Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX
Conditions
Brief 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
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
RADIATIONRadiotherapy 50 Gy
Radiotherapy 50 Gy 5 radiations per week of 2 Gy for 5 weeks
DRUGFluorouracil/folic acid
Fluorouracil 400 mg/m² D1-4 and folic acid 20mg/m2 D1-4 the first and fifth weeks of radiotherapy
DRUGChemotherapy 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).
Sponsors
Lithuanian University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival | 3 year | To compare the 3-year disease-free survival between the investigational arm and the control arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 7 year | Overall survival will be defined as the time from randomisation to the time of occurrence of the first death regardless to its cause. Patients alive at the time of analysis will be censored at the date of the last follow up. |
Countries
Lithuania
Contacts
Primary ContactRita Ambraziene
Outcome results
None listed