NCT03053544

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Neoplasm Carcinoma in Situ Adenocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-12-08
• Primary completion: 2019-06-26
• Completion: 2019-06-26
• First posted: 2017-02-15
• Last updated: 2019-09-27

Locations

1 site across 1 country: Canada