When you're facing a diagnosis of locally advanced rectal cancer, the treatment path is intense: weeks of chemotherapy and radiation to shrink the tumor before surgery. This study asked a simple but important question: could adding a common, well-known diabetes pill make that pre-surgery treatment work better? The drug is called metformin. Doctors had noticed that people with diabetes who took metformin seemed to have better survival odds, and lab studies showed the drug could slow cancer cell growth. So, they designed a trial to test it in people with this specific cancer. In the study, patients took metformin pills alongside their standard pre-surgery chemo and radiation. The goal was to see if this combination led to what doctors call a 'complete pathological response'—meaning when the surgeon removed the tissue, no cancer cells could be found under the microscope. Finding no cancer cells after this intense treatment is a very good sign. The study enrolled 60 people to see if this accessible, repurposed drug could offer them a better chance.
Could a common diabetes drug help people with rectal cancer respond better to treatment?
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What this means for you:
A diabetes drug was tested to see if it could boost pre-surgery treatment for rectal cancer. What this means for you:
A diabetes drug was tested to see if it could boost pre-surgery treatment for rectal cancer. View Original Abstract ↓
Status: COMPLETED | Phase: PHASE2
Condition(s): Rectal Cancer
Intervention(s): Metformin (DRUG)
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.
Detailed: Patients eligible for the trial and having signed their consent to participate will undergo a dosimetric scan at baseline. 48 hours later (minimum), a Metformin therapy will be started at a dosage of 850 mg 2 times / day ( = 1700 mg / day). Seven days later (minimum) and up to 48 hours before surgery, the dosage of Metformin will be increased to 850 mg 3 times / day ( = 2550 mg / day). This very same day (J10), patients will start a radiochemotherapy. For 5 weeks, 5 days out of 7, patients will receive 800 mg/m² of Capecitabine 2 times / day (on morning and evening) ( = 1600 mg / m² / day) and a 3D irradiation or an Intensity-Modulated Radiation Therapy (IMRT) of a total dose of 50 Gy (5 sessions of 2 Gy per week). 6 to 8 weeks after completion of the chemoradiotherapy, surgery will be sch
Primary Outcome(s): The efficacy will be assessed on the operative specimen by the complete histological response rate (absence of tumor cells : pCR).
Enrollment: 60 (ACTUAL)
Lead Sponsor: Centre Oscar Lambret
Start: 2015-05 | Primary Completion: 2017-03