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FOLFOX (oxaliplatin +leucovorin+ 5FU) +bevacizumab+ metastases resection

FOLFIRI (irinotecan+leucovorin+5FU) +bevacizumab +metastases resection

Surgery of colorectal cancer metastases will be proceeded after 3 to 6 cycles of chemotherapy ( folfox or folfiri) + bevacizumab .

Metastases resection

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

5 FU

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

Marc Van den Eynde, MD

Javier Carrasco, MD PhD

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 Comparing Pathological Responses Observed on Colorectal Cancer Metastases Resected After Preoperative Bevacizumab With FOLFOX or FOLFIRI.

Randomized Phase 2 Study Comparing Pathological Responses on Colorectal Cancer Metastases After Preoperative Treatment Combining Bevacizumab With FOLFOX or FOLFIRI

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

The overall survival will be analyzed at the end of the study (3 years of recruitment and one years of follow-up)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study Comparing Pathological Responses Observed on Colorectal Cancer Metastases Resected After Preoperative Bevacizumab With FOLFOX or FOLFIRI.	NCT01858649	Metastatic Colo...	Metastases rese... Bevacizumab 5 FU Oxaliplatin Irinotecan	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Comparing Pathological Responses Observed on Colorectal Cancer Metastases Resected After Preoperative Bevacizumab With FOLFOX or FOLFIRI.	NCT01858649	Metastatic Colo...	Metastases rese... Bevacizumab 5 FU Oxaliplatin Irinotecan	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Spots Global Cancer Trial Database for metastases resection