Clinical Trial: Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: Sunnybrook Health Sciences Centre

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Sunnybrook Health Sciences Centre

Dates:
Date Received: December 20, 2016
Date Started: December 2016
Date Completion: December 2017
Last Updated: April 17, 2017
Last Verified: April 2017