Gastric CancerPhase 3NCT02024438
Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in Advanced Gastric Cancer
A Phase 3 study testing monosialotetrahexosylganglioside Sodium in people with Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- monosialotetrahexosylganglioside Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2013to Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
YI BA, MD PHD, +8602223340123-1051, zhoubaling123@163.com
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
YI BA, MD PHD, +8602223340123-1051, zhoubaling123@163.com
Likun Zhou, MD
About this study
Official title: The Safety and Effect of Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX6 as First-line Chemotherapy for Advanced Gastric Cancer
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.
Read the 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
- Conditions
- Gastric Cancer
- Being tested
- monosialotetrahexosylganglioside Sodium, placebo
- Keywords
- metastatic gastric cancer, neurotoxicity, mFOLFOX6, monosialotetrahexosylganglioside Sodium Injection
- Medical subject headings
- Stomach Neoplasms, Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monosialotetrahexosylganglioside SodiumDrug
Also called brand name : shenjie
it is extracted from pig's brain,shenjie is the brand name
placeboOther
Also called saline
saline of the same appearance as monosialotetrahexosylganglioside Sodium
| Study group | Role | What they receive |
|---|---|---|
| placebo | Other | arm B: equal saline as placebo ,one hour before chemotherapy(mFOLFOX6) every two weeks until tumor progress or intolerant Receives: Other: placebo |
| monosialotetrahexosylganglioside Sodium | Experimental | arm A: monosialotetrahexosylganglioside Sodium Injection, 40mg,one hour before chemotherapy(mFOLFOX6), every two weeks until tumor progress or patients become intolerant Receives: Drug: monosialotetrahexosylganglioside Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: Eevery 6 weeks, up to 24 months
Progress Free Survival
From date of randomization until the date of first documented progression
Measured: investigators assess the effect of chemotherapy every 6 weeks ,up to 24 months
overall Survival
the patients will be followed one month after progression ,then every 3 months,up to 100 months
Measured: From date of randomization until the date of death from any cause, assessed up to 100 months
quality of life
investigators use sf-36 to evaluated the quality of life
Measured: evaluate 1 week before chemotherapy and every 6 weeks of study. And evaluate within 4 weeks after the patients out of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Ba, MD.PHD, Study director, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024438
- Sponsor's protocol ID
- 20131201
- Status last verified
- Sep 2015
- First submitted
- 1 Dec 2013
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effect of Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX6 as First-line Chemotherapy for Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT02024438
- Acronym / sponsor ID
- 20131201
- Conditions
- Gastric Cancer
- Keywords
- metastatic gastric cancer, neurotoxicity, mFOLFOX6, monosialotetrahexosylganglioside Sodium Injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Other | Other: placeboarm B: equal saline as placebo ,one hour before chemotherapy(mFOLFOX6) every two weeks until tumor progress or intolerant |
| monosialotetrahexosylganglioside Sodium | Experimental | Drug: monosialotetrahexosylganglioside Sodiumarm A: monosialotetrahexosylganglioside Sodium Injection, 40mg,one hour before chemotherapy(mFOLFOX6), every two weeks until tumor progress or patients become intolerant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| monosialotetrahexosylganglioside SodiumAlso: brand name : shenjieit is extracted from pig's brain,shenjie is the brand name | Drug | monosialotetrahexosylganglioside Sodium |
| placeboAlso: salinesaline of the same appearance as monosialotetrahexosylganglioside Sodium | Other | placebo |
Primary outcome
The incidence of neurotoxicity including acute neurotoxicity and accumulating neurotoxicity
Time frame: 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
4 secondary outcomes
Objective response rate
Time frame: Eevery 6 weeks, up to 24 months
Progress Free Survival
Time frame: investigators assess the effect of chemotherapy every 6 weeks ,up to 24 months
overall Survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 100 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Ba, MD.PHD study director
Tianjin Medical University Cancer Institute and Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing monosialotetrahexosylganglioside Sodium in people with Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YI Ba, MD PHD (+86 02223340123-1051, zhobualing123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of neurotoxicity including acute neurotoxicity and accumulating neurotoxicity (time frame: From the first day of chemotherapy to 12 months after study or until one week before the patients receive second-line chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.