NCT02705300

Side Effects to FOLFOXIRI + Tocotrienol/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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Vejle Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan 165 mg/m2 iv	Max. 4 months
DRUG	Oxaliplatin 85 mg/m2 iv	Max. 4 months
DRUG	Calcium folinate 200 mg/m2 iv	Max. 6 months
DRUG	5-fluorouracil 3200 mg/m2	Max. 6 months
DIETARY_SUPPLEMENT	Tocotrienol	Max. 2 years or at the discretion of the investigator
DRUG	Placebo	Max. 2 years or at the discretion of the investigator

Timeline

• Start date: 2016-05-06
• Primary completion: 2019-08-01
• Completion: 2024-03-27
• First posted: 2016-03-10
• Last updated: 2024-08-29

Locations

1 site across 1 country: Denmark