Neoadjuvant Metformin in Association to Chemoradiotherapy for Locally Advanced Rectal Cancer (NEOMETRE)

This is an interventional treatment trial for Rectal Neoplasms focused on measuring Metformin, Rectal Cancer, Rectum, Radiotherapy, Capecitabine, Neoadjuvant, Adenocarcinoma, Carcinoma Read More

Inclusion Criteria:

• 18 years or older;
• biopsy proven poorly differentiated carcinoma or adenocarcinoma of the rectum;
• lesions located within 12 cm of the anal verge (from colonoscopy assessment);
• ability to tolerate oral treatment;
• locally advanced tumor, classified by the presence of positive regional lymph nodes or primary tumor invasion beyond the serosa (T3 or T4), assessed by MRI;
• eligibility for curative surgery (no distant metastasis or invasion of bony structures of the pelvis);
• Performance Status (PS) Eastern Cooperative Oncology Group (ECOG) 0-2;
• adequate hematologic functions (hemoglobin ≥ 10 g / dL [5.6 mmol / L]; neutrophil count ≥ 1,500 / mm3 and platelet count ≥ 100,000 / mm3), adequate renal function (serum creatinine less than 1.5 times the UNL) and adequate hepatic function (bilirubin less than 1.5 times the UNL; aspartate aminotransferase and alanine aminotransferase less than 2.5 times the UNL);

Exclusion Criteria:

• known hypersensitivity to metformin or its excipients;
• squamous carcinomas of the rectum or anal canal;
• chronic treatment with corticosteroids or other immunosuppressive agents;
• treatment with oral antidiabetic products;
• distant metastasis at diagnosis or tumor invasion of pelvic bone structures that may proscribe curative intent surgery;
• chronic or acute infections;
• use of drugs under study up to four weeks prior to randomization;
• pregnant or nursing patients;
• prior radiotherapy to the pelvic region;
• myocardial infarction up to six months prior to randomization, or uncontrolled ischemic heart disease;
• congestive heart insufficiency New York Heart Association (NYHA) III-IV.