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About
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.
Enrollment
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Inclusion criteria
Histopathologically verified adenocarcinoma of the colon or rectum
Metastatic disease
Planned treatment with FOLFOX or capecitabine combined with bevacizumab
Evaluable disease according to RECIST 1.1
Performance status 0-2
Expected survival ≥ 3 months
Patient acceptance to collection of blood samples for translational research
Age ≥ 18 years
Contraception during and 6 months after last dose for women of childbearing potential (less than one year amenorrhea and not undergone hysterectomy, bilateral salpingectomy or bilateral oophorectomy) and for male patients with a fertile partner. Hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence is accepted.
Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
Urine dipstick for protein ≤ 2+, if the dipstick shows protein ≥ 2+, 24 hour urine testing must be performed and show protein contents ≤ 1g.
Written and orally informed consent
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
74 participants in 2 patient groups, including a placebo group
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Central trial contact
Natacha Trabjerg, MD
Data sourced from clinicaltrials.gov
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