Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer

• Status: Recruiting
• Trial end date: 2027-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lithuanian University of Health Sciences
• Treatments: Fluorouracil; Folic Acid; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

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.