Status:
RECRUITING
Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer
Lead Sponsor:
Lithuanian University of Health Sciences
Conditions:
Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 R...
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 local...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05378919
Start Date
June 1 2015
End Date
June 1 2027
Last Update
May 18 2022
Active Locations (1)
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1
Rita Ambraziene
Kaunas, Lithuania, 45304