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Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in mCRC

Primary Purpose

Colorectal 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 Colorectal Cancer focused on measuring metastatic colorectal 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 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

Sites / Locations

  • Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

monosialotetrahexosylganglioside Sodium

placebo

Arm Description

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

arm B: equal saline as placebo ,one hour before chemotherapy(mFOLFOX6) every two weeks until tumor progress or 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
we use sf-36 to evaluated the quality of life

Full Information

First Posted
November 24, 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
NCT02024412
Brief Title
Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in mCRC
Official Title
The Safety and Effect of Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX6 as First-line Chemotherapy for Advanced Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 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
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

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

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
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
arm B: equal saline as placebo ,one hour before chemotherapy(mFOLFOX6) every two weeks until tumor progress or intolerant
Intervention Type
Drug
Intervention Name(s)
monosialotetrahexosylganglioside Sodium
Other Intervention Name(s)
shenjie
Intervention Description
it is a component extract 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
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

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 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 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
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 mCRC

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