Non-DM Stage II High-risk Colorectal CancerPhase 3NCT02614339
Effect of Adjunctive Metformin on Recurrence of Non-DM Colorectal Cancer Stage II High-risk/ III Colorectal Cancer
A Phase 3 study testing metformin in people with Non-DM Stage II High-risk Colorectal Cancer and Non-DM Stage III Colorectal Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
The aim of this study is to identify the effect of adjunctive metformin on recurrence of non-DM Stage II High-risk/ III colorectal cancer. This study is open-label randomized controlled study. The primary endpoint is to compare the 3-year disease free survival between metformin group and non-metformin group. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Non-DM Stage II High-risk Colorectal Cancer, Non-DM Stage III Colorectal Cancer
- What is being tested?
- metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 593 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2015to Jul 2021
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with stage II high-risk/ III colorectal cancer who were taken an operation for cure, or patients with stage III rectal cancer who were taken an chemoradiation therapy and subsequently operation
- age 20 - 80 years
- patients without DM
- patients who have well performance status for chemotherapy
- patients who are agreed the study protocol
Who cannot join
- patients with DM
- patients who were diagnosed other cancers (≥ stage II) within 5 years
- patients who have familial adenomatous polyposis, hereditary non-polyposis colorectal cancer, or inflammatory bowel disease
- patients who are taken other chemoprevention drugs (ex. NSAIDs, Aspirin)
- patients who have risk factors to increase lactic acidosis which are renal disease, lung disease, liver disease, or infectious disease
- Creatinine ≥ 1.5mg/dL (for male), ≥ 1.4mg/dL (for female)
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- patients with congestive heart failure which is needed to treat
- patients who have allergic history of metformin
- pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 120-752
TAE IL KIM, MD, 82-2-2228-1965, taeilkim@yuhs.ac
About this study
Official title: Effect of Adjunctive Metformin on Recurrence of Non-DM Colorectal Cancer Stage II High-risk/ III Colorectal Cancer: Open-label Randomized Controlled
The aim of this study is to identify the effect of adjunctive metformin on recurrence of non-DM Stage II High-risk/ III colorectal cancer. This study is open-label randomized controlled study.
The primary endpoint is to compare the 3-year disease free survival between metformin group and non-metformin group. The secondary endpoint is to compare the 5-year overall survival and disease specific survival between two group, to identify the safety of metformin, and to compare the recurrence rate of polyps after polypectomy between two groups.
- Being tested
- metformin, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metforminDrug
The patients of this group are treated according to NCCN guideline for stage II high-risk/ III colorectal cancer and receive an additional prescription metformin. Metformin will be prescribed 1g/day (500mg, 2 table/day, or 1000mg, 1 table/day). After adjustment period for 1month, patients who do not have side effects will be taken metformin for additional 47 months (total 48months including the adjustment period).
controlDrug
The patients of this group are treated according to NCCN guideline for stage II high-risk/ III colorectal cancer.
| Study group | Role | What they receive |
|---|---|---|
| metformin | Experimental | Not described Receives: Drug: metformin |
| control | Active comparator | Not described Receives: Drug: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
The primary endpoint is to compare 3-year disease free survival between metformin group and non-metformin group.
Measured: after 3 years
Secondary outcomes (2)
5-year overall survival
Measured: after 5 years
recurrence rate of polyps after polypectomy
Measured: after 1 year, and then according to the findings in 1 year colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-DM Stage II High-risk Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- None (open label)
- Enrolment
- 593 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614339
- Sponsor's protocol ID
- 4-2015-0533
- Status last verified
- Sep 2019
- First submitted
- 23 Nov 2015
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adjunctive Metformin on Recurrence of Non-DM Colorectal Cancer Stage II High-risk/ III Colorectal Cancer: Open-label Randomized Controlled
- ClinicalTrials.gov ID
- NCT02614339
- Acronym / sponsor ID
- 4-2015-0533
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 593 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 25 Nov 2015 (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.
The aim of this study is to identify the effect of adjunctive metformin on recurrence of non-DM Stage II High-risk/ III colorectal cancer. This study is open-label randomized controlled study.
The primary endpoint is to compare the 3-year disease free survival between metformin group and non-metformin group. The secondary endpoint is to compare the 5-year overall survival and disease specific survival between two group, to identify the safety of metformin, and to compare the recurrence rate of polyps after polypectomy between two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin | Experimental | Drug: metformin |
| control | Active comparator | Drug: control |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with stage II high-risk/ III colorectal cancer who were taken an operation for cure, or patients with stage III rectal cancer who were taken an chemoradiation therapy and subsequently operation
- age 20 - 80 years
- patients without DM
- patients who have well performance status for chemotherapy
- patients who are agreed the study protocol
Key exclusion criteria (9 listed)
- patients with DM
- patients who were diagnosed other cancers (≥ stage II) within 5 years
- patients who have familial adenomatous polyposis, hereditary non-polyposis colorectal cancer, or inflammatory bowel disease
- patients who are taken other chemoprevention drugs (ex. NSAIDs, Aspirin)
- patients who have risk factors to increase lactic acidosis which are renal disease, lung disease, liver disease, or infectious disease
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 |
|---|---|---|
| metforminThe patients of this group are treated according to NCCN guideline for stage II high-risk/ III colorectal cancer and receive an additional prescription metformin. Metformin will be prescribed 1g/day (500mg, 2 table/day, or 1000mg, 1 table/day). After adjustment period for 1month, patients who do not have side effects will be taken metformin for additional 47 months (total 48months including the adjustment period). | Drug | metformin |
| controlThe patients of this group are treated according to NCCN guideline for stage II high-risk/ III colorectal cancer. | Drug | control |
Primary outcome
Disease free survival
Time frame: after 3 years
The primary endpoint is to compare 3-year disease free survival between metformin group and non-metformin group.
2 secondary outcomes
5-year overall survival
Time frame: after 5 years
recurrence rate of polyps after polypectomy
Time frame: after 1 year, and then according to the findings in 1 year colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing metformin in people with Non-DM Stage II High-risk Colorectal Cancer and Non-DM Stage III Colorectal Cancer, run by Yonsei University at 1 site in South Korea.
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 5 inclusion and 9 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 18 Sep 2019. 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 South Korea. 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 Tae Il Kim, MD (82-02-2228-1965, taeilkim@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: after 3 years). 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 18 Sep 2019.