NCT05378919RecruitingPhase 2
Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer
Evaluation and Comparison of the Efficacy of a New Standard Pre-operative Chemotherapy for Stage II and III Colorectal Cancer According to the FOLFOX4 Regimen With Routine Chemoradiation Therapy
Source: ClinicalTrials.gov · Last updated 18 May 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 8 May 2022
- Start date
- 1 Jun 2015
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Lithuanian University of Health Sciences
- Diseases
- Colorectal cancer
- NCT number
- NCT05378919
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 250
- From 1 Jun 2015 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous lower abdominal radiation therapy;
Other
- patients with signs of intestinal obstruction at the start of treatment;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rita Ambraziene Coordinator of this site? Confirm its status | Kaunas | Lithuania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.