Overview

Phase II, Multicenter, Open-label, Randomized Study evaluating neoadjuvant chemotherapy (FOLFOX4) in patients with stage II and III colorectal cancer with standard chemoradiation Defined by Magnetic Resonance Imaging

Eligibility

Inclusion Criteria:

• diagnosed with rectal adenocarcinoma;
• radiologically measurable tumor size;
• general condition (ECOG 0-2 points);
• stage II or III rectal tumor clinically (pelvic MRI and endorectal ultrasound),
• in the absence of long-term spread of the disease (confirmed by radiological examinations (computed tomography of the thorax and abdomen));
• during preoperative proctoscopy, the tumor is detected 0 -15 cm from the anus;
• Blood tests 28 days before the start of treatment:

        and general blood count: neutrophils greater than 1.5x10 9 / l, platelets greater than 100
        x 10 9 / l, Hemoglobin greater than 80 g / l, liver enzymes (Aspartate aminotransferase
        (AST/GOT), alanine aminotransferase (ALT/GPT) not more than 3 times upper limit), and renal
        function (creatinine up to 1.5 times the upper limit of normal) is normal; women of
        childbearing potential - negative pregnancy test;
        • A signed informed consent form.
        Exclusion Criteria:
          -  patients with signs of intestinal obstruction at the start of treatment;
          -  previous lower abdominal radiation therapy;
          -  other tumors over a five-year period;
          -  pregnant or breastfeeding women;
          -  men and women of childbearing potential who do not agree to use adequate
             contraception;
          -  Patient co-morbidities that would make the patient unsuitable for this study or
             significantly interfere with the assessment of safety and toxicity.