The study is designed to analyze the pathological tumor response on resected colorectal cancer metastases after preoperative treatment with bevacizumab combined with FOLFOX or FOLFIRI regimen in a prospective cohort and to correlate this response with patient's outcome.
This is a phase II , openlabel, randomized study in patients with confirmed diagnosis of resectable metastatic colorectal adenocarcinoma , who have not received prior chemotherapy for their metastatic disease. The study is designed to compare pathological responses observed after pre-operative chemotherapy bevacizumab with FOLFOX or FOLFIRI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Surgery of colorectal cancer metastases will be proceeded after 3 to 6 cycles of chemotherapy ( folfox or folfiri) + bevacizumab .
Bevacizumab 5 mg/kg in 100 ml NaCl 0.9% IV infusion 3 to 5 cycles. No bevacizumab for ultimate cycle .
Leucovorin L (levoleucovorin) 200 mg/m2 (or folinic acid 400 mg/m²) in 250 ml glucose 5%, IV infusion 3 to 6 cycles 5-FU bolus 400 mg/m2, IV bolus 3 to 6 cycles 5-FU continuous infusion 2400 mg/m2, 46-hour cont. IV infusion 3 to 6 cycles
Clinique Saint Luc
Bouge, Belgium
CHIREC
Brussels, Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium
Grand Hopital de Charleroi
Charleroi, Belgium
the major pathological response rate
This is at the surgery time. The metastases resection must be process after 6 cycles of randomized chemotherapy + target therapy. It depend but it will be normally 3 months after patient inclusion in the study
Time frame: After surgery (Metastases resection-average 3 months)
Progression free survival
Time frame: at 6 months and at 12 months after randomization
Overall Survival
The overall survival will be analyzed at the end of the study (3 years of recruitment and one years of follow-up)
Time frame: At the end of the study
Clinical Response Rate
Time frame: At time of surgery - average 3 months
Metabolic Response Rate
Time frame: At time of surgery - Average 3 months
Post operative complication
Time frame: One month after surgery
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oxaliplatin 85 mg/m² in 150 ml NaCl 0.9%, IV infusion 3 to 6 cycles
Irinotecan 180 mg/m² in 150 ml NaCl 0.9%, IV infusion 3 to 6 cycles
AZ Groeninge
Kortrijk, Belgium
Centre Hospitalier Jolimont Lobbes
La Louvière, Belgium
CHC Liège clinique Saint Joseph
Liège, Belgium
CHU liège (Sart Timan)
Liège, Belgium
Clinique Maternité Saint Elisabeth
Namur, Belgium
Clinique Saint Pierre Ottignies
Ottignies, Belgium
...and 1 more locations