Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLithuanian University of Health Sciences
About this trial
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
Eligibility criteria
Qualifiers
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),
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Radiotherapy 50 Gy
- Fluorouracil/folic acid
- Chemotherapy in regimen with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4)
- Radiotherapy 50 Gy
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov