MedTrace Logo

Side Effects to FOLFOXIRI + Tocotrienol/Placebo as First Line Treatment of Metastatic Colorectal Cancer

NCT02705300 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-08-29

No results posted yet for this study

Summary

Treatment with FOLFOXIRI (5-fluorouracil, oxaliplatin, irinotecan) can be effective, but it has serious side effects, which may require hospitalization.

The purpose of this study is to investigate whether the addition of tocotrienol can reduce the side effects to FOLFOXIRI otherwise leading to hospitalization.

Conditions

Interventions

DRUG

Irinotecan 165 mg/m2 iv

Max. 4 months

DRUG

Oxaliplatin 85 mg/m2 iv

Max. 4 months

DRUG

Calcium folinate 200 mg/m2 iv

Max. 6 months

DRUG

5-fluorouracil 3200 mg/m2

Max. 6 months

DIETARY_SUPPLEMENT

Tocotrienol

Max. 2 years or at the discretion of the investigator

DRUG

Placebo

Max. 2 years or at the discretion of the investigator

Sponsors & Collaborators

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Lars H Jensen, PhD · Department of Oncology, Vejle Hospital

  • Louise R Larsen, MD · Department of Oncology, Vejle Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-06
Primary Completion
2019-08-31
Completion
2024-03-27

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02705300 on ClinicalTrials.gov