Spots Global Cancer Trial Database for Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer

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Trial Identification

Brief Title: 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

Study ID: NCT03053544

Conditions

Rectal Neoplasm Carcinoma in Situ Adenocarcinoma

Interventions

Metformin

Study Description

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.