NCT04245865

Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer

Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer. A Randomized Phase II Marker Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Vejle Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This double blind, randomized phase II trial will investigate whether the addition of tocotrienol will improve the effect and lower the toxicity of standard chemotherapy and bevacizumab. Half of the patients will receive tocotrienol and the other half placebo. Treatment is planned for a period of maximum six months and will be discontinued earlier in case of progression or unacceptable toxicity.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Fluorouracil	2800 mg/m2 iv
DRUG	Calcium folinate	400 mg/m2 iv
DRUG	Oxaliplatin	85 mg/m2 iv
DRUG	Bevacizumab	5 mg/kg OR 7.5 mg/kg iv
DRUG	Capecitabine	2000 mg/m2 orally daily for two weeks
DIETARY_SUPPLEMENT	Tocotrienol	300 mg orally x 3 daily
OTHER	Placebo	Placebo orally x 3 daily

Timeline

• Start date: 2020-06-26
• Primary completion: 2025-03-31
• Completion: 2026-12-01
• First posted: 2020-01-29
• Last updated: 2026-04-03

Locations

1 site across 1 country: Denmark