Comparing neoadjuvant chemotherapy and standard therapy for rectal cancer

Evaluation and Comparison of the Efficacy of a New Standard Pre-operative Chemotherapy for Stage II and III Colorectal Cancer According to the FOLFOX4 Regimen With Routine Chemoradiation Therapy

This study is testing whether a new type of chemotherapy before surgery can work better than the usual treatment for people with locally advanced rectal cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Lithuanian University of Health Sciences (Academic / other)
• Drugs / interventions: radiation, chemotherapy
• Locations: 1 site (Kaunas)
• Trial ID: NCT05378919 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with stage II or III rectal adenocarcinoma who meet specific health criteria and have measurable tumor sizes.

Not a fit: Patients with signs of intestinal obstruction or those with advanced disease spread may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective preoperative treatment option for patients with locally advanced rectal cancer.

How similar studies have performed: Other studies have shown promising results with neoadjuvant chemotherapy approaches, suggesting potential for success in this area.

Eligibility 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.

Where this trial is running

Kaunas

• Rita Ambraziene — Kaunas, Lithuania (Recruiting)

Study contacts

• Study coordinator: Rita Ambraziene

Conditions Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX