OPEN Research Support
head

Specialist registrar
Louise Raunkilde Larsen
Department of Oncology, Lillebaelt Hospital, Vejle


Projekt styring
Projekt status    Sampling ongoing
 
Data indsamlingsdatoer
Start 01.03.2016  
Slut 31.12.2024  
 



A randomized investigation of side effects to FOLFOXIRI in combination with tocotrienol or placebo as first line treatment of metastatic colorectal cancer

Short summary

Treatment with FOLFOXIRI (5-fluorouracil, oxaliplatin and irinotecan) can be an effective treatment of metastatic colorectal cancer, but it has serious side effects, which may require hospitalization. The aim of this study is to investigate, whether the addition of tocotrienol can reduce the side effects to FOLFOXIRI otherwise leading to hospitalization. The study is randomised and double blinded. 


Rationale

Colorectal cancer is a serious disease with significant morbidity and mortality. The median survival is 20-22 months - though with individual differences. The combination of 5-fluorouracil, oxaliplatin and irinotecan appears to be an effective first-line treatment for patients with metastatic colorectal cancer in good performance status. A limiting factor in treatment with triplet chemotherapy is toxicity. Depending on the grade of toxicity, it can lead to dose reduction, delay or even discontinuation of the treatment. Studies have shown, that vitamin E (tocotrienol) may have neuroprotective, anti-cancer and anti-inflammatory effects. By combining FOLFOXIRI with tocotrienol or placebo, we wish to investigate whether tocotrienol with its properties, can reduce the serious side effects that would lead to hospitalization.


Description of the cohort

Patients with metastatic colorectal cancer, age 18-75 years, who are about to receive first line treatment for metastatic disease, including potentially and non-resectable disease.


Data and biological material

Side effects

Radiologic evaluation before, during and after chemotherapy.

Clinical follow up

Quality of life

A biobank will be established at Vejle Hospital for translational research. Blood sample will be drawn before start of treatment, at each cycle of chemotherapy and each follow-up visit.


Collaborating researchers and departments

Institutions willing to comply with the protocol are welcome to participate.