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

Primary Purpose

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

Status

Unknown status

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

metformin

control

About this trial

This is an interventional prevention trial for Non-DM Stage II High-risk Colorectal Cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Department of Internal Medicine, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

metformin

control

Arm Description

Outcomes

Primary Outcome Measures

Disease free survival

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

Secondary Outcome Measures

5-year overall survival

recurrence rate of polyps after polypectomy

Full Information

NCT ID

NCT02614339

First Posted

November 23, 2015

Last Updated

September 15, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02614339

Brief Title

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

Official Title

Effect of Adjunctive Metformin on Recurrence of Non-DM Colorectal Cancer Stage II High-risk/ III Colorectal Cancer: Open-label Randomized Controlled

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

July 2021 (Anticipated)

Study Completion Date

July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

593 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

metformin

Arm Type

Experimental

Arm Title

control

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

metformin

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

control

Intervention Description

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

Primary Outcome Measure Information:

Title

Disease free survival

Description

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

Time Frame

after 3 years

Secondary Outcome Measure Information:

Title

5-year overall survival

Time Frame

after 5 years

Title

recurrence rate of polyps after polypectomy

Time Frame

after 1 year, and then according to the findings in 1 year colonoscopy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tae Il Kim, MD

Phone

82-02-2228-1965

taeilkim@yuhs.ac

Facility Information:

Facility Name

Department of Internal Medicine, Yonsei University College of Medicine

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

TAE IL KIM, MD

Phone

82-2-2228-1965

taeilkim@yuhs.ac

12. IPD Sharing Statement

Learn more about this trial

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

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