Side Effects to FOLFOXIRI + Tocotrienol/Placebo as First Line Treatment of Metastatic Colorectal Cancer

Inclusion criteria

• Histologically or cytologically verified colorectal adenocarcinoma.
• Patients to receive first line treatment of metastatic disease, including potentially resectable or non-resectable disease
• > 6 months without recurrence after end of adjuvant chemotherapy for radically treated stage II or III colorectal cancer
• Disease evaluable according to RECIST 1.1, but not necessarily measurable disease.
• Age 18-75 years
• Performance status (PS) 0-1. If age 71-75, then PS 0
• Life expectancy > 3 months
• Organ and bone marrow function as follows:

• Neutrophil count ≥ 1.5 x 10^9/L
• Thrombocytes ≥ 100 x 10^9/L
• Total bilirubin ≤ 1.5 x upper level of normal (ULN)
• Alanine transaminase (ALAT) ≤ 2.5 x ULN (or≤ 5 x ULN in case of liver metastases)
• Fertile women must present negative pregnancy test. Male (with a female fertile partner) as well as female patients must use secure contraceptives during and 6 months after end of treatment.
• Orally and written informed consent to treatment and biobank

Exclusion criteria

• Primarily resectable metastases
• Chemotherapy, radiotherapy or immunotherapy within 4 weeks
• Known neuropathy ≥ grade 2
• Serious competitive medical condition
• Other concurrent malignant disease other than non-melanoma skin cancer
• Previous serious and unexpected reactions to 5-fluorouracil, calcium folinate, oxaliplatin, irinotecan or capecitabine.
• Hypersensitivity to one or more of the active substances or auxilliary agents