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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metformin | Experimental |
| |
| control | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metformin | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | The primary endpoint is to compare 3-year disease free survival between metformin group and non-metformin group. | after 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year overall survival | after 5 years | |
| recurrence rate of polyps after polypectomy | after 1 year, and then according to the findings in 1 year colonoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tae Il Kim, MD | Contact | 82-02-2228-1965 | taeilkim@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Yonsei University College of Medicine | Recruiting | Seoul | 120-752 | South Korea |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| control | Drug | The patients of this group are treated according to NCCN guideline for stage II high-risk/ III colorectal cancer. |
|