Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer

Summary

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.

Conditions2

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