the same appearance as monosialotetrahexosylganglioside Sodium
Primary Outcome Measure Information:
Title
The incidence of neurotoxicity including acute neurotoxicity and accumulating neurotoxicity
Description
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 Outcome Measure Information:
Title
Objective response rate
Description
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
Title
Progress Free Survival
Description
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
Title
overall Survival
Description
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
Title
quality of life
Description
investigators 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients shall have normal organic function such as liver function, Cardiac function and renal function; age >18 years old; diagnosis metastatic colorectal cancer with histology; Did not received first-line chemotherapy Karnofsky Performance scores should be 60,70,or80 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YI Ba, MD PHD
Phone
+86 02223340123-1051
Email
zhobualing123@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Ba, MD.PHD
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YI BA, MD PHD
Phone
+8602223340123-1051
Email
zhoubaling123@163.com
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YI BA, MD PHD
Phone
+8602223340123-1051
Email
zhoubaling123@163.com
First Name & Middle Initial & Last Name & Degree
Likun Zhou, MD
First Name & Middle Initial & Last Name & Degree
yi ba, MD PHD

12. IPD Sharing Statement

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Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in Advanced Gastric Cancer

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