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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
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 593 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : December 2015
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: metformin Drug: metformin
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 Drug: control
The patients of this group are treated according to NCCN guideline for stage III colorectal cancer.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 5-year overall survival [ Time Frame: after 5 years ]
  2. recurrence rate of polyps after polypectomy [ Time Frame: every 4 weeks ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients with stage 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

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

Information from the National Library of Medicine

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


Contacts
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Contact: Tae Il Kim, MD 82-02-2228-1965 taeilkim@yuhs.ac

Locations
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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    taeilkim@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02614339     History of Changes
Other Study ID Numbers: 4-2015-0533
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Metformin
Hypoglycemic Agents
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Physiological Effects of Drugs