A Randomized Investigation of Side Effects to FOLFOXIRI in Combination With Tocotrienol or Placebo as First Line Treatment of Metastatic Colorectal Cancer
A Randomized Investigation of Side Effects to FOLFOXIRI in Combination With Tocotrienol or Placebo as First Line Treatment of Metastatic Colorectal Cancer
Treatment with FOLFOXIRI (5-fluorouracil, oxaliplatin, irinotecan) can be effective, but it has serious side effects, which may require hospitalization.
The purpose of this study is to investigate whether the addition of tocotrienol can reduce the side effects to FOLFOXIRI otherwise leading to hospitalization.
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:
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: