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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Max. 4 months
Max. 4 months
Max. 6 months
Department of Oncology, Vejle Hospital
Vejle, Denmark
Time to first serious adverse event
Time frame: 6 months after the last patient has finished chemotherapy
Number of non-planned hospitalizations calculated from date of first treatment until 1 month after completed chemotherapy
Time frame: 6 months after the last patient has finished chemotherapy
Duration of non-planned hospitalizations calculated from date of first treatment until 1 month after completed chemotherapy
Time frame: 6 months after the last patient has finished chemotherapy
Death during treatment calculated from date of first treatment until 1 month after completed chemotherapy
Time frame: 6 months after the last patient has finished chemotherapy
Response rate
Time frame: 6 months after the last patient has finished chemotherapy
Progression free survival
Time frame: 6 months after the last patient has finished chemotherapy
Overall survival
Time frame: 6 months after the last patient has finished chemotherapy
Number of patients with treatment related adverse events as assessed by CTCAE v.4.0
Time frame: 6 months after the last patient has finished chemotherapy
Quality of life as measured by combined questionnaire consisting of EORTC QLQ-C30 and CR29
Time frame: 6 months after the last patient has finished chemotherapy
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Max. 6 months
Max. 2 years or at the discretion of the investigator
Max. 2 years or at the discretion of the investigator
Resection rate
Time frame: 6 months after the last patient has finished chemotherapy