Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer

Official Title

Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer: An Internal Pilot Study

Summary:

This study is a phase II, single arm, controlled, open label internal pilot.

Trial Description

Primary Outcome:

  • Pathological Complete Response (pCR) rate
Secondary Outcome:
  • Tumour Proliferation Reduction
  • Tumour Hypoxia
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.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society