Colon CancerPhase 3NCT03426904
Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer
A Phase 3 study testing Neoadjuvant FOLFOX and Conventional adjuvant FOLFOX in people with Colon Cancer, run by Kyungpook National University Hospital at 4 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Neoadjuvant FOLFOX and Conventional adjuvant FOLFOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 708 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 23 Oct 2020to 28 Dec 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Age > 70 years and < 18 years
- 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
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- Hereditary nonpolyposis colorectal cancerHNPCC, familial Adenomatous Polyposis
- Clinically relevant coronary artery disease or history of myocardial infarction in the last 6 months, high risk of uncontrolled arrhythmia
- Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Pregnancy or breast-feeding period
- Serious non-healing wound or bone fracture
- 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
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Kyungpook National University Chilgok Hospital
Daegu, 41404
Chonnam National University Hwasun Hospital
Hwasun, Chonnam, 58128
Asan Medical Center
Seoul, 05505
The Catholic Univ. of Korea St. Vincent's Hospital
Suwon
About this study
Official title: Neoadjuvant Chemotherapy for Non-metastatic Locally Advanced Colon Cancer: A Prospective Multicenter Randomized Controlled Trial
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.
- Conditions
- Colon Cancer
- Being tested
- Neoadjuvant FOLFOX, Conventional adjuvant FOLFOX
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant FOLFOXDrug
4 cycles of FOLFOX neoadjuvant chemotherapy and 8 cycles of postoperative chemotherapy
Conventional adjuvant FOLFOXDrug
12 cycles of postoperative FOLFOX chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant FOLFOX | Experimental | 4 cycles of FOLFOX (Folinic acid, fluorouracil and oxaliplatin) neoadjuvant followed by surgery and 8 cycles of FOLFOX Receives: Drug: Neoadjuvant FOLFOX |
| Conventional adjuvant FOLFOX | Active comparator | surgery followed by 12 cycles of FOLFOX Receives: Drug: Conventional adjuvant FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse free survival after randomization
Measured: 3 years after randomization
Secondary outcomes (12)
Overall survival
Measured: 3 year after randomization
Radiological assessment of response to neoadjuvant treatment
Measured: 6 months after surgery
Pathological assessment of response to neoadjuvant treatment
Replacement of the tumor by fibrous or fibro-inflammatory granulation tissue
Measured: 1 months after surgery
Surgical complication
Measured: 60 days after surgery
Length of hospital stay
Measured: 60 days after surgery
Quality of life (EORTC QLQ-C30)
QLQ (quality of life questionnaire)
Measured: before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery
Quality of life (EORTC QLQ-C38)
Measured: before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery
Toxicity of chemotherapy
Toxicity : incidence of chemotherapy-related adverse events according to CTCAE (Common Terminology Criteria for Adverse Events) v4.0
Measured: 1 year
Incidence of completion of chemotherapy
Measured: 1 year
Accuracy of CT staging
Measured: 1 year
Total cycles of perioperative chemotherapy
Measured: 1 year
Pathological tumor stage
Colon cancer stage by AJCC 8th edition
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start23 Oct 2020
- Primary completion28 Dec 2028 (estimated)
- Study completion28 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 708 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gyu-Seog Choi, Kyungpook National University Hospital
- Investigators
- Soo Yeun Park, MD, Study director, Kyungpook National University Chilgok HospitalGyu-Seog Choi, MD, PhD, Principal investigator, Kyungpook National University Chilgok Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426904
- Sponsor's protocol ID
- KNUHCRC006
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2018
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy for Non-metastatic Locally Advanced Colon Cancer: A Prospective Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03426904
- Acronym / sponsor ID
- KNUHCRC006
- Conditions
- Colon Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 708 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 28 Dec 2028 (estimated)
- Study completion
- 28 Dec 2031 (estimated)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant FOLFOX | Experimental | Drug: Neoadjuvant FOLFOX4 cycles of FOLFOX (Folinic acid, fluorouracil and oxaliplatin) neoadjuvant followed by surgery and 8 cycles of FOLFOX |
| Conventional adjuvant FOLFOX | Active comparator | Drug: Conventional adjuvant FOLFOXsurgery followed by 12 cycles of FOLFOX |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- Age > 70 years and < 18 years
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant FOLFOX4 cycles of FOLFOX neoadjuvant chemotherapy and 8 cycles of postoperative chemotherapy | Drug | Neoadjuvant FOLFOX |
| Conventional adjuvant FOLFOX12 cycles of postoperative FOLFOX chemotherapy | Drug | Conventional adjuvant FOLFOX |
Primary outcome
Relapse free survival after randomization
Time frame: 3 years after randomization
12 secondary outcomes
Overall survival
Time frame: 3 year after randomization
Radiological assessment of response to neoadjuvant treatment
Time frame: 6 months after surgery
Pathological assessment of response to neoadjuvant treatment
Time frame: 1 months after surgery
Surgical complication
Time frame: 60 days after surgery
Length of hospital stay
Time frame: 60 days after surgery
Quality of life (EORTC QLQ-C30)
Time frame: before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery
Quality of life (EORTC QLQ-C38)
Time frame: before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery
Toxicity of chemotherapy
Time frame: 1 year
Incidence of completion of chemotherapy
Time frame: 1 year
Accuracy of CT staging
Time frame: 1 year
Total cycles of perioperative chemotherapy
Time frame: 1 year
Pathological tumor stage
Time frame: 1 month after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soo Yeun Park, MD study director
Kyungpook National University Chilgok Hospital
Gyu-Seog Choi, MD, PhD principal investigator
Kyungpook National University Chilgok Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neoadjuvant FOLFOX and Conventional adjuvant FOLFOX in people with Colon Cancer, run by Kyungpook National University Hospital at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse free survival after randomization (time frame: 3 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.