Effect of Adjunctive Metformin on Recurrence of Non-DM Stage III Colorectal Cancer: Open-label Randomized Controlled Study
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|ClinicalTrials.gov Identifier: NCT02614339|
Recruitment Status : Recruiting
First Posted : November 25, 2015
Last Update Posted : January 28, 2019
The aim of this study is to identify the effect of adjunctive metformin on recurrence of non-DM stage 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.
|Condition or disease||Intervention/treatment||Phase|
|Non-DM Stage III Colorectal Cancer||Drug: metformin Drug: control||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||593 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
The patients of this group are treated according to NCCN guideline for stage 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 35 months (total 36months including the adjustment period).
|Active Comparator: control||
The patients of this group are treated according to NCCN guideline for stage III colorectal cancer.
- 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.
- 5-year overall survival [ Time Frame: after 5 years ]
- recurrence rate of polyps after polypectomy [ Time Frame: every 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614339
|Contact: Tae Il Kim, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Department of Internal Medicine, Yonsei University College of Medicine||Recruiting|
|Seoul, Korea, Republic of, 120-752|
|Contact: TAE IL KIM, MD 82-2-2228-1965 email@example.com|