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Recruiting NCT05378919

Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer

Phase II Interventional Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiotherapy 50 Gy, Fluorouracil/folic acid, Chemotherapy in regimen with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4), Radiotherapy 50 Gy.
Who it may be relevant to
Registry conditions: Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Lithuania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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.

Interventions

  • Radiation Radiotherapy 50 Gy
    Radiotherapy 50 Gy 5 radiations per week of 2 Gy for 5 weeks
  • Drug Fluorouracil/folic acid
    Fluorouracil 400 mg/m² D1-4 and folic acid 20mg/m2 D1-4 the first and fifth weeks of radiotherapy
  • Drug Chemotherapy in regimen with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4)
    oxaliplatin: 85 mg/m² in 2 hours at D1; folinic acid: 100 mg/m² simultaneously in 2 hours at D1 and D2 during the Oxaliplatin; bolus 5-fluorouracil (5-FU) 400mg/m² D1+D2; infusion 5-fluorouracil (5-FU): 600 mg/m² continuous infusion during 22hours at D1 and D2, every 14 days during 42 months (8 cycles).
  • Radiation Radiotherapy 50 Gy
    Chemoradiotherapy 5 weeks (50 Grays (Gy), 2 Gy/session; 25 fractions) + fluorouracil/leucovorin 400 mg/m² 1-4 day the first and fifth weeks of radiotherapy. FOLOFX4 will be administrated for 8 cycles over a 16 week period. Patients will undergo re-staging within 6 weeks of their 8th cycle of FOLFOX. This will include MRI of the pelvis. If the reassessment reveals that there has been no disease progression compared to the pre-treatment evaluation and the patient remains a candidate for an R0 res

Primary outcome measures

  • disease-free survival [Time frame: 3 year]
Secondary outcome measures (1)
  • Overall survival [Time frame: 7 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Lithuania · 1 center
  • Rita Ambraziene — Kaunas

Identifiers

NCT: NCT05378919 · RECTUM2015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗