Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer

Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer

The purpose of this study is to compare 3 cycles of neoadjuvant (preoperative) chemotherapy + operation with the standard treatment of locally advanced colon cancer, which is operation + 8 cycles of (adjuvant) chemotherapy.

Patients receiving neoadjuvant chemotherapy may not need adjuvant chemotherapy after the operation and, if this is the case, they will be spared of 5 cycles of chemotherapy.

Inclusion Criteria:

• Histologically verified locally advanced T3 (ETI > 5 mm) or T4 colon cancer assessed by CT scan.
• Age ≥ 18 years
• PS 0-2.
• Hematology ANC ≥1.5x10^9/l. Thrombocytes ≥ 100x10^9/l.
• Biochemistry Bilirubinemia ≤ 3 x upper normal level. ALAT ≤ 5 x upper normal value
• Consent to translational research
• Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment.
• Written and orally informed consent.

Exclusion Criteria:

• Patients with distant metastases.
• Acute operation
• Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before inclusion.
• Active, serious infection or other serious disease.
• Peripheral neuropathy NCI grade > 1
• Other malignant disease within 5 years prior to study enrollment, except basocellular or squamous skin cancer and carcinoma in situ cervicis uteri.
• Other investigational treatment within 30 days prior to treatment start.
• Hypersensitivity to one or more of the active or auxiliary substances.