Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer

Sponsor
Vejle Hospital
Study ID
NCT04245865
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jan 29, 2020
Start date
Jun 26, 2020
Status verified
Mar 2026
Primary completion
Mar 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
83 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A, standard treatment + tocotrienol
    Fluorouracil + calcium folinate + oxaliplatin + bevacizumab + tocotrienol OR capecitabine + bevacizumab + tocotrienol
  • Placebo Comparator: Arm B, standard treatment + placebo
    Fluorouracil + calcium folinate + oxaliplatin + bevacizumab + placebo OR capecitabine + bevacizumab + placebo

Primary Outcome Measure

The rate of progression free patients at six months [ Time Frame: Six months after enrollment of the last patient ]

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