Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer

  • STATUS
    Recruiting
  • End date
    Feb 28, 2026
  • participants needed
    560
  • sponsor
    Kyungpook National University Hospital
Updated on 7 October 2022
platelet count
metastasis
folfox regimen
adenocarcinoma
adjuvant chemotherapy
adenocarcinoma of colon

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. 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.

Details
Condition Colon Cancer
Treatment Neoadjuvant FOLFOX, Conventional adjuvant FOLFOX
Clinical Study IdentifierNCT03426904
SponsorKyungpook National University Hospital
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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