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ACTIVE NOT RECRUITING
NCT04245865
PHASE2

Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer

Sponsor: Vejle Hospital

View on ClinicalTrials.gov

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

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

Locations (1)

Department of Oncology, Vejle Hospital

Vejle, Denmark