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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
83
Department of Oncology, Vejle Hospital
Vejle, Denmark
The rate of progression free patients at six months
Time frame: Six months after enrollment of the last patient
Time to first serious adverse event according to CTCAE 5.0
CTCAE=Common Terminology Criteria for Adverse Events
Time frame: Six months after enrollment of the last patient
Response rate as measured by RECIST 1.1
RECIST=Response evaluation criteria in solid tumors
Time frame: Six months after enrollment of the last patient
Overall survival
Time frame: 12 months after enrollment of the last patient
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5 mg/kg OR 7.5 mg/kg iv
2000 mg/m2 orally daily for two weeks
300 mg orally x 3 daily
Placebo orally x 3 daily