Combination of Metformin to Neoadjuvant Radiochemotherapy in the Treatment of Locally Advanced Re… (NCT02437656) | Clinical Trial Compass
CompletedPhase 2
Combination of Metformin to Neoadjuvant Radiochemotherapy in the Treatment of Locally Advanced Rectal Cancer.
France60 participantsStarted 2015-05
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient with an adenocarcinoma of the low or middle rectum.
✓. T3 or T4 stage (T evaluated by MRI and / or echo-endoscopy).
✓. Absence of distant metastasis.
✓. Patient requiring a radiochemotherapy.
✓. Correct hematological conditions : Neutrophils ≥ 1500 G / L, platelets ≥ 100 000 G / L.
✓. Age ≥ 18 years
✓. Performance status (WHO) ≤ 2
✓. Lactatemia ≤ Higher standard of the sampling laboratory.
Exclusion criteria
✕. Other histologies such as squamous cell carcinoma, neuroendocrine tumors, melanomas, etc.
✕. History of lactic acidosis.
✕. Any diabetes (According to the WHO definition : fasting plasma glucose (FPG) \> 1.26 g / L-1).
What they're measuring
1
The efficacy will be assessed on the operative specimen by the complete histological response rate (absence of tumor cells : pCR).