Effect of Adjunctive Metformin on Recurrence of Non-DM Colorectal Cancer Stage II High-risk/ III Colorectal Cancer

Phase 3

• Conditions: Non-DM Stage II High-risk Colorectal Cancer; Non-DM Stage III Colorectal Cancer
• Interventions: Drug: control; Drug: metformin

• Registration Number: NCT02614339
• Lead Sponsor: Yonsei University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-25
• Study Start: 2015-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-15
• Last Update Posted: 2019-09-18
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 593

Inclusion Criteria

1. 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
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

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Exclusion Criteria

1. patients with DM
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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control	-
metformin	metformin	-

Primary Outcome Measures

Name	Time	Method
Disease free survival	after 3 years	The primary endpoint is to compare 3-year disease free survival between metformin group and non-metformin group.

Secondary Outcome Measures

Name	Time	Method
recurrence rate of polyps after polypectomy	after 1 year, and then according to the findings in 1 year colonoscopy
5-year overall survival	after 5 years

Trial Locations

Locations (1)

Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of