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

• Status: Active, not recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vejle Hospital
• Treatments: Calcium, Dietary; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin; Tocopherols; Tocotrienols; Vitamin E

Criteria

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