Neoadjuvant chemotherapy versus standard treatment in patients with locally advanced colon cancer (NeoCol)

Prior treatment

• 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.

• Histologically verified locally advanced T3 (ETI > 5 mm) or T4 colon cancer assessed by CT scan. • Age ≥ 18 years • PS 0-2. • Hematology ANC ≥1.5x109/l. Thrombocytes ≥ 100x109/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.