This study will evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young patients with good performance status with unresectable metastatic colorectal cancer.
The combination of FOLFOXIRI plus cetuximab is reasonable safe regimen especially for patients with good performance status. The estimated benefit from the combination is greater than the possible risk, especially for the patients who will become resectable after treatment. It will be extremely interesting to evaluate the resectability rate of this specific group of patient with good performance status and unresectable disease when they are treated with all active chemotherapeutic agents and cetuximab
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Irinotecan will be administered at a dose of 150mg/m2 as a 30 min IV infusion on day 1
Leukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3
Oxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV
University Hospital of Crete
Heraklion, Greece
Objective Response Rate
Time frame: 2 months
Resectability rates
Time frame: Resectability at the end of treatment (4 or 6 months from the entry to the study)
Time to Tumor Progression
Time frame: 1 year
Overall Survival
Time frame: 1 year
Toxicity profile
Time frame: Toxicity assessment on each chemotherapy cycles (every 15 days)
Pharmacogenomic analysis
Time frame: During the treatment
Q-Twist analysis of Quality of life
Time frame: Quality of life assessment every 8 weeks
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5-FLUOROURACIL at the dose of 400mg/m2 as IV bolus and then, 600mg/m2 as a 22-hour continuous IV infusion, on days 2 and 3
Cetuximab will be administered at the dose of 500mg/m2 as a 2-hour infusion on day 1 at least one hour before chemotherapy