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Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03053544
Recruitment Status : Completed
First Posted : February 15, 2017
Last Update Posted : September 27, 2019
Sponsor:
Collaborators:
Sunnybrook Research Institute
University of Toronto
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE December 20, 2016
First Posted Date  ICMJE February 15, 2017
Last Update Posted Date September 27, 2019
Study Start Date  ICMJE December 8, 2016
Actual Primary Completion Date June 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
Pathological Complete Response (pCR) rate [ Time Frame: 1 year ]
The primary outcome is to evaluate the use of metformin to improve pathological complete response (pCR) rates in non‐diabetic participants undergoing standard of care neoadjuvant CRT for rectal cancer. The primary outcome will be measured by the pathological complete response rate after completion of the study treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03053544 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
  • Tumor Proliferation Reduction [ Time Frame: 1 year ]
    The secondary outcome is to determine if metformin reduces tumor proliferation in this study population. The secondary outcome will be determined by examining tumor cell proliferation from longitudinal biopsy specimens.
  • Tumor Hypoxia [ Time Frame: 1 year ]
    The secondary outcome is to determine if metformin reduces tumor hypoxia in this study population. The secondary outcome will be determined by examining tumor cell hypoxia from longitudinal biopsy specimens.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer
Official Title  ICMJE Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer: An Internal Pilot Study
Brief Summary This study is a phase II, single arm, controlled, open label internal pilot.
Detailed Description This internal pilot will be the first prospective study to assess the feasibility and efficacy of adding metformin in non‐diabetic rectal patients who undergo standard of care neoadjuvant chemoradiation therapy (CRT). The translational aim of the study will inform on predictive factors (such as p53) and mechanism of action (hypoxia, proliferation). Metformin has been used for decades in patients with type 2 diabetes and has an extremely safe toxicity profile. With current interest in the use of metformin as a cancer therapeutic in non‐diabetics, this study is expected to provide proof‐of principle data for a larger study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rectal Neoplasm Carcinoma in Situ Adenocarcinoma
Intervention  ICMJE Drug: Metformin
Participants will self‐administer 500mg metformin twice daily by mouth: 1) beginning 1-2 weeks prior to standard of care CRT, 2) during standard of care CRT and 3) until 30 days after the end of standard of care CRT.
Study Arms  ICMJE Experimental: Metformin
Participants will self‐administer 500mg metformin twice daily by mouth: 1) beginning 1 to 2 weeks prior to standard of care CRT, 2) during standard of care CRT and 3) until 30 days after the end of standard of care CRT.
Intervention: Drug: Metformin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2017)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 26, 2019
Actual Primary Completion Date June 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Plan for care inclusive of:

    i. standard of care neoadjuvant chemoradiation ii. planned total mesorectal excision (TME)

  2. Histologically confirmed adenocarcinoma of the rectum
  3. At least one of the following:

    i. T3 or T4 lesions ii. T2 lesions ≤ 1 mm to the mesorectal fascia iii. Node positive rectal tumor

  4. ECOG performance status of 0 or 1
  5. Provide written informed consent
  6. Female participants of childbearing potential agree to use adequate methods of contraception from the start of metformin administration until the start of CRT. Contraception will not be required to be continued during or after CRT as this treatment renders participants infertile. Clinically acceptable methods of birth control for this study include intrauterine devices (IUD), birth control pills, hormonal implants, injectable contraceptives, and using barrier methods such as condoms, vaginal diaphragm with spermicide, or sponge.

Exclusion Criteria:

  1. Diagnosis of diabetes
  2. Current use of metformin
  3. Prior pelvic radiation
  4. Life expectancy < 6 months.
  5. Active infection
  6. Creatinine > 1.5X ULN, within 1 month prior to baseline
  7. AST, ALT > 2.5X ULN, within 1 month prior to baseline
  8. Bilirubin > 1.5 ULN, within 1 month prior to baseline
  9. Pregnant or breastfeeding women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03053544
Other Study ID Numbers  ICMJE 472-2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Results from this internal pilot will be disseminated to participants and stakeholders by means of publication and presentation where appropriate.
Responsible Party Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE
  • Sunnybrook Research Institute
  • University of Toronto
Investigators  ICMJE
Principal Investigator: Shun Wong, MD Sunnybrook Health Sciences Centre
Principal Investigator: Marianne Koritzinsky, MD Princess Margaret Hospital, Canada
PRS Account Sunnybrook Health Sciences Centre
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP