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

NCT02614339 | Unknown Phase 3 DMC

• 1 other identifier: 4-2015-0533
• Study Type: interventional
• Target: 593
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-DM Stage II High-risk Colorectal Cancer; Non-DM Stage III Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  The primary endpoint is to compare 3-year disease free survival between metformin group and non-metformin group.

  after 3 years

Secondary Outcomes (2)

• 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

Study Arms (2)

metformin

EXPERIMENTAL

Drug: metformin

control

ACTIVE COMPARATOR

Drug: control

Interventions

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).

metformin

control DRUG

The patients of this group are treated according to NCCN guideline for stage II high-risk/ III colorectal cancer.

control

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• patients with congestive heart failure which is needed to treat
• patients who have allergic history of metformin
• pregnancy

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Internal Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Tae Il Kim, MD

CONTACT

82-02-2228-1965; taeilkim@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 25, 2015
• Study Start: December 1, 2015
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 18, 2019

Record last verified: 2019-09

Locations

KR (1)