NCT03426904Active, not recruitingPhase 3
Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer
Neoadjuvant Chemotherapy for Non-metastatic Locally Advanced Colon Cancer: A Prospective Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
The main cause of recurrence after surgical treatment of colon cancer is distant metastasis. Neoadjuvant chemotherapy has potential benefits of improving the effectiveness of chemotherapy. Preoperative chemotherapy may eradicate microscopic metastatic cancer cells earlier than adjuvant chemotherapy, reduce cancer cell spillage during surgery, and lessen the invasiveness of surgical resection. This randomized multicenter phase III trial is assessing whether preoperative chemotherapy improves oncologic outcomes of patients with locally advanced colon cancer.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 708 (estimated)
- First submitted
- 23 Jan 2018
- Start date
- 23 Oct 2020
- Primary completion date
- 28 Dec 2028
- Lead sponsor
- Kyungpook National University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT03426904
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 708
- From 23 Oct 2020 to the primary completion date, 28 Dec 2028
- 4 sites 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.
Other illness
- Rectal cancer : 15 cm or less from the anal verge
- Complicated colon cancer (complete obstruction, perforation, bleeding)
- Metastatic colon cancer
- Known hypersensitivity reaction to any of the components of study treatments
- Inflammatory bowel disease
- Clinically relevant coronary artery disease or history of myocardial infarction in the last 6 months, high risk of uncontrolled arrhythmia
- Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
- Any significant disease which, in the investigator's opinion, would exclude the patient from the study
Lab values
- Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
Age
- Age \> 70 years and \< 18 years
Other
- Hereditary nonpolyposis colorectal cancerHNPCC, familial Adenomatous Polyposis
- Pregnancy or breast-feeding period
- Serious non-healing wound or bone fracture
Who the study is looking for
- Pathologically confirmed colon adenocarcinoma (\> 15 cm from the anal verge)
- Radiologic T3/T4 and high risk features by CT scan
- No metastasis on CT or PET(positron emission computed tomography)
- Age ≥ 18 and ≤ 70 years
- ECOG (Eastern Cooperative Oncology Group) performance status 0-1
- No history of colorectal cancer within 5 years
- No history of chemotherapy
- Patients with childbearing potential should use effective contraception during the study and the following 6 months
- Adequate bone marrow function : white blood cell count of 2 x 109/L or more with neutrophils of1.5 x 109/L or more, platelet count of 100 x 109/L or more, hemoglobin of 9 g/dL (5,6 mmol/l) or more
- Adequate hepatobiliary function : total bilirubin of 0.4 mg/dl or less, ASAT (aspartate aminotransferase) and ALAT (alanine aminotransferase) of 2.5 x ULN (upper limits of normal) or less, Alkaline phosphatase of 1.5 x ULN or less
- Adequate renal function : GFR (Glomerular Filtration Rate) \> 50ml/min by Wright or Cockcroft formula
- Signed written informed consent obtained prior to any study specific screening procedures
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic Univ. of Korea St. Vincent's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.