Phase II Study Evaluating the Efficacy of the Combination of Metformin to Neoadjuvant Radiochemotherapy in the Treatment of Locally Advanced Rectal Cancer. (METCAP)

NCT02437656 Phase 2 COMPLETED

Metformin is an oral antidiabetic of the biguanide class derived from galega officinalis. Historical cohort of patients with diabetes have shown that diabetics on Metformin had a better chance of survival than diabetics not on Metformin. These observations have led to in vitro studies of metformin on cancer cells. It was thus demonstrated that Metformin has anti-proliferative properties. The aim of our study is to evaluate the efficacy of metformin in combination with neoadjuvant radiochemotherapy in the treatment of locally advanced rectal cancer.

Details

Lead sponsor	Centre Oscar Lambret
Phase	Phase 2
Status	COMPLETED
Enrolment	60
Start date	2015-05
Completion	2017-03

Conditions

• Rectal Cancer

Interventions

• Metformin

Primary outcomes

• The efficacy will be assessed on the operative specimen by the complete histological response rate (absence of tumor cells : pCR). — within 30 days after surgery

Countries

France