Comparing neoadjuvant chemotherapy and standard therapy for rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II, multicenter, open-label, randomized study evaluates the effectiveness of neoadjuvant chemotherapy using FOLFOX4 compared to standard preoperative chemoradiotherapy in patients with locally advanced rectal cancer. Participants will be randomly assigned to receive either neoadjuvant chemotherapy or immediate preoperative chemoradiation. The study aims to assess the efficacy, tolerability, and overall comparability of these two treatment approaches in patients diagnosed with stage II and III colorectal cancer. The evaluation will be based on radiological measurements and patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rita Ambraziene
  Kaunas, Lithuania Recruiting

Study contacts

• Study coordinator: Rita Ambraziene
• Email: rita.ambraziene@gmail.com
• Phone: +37037326196

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.