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Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer

NCT04245865 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2026-04-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Torben F Hansen, MD, PhD · Department of Oncology, Vejle Hospital - University Hospital of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-26
Primary Completion
2025-03-31
Completion
2026-12-31

Countries

  • Denmark

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04245865 on ClinicalTrials.gov