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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.

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.

Shun Wong, MD

Marianne Koritzinsky, MD

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

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.

Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer

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

Results from this internal pilot will be disseminated to participants and stakeholders by means of publication and presentation where appropriate.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer	NCT03053544	Rectal Neoplasm...	Metformin	19 Years -	Sunnybrook Health Sciences Centre
Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer	NCT03053544	Rectal Neoplasm...	Metformin	19 Years -	Sunnybrook Health Sciences Centre

Spots Global Cancer Trial Database for rectal neoplasm carcinoma in situ adenocarcinoma