Stage III Colorectal CancerMB-6NCT02135887
A Trial of MB-6 for Reduction of Neutropenia Induced by Chemotherapy in Patients With Stage III Colorectal Cancer.
An observational study of Stage III Colorectal Cancer and Neutropenia, run by Microbio Co Ltd at 1 site in Taiwan.
Trial summary
This is a randomized, double-blind, placebo-controlled multi-center phaseⅢstudy to evaluate efficacy and safety of oxaliplatin-based chemotherapy plus MB-6(320 mg/capsule, 6 capsules tid) in patients with stage 3 colorectal cancer who underwent surgical excision of their primary tumor. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stage III Colorectal Cancer, Neutropenia
- What is being tested?
- MB-6
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Nov 2013to 31 Dec 2022
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 184 patients with stage III colorectal cancer underwent surgery will be recruited into the study for receiving adjuvant therapy over 18 weeks.
Who may be able to join
- Men or women 20 years of age or older.
- Histologically or cytologically confirmed stage 3 colorectal adenocarcinoma.
- Complete resection of the primary tumor without gross or microscopic evidence of residual disease.
- No more than 8 weeks have elapsed from the time of surgery and have recovered from the effects.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) < 2 at the time of screening.
- Hematological function: ANC≥1500/mm3, Hemoglobin ≥9.0 g/dL, Platelet count ≥100000/mm3.
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- Kidney function:Serum creatinine <2 mg/dL.
- Liver function: AST ≤3 times ULN, ALT ≤3 times ULN, Total Bilirubin ≤2 times ULN.
- Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.
- Men and women of childbearing potential must agree to employ adequate contraception during the study period.
Who cannot join
- History of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Systemic chemotherapy, immune therapy or experimental or approved antibodies/proteins (e.g. bevacizumab) administered after surgery and prior to randomization.
- Concurrent treatment with any other anticancer therapy.
- Radiotherapy ≤14 days prior to randomization.
- Any unresolved toxicity > CTC (Common Toxicity Criteria) grade 1 from previous anti-cancer therapy (including radiotherapy) except haematological toxicity and alopecia.
- Patients with congestive heart failure, epilepsy, or other significant medical conditions as judged by the investigator.
- Contraindications to FOLFOX chemotherapy: peripheral neuropathy NCI CTC >1, liver failure, uncontrolled coronary heart disease, myocardial infarction within the previous 6 months before randomization.
- Patient of child-bearing potential is evidently pregnant or is breast feeding.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Microbio Co., Ltd.
Taipei
Clinical Project Manager, 886-2-2703-1298 ext. 191, mbclinical@microbio.com.tw
About this study
Official title: The Purpose of This Study is to Evaluate the Effectiveness of MB-6 as Adjuvant Therapy in Reducing Neutropenia When Given Oxaliplatin-based Chemotherapy in Patients With Stage 3 Colorectal Cancer Previously Treated With Surgery.
This is a randomized, double-blind, placebo-controlled multi-center phaseⅢstudy to evaluate efficacy and safety of oxaliplatin-based chemotherapy plus MB-6(320 mg/capsule, 6 capsules tid) in patients with stage 3 colorectal cancer who underwent surgical excision of their primary tumor.
Read the detailed description
The investigational new drug, MB-6, in the proposed clinical trial is to be used as an adjuvant therapy for metastatic colorectal cancer patients. All of six extracts have been used in human with a long history, and many literatures reported the medicinal use either individually or as ingredients of formulations. MB-6 may provide its therapeutic benefits via inhibition of tumor induction or enhancing the efficacy of chemotherapy in colorectal cancer.
- Conditions
- Stage III Colorectal Cancer, Neutropenia
- Being tested
- MB-6, Placebo
- Keywords
- Stage III Colorectal Cancer, Grade 4 Neutropenia, MB-6
- Medical subject headings
- Colorectal Neoplasms, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB-6Drug
Also called Folinic acid; Fluorouracil ; Oxaliplatin
6# TID with meal
PlaceboDrug
Also called Folinic acid; Fluorouracil ; Oxaliplatin
6# TID with meal
| Study group | Role | What they receive |
|---|---|---|
| MB-6+FOLFOX chemotherapy | MB-6, 6 capsules tid be taken with meals plus FOLFOX chemotherapy, will be given for 18 weeks Receives: Drug: MB-6 | |
| Placebo+FOLFOX chemotherapy | Placebo, 6 capsules tid be taken with meals plus FOLFOX chemotherapy, will be given for 18 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy period, defined as an absolute neutrophil count (ANC) <500/mm3.
The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy, defined as an absolute neutrophil count (ANC)<500/mm3
Measured: 18 weeks
Secondary outcomes (8)
Time to first Grade 4 Neutropenia
To determine the time interval from randomization to the first episode of grade 4 Neutropenia.
The analyses for incidence of study event will be conducted using logistic regression model method to adjust for gender and the regimen of chemotherapy (e.g., FOLFOX4 or FOLFOX6).
Measured: 18 weeks
Incidence of Febrile Neutropenia
The febrile neutropenia is defined as an ANC <1000/mm3 and a single temperature ≥38.3 degree of C or a sustained temperature of ≥38.0 degree C for more than one hour.
Measured: 18 weeks
Incidence of Grade 3 or 4 Neutropenia
The grade 3 or 4 neutropenia during the chemotherapy period is defined as an absolute neutrophil count (ANC) <1000/mm3.
Measured: 18 weeks
Change in Serum Creatinine level
Any change in Serum Creatinine level during the chemotherapy period
Measured: 18 weeks
Health-Related Quality of Life (HRQoL) - QLQ-C30
Health-Related Quality of Life (HRQoL) - QLQ-C30 should be completed at baseline, day 71 and end of study.
Measured: 18 weeks
Quality of Life -VAS on Fatigue, Constipation, Appetite
Quality of Life -VAS on Fatigue, Constipation, Appetite will be assessed by patients every two weeks until end of study.
Measured: 18 weeks
Compliance with Chemotherapy
The compliance with chemotherapy will be summarized by descriptive statistic and listed by each cycle and overall period.
Measured: 18 weeks
Increase in Body Weight
Any increased body weight during the chemotherapy period.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study start4 Nov 2013
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Colorectal CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Microbio Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Chen, M.D., Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135887
- Sponsor's protocol ID
- MB104CLCT02
- Acronym
- MB-6
- Status last verified
- Dec 2020
- First submitted
- 6 May 2014
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Purpose of This Study is to Evaluate the Effectiveness of MB-6 as Adjuvant Therapy in Reducing Neutropenia When Given Oxaliplatin-based Chemotherapy in Patients With Stage 3 Colorectal Cancer Previously Treated With Surgery.
- ClinicalTrials.gov ID
- NCT02135887
- Acronym / sponsor ID
- MB-6 / MB104CLCT02
- Conditions
- Stage III Colorectal Cancer, Neutropenia
- Keywords
- Stage III Colorectal Cancer, Grade 4 Neutropenia, MB-6
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Microbio Co LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2013 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 May 2014 (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.
This is a randomized, double-blind, placebo-controlled multi-center phaseⅢstudy to evaluate efficacy and safety of oxaliplatin-based chemotherapy plus MB-6(320 mg/capsule, 6 capsules tid) in patients with stage 3 colorectal cancer who underwent surgical excision of their primary tumor.
Detailed description
The investigational new drug, MB-6, in the proposed clinical trial is to be used as an adjuvant therapy for metastatic colorectal cancer patients. All of six extracts have been used in human with a long history, and many literatures reported the medicinal use either individually or as ingredients of formulations. MB-6 may provide its therapeutic benefits via inhibition of tumor induction or enhancing the efficacy of chemotherapy in colorectal cancer.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MB-6+FOLFOX chemotherapy | – | Drug: MB-6MB-6, 6 capsules tid be taken with meals plus FOLFOX chemotherapy, will be given for 18 weeks |
| Placebo+FOLFOX chemotherapy | – | Drug: PlaceboPlacebo, 6 capsules tid be taken with meals plus FOLFOX chemotherapy, will be given for 18 weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 184 patients with stage III colorectal cancer underwent surgery will be recruited into the study for receiving adjuvant therapy over 18 weeks.
Key inclusion criteria (10 listed)
- Men or women 20 years of age or older.
- Histologically or cytologically confirmed stage 3 colorectal adenocarcinoma.
- Complete resection of the primary tumor without gross or microscopic evidence of residual disease.
- No more than 8 weeks have elapsed from the time of surgery and have recovered from the effects.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) < 2 at the time of screening.
Key exclusion criteria (8 listed)
- History of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Systemic chemotherapy, immune therapy or experimental or approved antibodies/proteins (e.g. bevacizumab) administered after surgery and prior to randomization.
- Concurrent treatment with any other anticancer therapy.
- Radiotherapy ≤14 days prior to randomization.
- Any unresolved toxicity > CTC (Common Toxicity Criteria) grade 1 from previous anti-cancer therapy (including radiotherapy) except haematological toxicity and alopecia.
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 |
|---|---|---|
| MB-6Also: Folinic acid; Fluorouracil ; Oxaliplatin6# TID with meal | Drug | MB-6+FOLFOX chemotherapy |
| PlaceboAlso: Folinic acid; Fluorouracil ; Oxaliplatin6# TID with meal | Drug | Placebo+FOLFOX chemotherapy |
Primary outcome
The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy period, defined as an absolute neutrophil count (ANC) <500/mm3.
Time frame: 18 weeks
The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy, defined as an absolute neutrophil count (ANC)<500/mm3
8 secondary outcomes
Time to first Grade 4 Neutropenia
Time frame: 18 weeks
Incidence of Febrile Neutropenia
Time frame: 18 weeks
Incidence of Grade 3 or 4 Neutropenia
Time frame: 18 weeks
Change in Serum Creatinine level
Time frame: 18 weeks
Health-Related Quality of Life (HRQoL) - QLQ-C30
Time frame: 18 weeks
Quality of Life -VAS on Fatigue, Constipation, Appetite
Time frame: 18 weeks
Compliance with Chemotherapy
Time frame: 18 weeks
Increase in Body Weight
Time frame: 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
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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.
William Chen, M.D. principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage III Colorectal Cancer and Neutropenia, run by Microbio Co Ltd at 1 site in Taiwan.
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 10 inclusion and 8 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 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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.
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 William Chen, M.D. (886-4-22052121 ext. 1638, wtchen@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy period, defined as an absolute neutrophil count (ANC) <500/mm3. (time frame: 18 weeks). 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 22 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.