NCT05378919 Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer
| NCT ID | NCT05378919 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Lithuanian University of Health Sciences |
| Condition | Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2015-06-01 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 250 participants in total. It began in 2015-06-01 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05378919 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05378919 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05378919 currently recruiting?
Yes, NCT05378919 is actively recruiting participants. Contact the research team at rita.ambraziene@gmail.com for enrollment information.
Where is the NCT05378919 trial being conducted?
This trial is being conducted at Kaunas, Lithuania.
Who is sponsoring the NCT05378919 clinical trial?
NCT05378919 is sponsored by Lithuanian University of Health Sciences. The trial plans to enroll 250 participants.
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