Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer (RECTUM2015)

  • End date
    Jun 1, 2027
  • participants needed
  • sponsor
    Lithuanian University of Health Sciences
Updated on 30 May 2022


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


This is a biomedical research, phase II, multicenter, open-label, randomized study, comparing neoadjuvant CT with FOLFOX4, versus immediate preoperative chemoradiotherapy (CRT), in patients with locally advanced rectal cancer. Randomization in a 1: 1 ratio, neoadjuvant chemotherapy or chemoradiation. The purpose of the study is to evaluate the efficacy, tolerability, and comparability of new standard preoperative chemotherapy with FOLFOX4 in patients with stage II and III colorectal cancer compared to routine chemoradiation.

Condition Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX
Treatment Radiotherapy 50 Gy, Fluorouracil/folic acid, Chemotherapy in regimen with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4)
Clinical Study IdentifierNCT05378919
SponsorLithuanian University of Health Sciences
Last Modified on30 May 2022


Yes No Not Sure

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
Patient co-morbidities that would make the patient unsuitable for this study or
significantly interfere with the assessment of safety and toxicity
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