Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer Clinical Trial
Official title:
Open, Randomized, Controlled, Multicenter Phase III Study Comparing 5FU/ FA Plus Irinotecan Plus Cetuximab Versus 5FU/FA Plus Irinotecan as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer
Drugs used against cancer work in different ways to stop the growth of tumor cells, either
by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as
cetuximab, can block tumor growth in different ways. Giving combination chemotherapy
together with cetuximab as first treatment after diagnosis of a metastatic colorectal cancer
('1st-line' treatment) may improve the treatment efficacy. However, it is not yet known
whether giving combination chemotherapy together with cetuximab is more effective than
combination chemotherapy alone. This open-label trial investigates the effectiveness of
cetuximab in combination with a standard and effective chemotherapy (5-Fluorouracil
(5FU)/Folinic acid (FA) plus irinotecan) for metastatic colorectal cancer in first-line
setting, compared to the same chemotherapy alone on patient expressing the epidermal growth
factor (EGF) receptor.
Patients expressing this EGF Receptor will be randomly assign in one of the 2 groups to
either receive the combination chemotherapy alone or with cetuximab (open-label study) and
will then be treated until progression of the disease or unacceptable toxicity occur.
Regular efficacy assessments (every 8 weeks) based on imaging will be performed throughout
the study together with regular safety assessments (e.g. safety labs). An independent Safety
Board of experts will also monitor safety data.
After participant discontinuation from the trial, regular updates on further treatments and
survival status will be requested from the investigator.
The entire study (from the first patient entering the study to the last collect of follow-up
information) is 4-5 years long.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment