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Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer
Sponsor: Vejle Hospital
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.
Official title: Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer. A Randomized Phase II Marker Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
83
Start Date
2020-06-26
Completion Date
2026-12
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
Fluorouracil
2800 mg/m2 iv
Calcium folinate
400 mg/m2 iv
Oxaliplatin
85 mg/m2 iv
Bevacizumab
5 mg/kg OR 7.5 mg/kg iv
Capecitabine
2000 mg/m2 orally daily for two weeks
Tocotrienol
300 mg orally x 3 daily
Placebo
Placebo orally x 3 daily
Locations (1)
Department of Oncology, Vejle Hospital
Vejle, Denmark