임상연구정보서비스

Search: Search

Effect of adjunctive metformin on recurrence of non-DM colorectal cancer stage II high-risk/ III colorectal cancer: Open-label randomized controlled

Status Approved

First Submitted Date

2019/08/08
Registered Date

2019/08/23
Last Updated Date

2020/11/10

Move list page

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0004236
Unique Protocol ID	4-2015-0533
Public/Brief Title	Effect of adjunctive metformin on recurrence of non-DM colorectal cancer
Scientific Title	Effect of adjunctive metformin on recurrence of non-DM colorectal cancer stage II high-risk/ III colorectal cancer: Open-label randomized controlled
Acronym
MFDS Regulated Study	Yes
IND/IDE Protocol	No
Registered at Other Registry	Yes
Name of Registry / Registration Number
Healthcare Benefit Approval Status	Submitted approval

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	4-2015-0533
Approval Date	2016-07-02
Institutional Review Board Name	Yonsei University Health system, Severance Hospital, Institutional Review Board
Institutional Review Board Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul
Institutional Review Board Telephone	02-2228-0435
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Tae Il Kim
Title	Professor
Telephone	+82-2-2228-1965
Affiliation	Yonsei University Health System, Severance Hospital
Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul
Contact Person for Public Queries
Name	Tae Il Kim
Title	Professor
Telephone	+82-2-2228-1965
Affiliation	Yonsei University Health System, Severance Hospital
Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul
Contact Person for Updating Information
Name	Yoonjeong Lee
Title	Study coordinator
Telephone	+82-2-2228-0557
Affiliation	Yonsei University Health System, Severance Hospital
Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 4
Overall Recruitment Status	Recruiting
Date of First Enrollment	2016-07-08 Actual
Target Number of Participant	593
Primary Completion Date	2021-07-23 , Anticipated
Study Completion Date	2021-07-23 , Anticipated
Name of Study	Yonsei University Health System, Severance Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2016-07-08 ,
Recruitment Status by Participating Study Site 2
Name of Study	Kosin University Gospel Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2020-08-28 ,
Recruitment Status by Participating Study Site 3
Name of Study	Korea University Anam Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2020-09-14 ,
Recruitment Status by Participating Study Site 4
Name of Study	Chosun University Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-01-04 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Yonsei University Health System, Severance Hospital
Organization Type	Medical Institute
Project ID	4-2015-0533

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Yonsei University Health System, Severance Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	This study is an open label randomized controlled clinical trial to examine the effect of adjunctive metformin on recurrence of non-DM colorectal cancer stage II high-risk/ III colorectal cancer. The 1g/day of metformin will be given to patients during adjuvant chemotherapy after surgery and continued for 4 years.

Study Summary Information

Lay Summary

This study is an open label randomized controlled clinical trial to examine the effect of adjunctive metformin on recurrence of non-DM colorectal cancer stage II high-risk/ III colorectal cancer. The 1g/day of metformin will be given to patients during adjuvant chemotherapy after surgery and continued for 4 years.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Phase2
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Drug
Intervention Description	This study is an open label randomized controlled clinical trial to examine the effect of adjunctive metformin on recurrence of non-DM colorectal cancer stage II high-risk/ III colorectal cancer. The 1g/day of metformin will be given to patients during adjuvant chemotherapy after surgery and continued for 4 years.
Number of Arms	2
Arm 1	Arm Label metformin group
	Target Number of Participant 296
	Arm Type Experimental
	Arm Description The 1g/day of metformin will be given to patients during adjuvant chemotherapy after surgery and continued for 4 years.
Arm 2	Arm Label control group
	Target Number of Participant 297
	Arm Type Active comparator
	Arm Description The patients of this group are treated according to NCCN guideline for stage II high-risk/ III colorectal cancer.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C20)Malignant neoplasm of rectum colorectal neoplasm, recurrence, chemotherapy, metformin
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~80Year
	Description A. Colorectal cancer stage II high-risk/ III colorectal cancer patients B. Age range of 20-80 C. Non-diabetes patients D. Patients who have chemotherapy-tolerable general condition E. Patient who agree with the study
Exclusion Criteria	A. Patients who had diabetes before diagnosis of colorectal cancer, B. Insufficient medical records C. History of other cancer within 5 years D. Serious combined diseases (kidney, lung, liver, and infectious diseases or sepsis) E. Other inadequate medical conditions for clinial trials
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	recurrence rate
Timepoint	3 years after surgery
Secondary Outcome(s) 1
Outcome	5 years survival
Timepoint	5 years after surgery
Secondary Outcome(s) 2
Outcome	adverse effect
Timepoint	5 years after surgery
Secondary Outcome(s) 3
Outcome	recurrence rate of colorectal polyp
Timepoint	5 years after surgery

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

Move list page Move to top