Actively Recruiting
Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer
Led by Lithuanian University of Health Sciences · Updated on 2022-05-18
250
Participants Needed
1
Research Sites
626 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with rectal adenocarcinoma
- Measurable tumor size by imaging
- General condition with ECOG score 0-2
- Clinical stage II or III rectal tumor confirmed by pelvic MRI and endorectal ultrasound
- No long-term disease spread confirmed by thorax and abdomen CT scans
- Tumor detected 0-15 cm from the anus by preoperative proctoscopy
- Blood tests within 28 days before treatment start showing neutrophils > 1.5x10^9/l, platelets > 100x10^9/l, hemoglobin > 80 g/l, liver enzymes (AST, ALT) not more than 3 times the upper limit, and creatinine up to 1.5 times normal
- Negative pregnancy test for women of childbearing potential
- Signed informed consent form
You will not qualify if you...
- Signs of intestinal obstruction at treatment start
- Previous radiation therapy to lower abdomen
- Other tumors within the past five years
- Pregnant or breastfeeding women
- Men and women of childbearing potential not agreeing to use adequate contraception
- Co-morbidities making the patient unsuitable or interfering with safety and toxicity assessment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Rita Ambraziene
Kaunas, Lithuania, 45304
Actively Recruiting
Research Team
R
Rita Ambraziene
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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