Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer
Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer
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.
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