Effect of Adjunctive Metformin on Recurrence of Non-DM Colorectal Cancer Stage II High-risk/ III Colorectal Cancer
NCT ID: NCT02614339
Last Updated: 2019-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
593 participants
INTERVENTIONAL
2015-12-31
2021-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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metformin
metformin
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).
control
control
The patients of this group are treated according to NCCN guideline for stage II high-risk/ III colorectal cancer.
Interventions
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metformin
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).
control
The patients of this group are treated according to NCCN guideline for stage II high-risk/ III colorectal cancer.
Eligibility Criteria
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Inclusion Criteria
2. age 20 - 80 years
3. patients without DM
4. patients who have well performance status for chemotherapy
5. patients who are agreed the study protocol
Exclusion Criteria
2. patients who were diagnosed other cancers (≥ stage II) within 5 years
3. patients who have familial adenomatous polyposis, hereditary non-polyposis colorectal cancer, or inflammatory bowel disease
4. patients who are taken other chemoprevention drugs (ex. NSAIDs, Aspirin)
5. patients who have risk factors to increase lactic acidosis which are renal disease, lung disease, liver disease, or infectious disease
6. Creatinine ≥ 1.5mg/dL (for male), ≥ 1.4mg/dL (for female)
7. patients with congestive heart failure which is needed to treat
8. patients who have allergic history of metformin
9. pregnancy
20 Years
80 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Department of Internal Medicine, Yonsei University College of Medicine
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-2015-0533
Identifier Type: -
Identifier Source: org_study_id
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