A randomized investigation of side effects to FOLFOXIRI in combination with tocotrienol or placebo as first line treatment of metastatic colorectal cancer.

Vejle Hospital0 个研究点目标入组 70 人开始时间: 2016年1月4日最近更新: 2024年7月8日

试验速览

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•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 year
•PS 0-1. If age 71-75, then PS 0
•Life expectancy > 3 months
•Organ and bone marrow function as follows:
•oNeutrofile count = 1.5 x 10^9/L
•oThrombocytes = 100 x 10^9/L
•oTotal bilirubin = 1.5 x ULN
•oALAT = 2.5 x ULN (or= 5 x ULN in case of liver metastases)
•Fertile women must present negative pregnancy test. Male patients (with a female fertile partner) as well as women must use secure contraceptives during and 6 months after end of treatment.
•Orally and written informed consent to treatment and biobank
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•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-FU, calcium folinate, oxaliplatin, irinotecan or capecitabine.
•Hypersensitivity to one or more of the active substances or auxilliary agents

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