drugset / Trial / NCT02705300

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

NCT02705300 ↗

Phase 2 Completed 70 enrolled Vejle Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2016-05-06
Primary completion
2019-08
Completion
2024-03-27

Drugs

EvaluationDrugModalityDoseRoute
Background Calcium folinate Unknown 200 mg/m2 Intravenous
Background Irinotecan Small molecule 165 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 3200 mg/m2 Other

Indications