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A randomized phase II study to investigate the deepness of response of FOLFOXIRI plus cetuximab (Erbitux) versus FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors: DEEPER

ABSTRACT: Interventions: FOLFOXIRI+Bevacizumab (until 12 courses) 5-FU+Levofolinate+Bevacizumab (after 13 courses) Bevacizumab 5mg/kg/bi-weekly Irinotecan 150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 2400mg/m2/bi-weekly FOLFOXIRI+Cetuximab (until 12 courses) 5-FU+Levofolinate+etuximab (after 13 courses) Cetuximab (first time) 400 mg/m2/week Cetuximab (after 2nd time) 250 mg/m2/week Irinotecan 150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 2400mg/m2/bi-weekly Primary outcome(s): DpR: Deepness of Response Study Design: Parallel Randomized

DISEASE(S): Nras Exon 2,3,4),Measurable Advanced Colorectal Cancer With Ras Wild-type ( Kras Exon 2,3,4

PROVIDER: 2633522 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Research on biomarkers in ‘A randomized phase II study to investigate the deepness of response of FOLFOXIRI plus cetuximab (Erbitux) versus FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors&quot

Project description:Interventions: FOLFOXIRI+/-Bevacizumab (To 12 courses) 5-FU+Levofolinate+/-Bevacizumab (From 13 courses) Bevacizumab 5mg/kg/bi-weekly Irinotecan 150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 2400mg/m2/bi-weekly FOLFOXIRI+/-Cetuximab (To 12 courses) 5-FU+Levofolinate+/-Cetuximab (From 13 courses) Cetuximab (first time) 400 mg/m2/week Cetuximab (after 2nd time) 250 mg/m2/week Irinotecan 150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 2400mg/m2/bi-weekly Primary outcome(s): Correlation between the reported biomarkers or outcome and clinical response. Study Design: Parallel Randomized

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JACCRO CC-11 study

Project description:Interventions: FOLFOXIRI+/-bevacizumab (To 12 courses), 5-FU+Levofolinate+/-bevacizumab (From 13 courses) given on day 1 every 2 weeks, until disease progression or unmanageable toxicity. bevacizumab 5mg/kg/bi-weekly Irinotecan 150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 2400mg/m2/bi-weekly Primary outcome(s): Response Rate Study Design: single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose

| 2613998 | ecrin-mdr-crc

Phase II study of first-line treatment by FOLFOXIRI+bevacizumab in patients with RAS mutant-type metastatic colorectal cancer

Project description:Interventions: FOLFOXIRI +/- bevacizumab (Until 12 course) 5-FU + levoforinate +/- bevacitumab (After 13 course) bevacizumab 5mg/Kg/bi-weekly Irinotecan 150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 2400mg/m2/bi-weekly Primary outcome(s): Response Rate Study Design: Single arm Non-randomized

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Phase I study of 5-FU + Oxaliplatin + Irinotecan + Levofolinate + Panitumumab as the first-line therapy in patients with KRAS or RAS wild-type metastatic colorectal cancer

Project description:Interventions: FOLFOXIRI+Panitumumab (Until 12 courses) Panitumumab 6mg/kg/bi-weekly Irinotecan 165-125mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 3200mg/m2/bi-weekly Primary outcome(s): Recommended Dose Study Design: Single arm Non-randomized

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Phase I study of FOLFOXIRI+cetuximab in patients with RAS wild-type unresectable colorectal cancer

Project description:Interventions: FOLFOXIRI+cetuximab (until 12 courses) Cetuximab 400mg/m2/weekly (initial dose) 250mg/m2/weekly (maintenance) Irinotecan 100-150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly 5-FU 2400mg/m2/bi-weekly Primary outcome(s): Recommended dose Study Design: Single arm Non-randomized

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Project description:Interventions: first line chemotherpy FOLFIRI+Cetuximab (Cetuximab 500mg/m2/bi-week CPT-11 150mg/m2/bi-week l-LV 200mg/m2/bi-week 5-FU/bolus 400mg/m2/bi-week 5-FU/infusional 2,400mg/m2/bi-week (day 1-3)) FOLFIRI+Cetuximab second line chemotherapy (1) mFOLFOX6+Bevacizumab (Bevacizumab 5mg/kg/bi-week L-OHP 85mg/m2/bi-week l-LV 200mg/m2/bi-week 5-FU/bolus 400mg/m2/bi-week 5-FU/infusional 2,400mg/m2/bi-week (day 1-3)) second line chemotherapy (2) XELOX+Bevacizumab (Bevacizumab 7.5mg/kg/tri-week L-OHP 130mg/m2/tri-week Capecitabine 2000mg/m2/day/2 (day 1-15)) Primary outcome(s): Total Progression free survival (PFS1+PFS2): PFS during first-line (PFS1) and PFS during second-line (PFS2) Study Design: Single arm Non-randomized

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Multicenter Phase II Study of FOLFOX/XELOX and Erbitux as First Line Therapy in Patients with Wild Type KRAS/BRAF Metastatic Colorectal Cancer.

Project description:Interventions: Cetuximab 500mg/m2/bi-week(day1) Oxaliplatin 85mg/m2/bi-week(day1) l-LV 200 mg/m2/bi-week(day1) 5-FU/bolus 400mg/m2/bi-week bolus(day1) 5-FU/infusional 2400mg/m2/bi-week(day1-3) Cetuximab 500mg/m2/bi-week(day1) Oxaliplatin 85mg/m2/bi-week(day1) Capecitabine 2000mg/m2/day1-7.bi-wekly Primary outcome(s): Response rate Study Design: Single arm Non-randomized

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A randomized phase III study of oxaliplatin based chemotherapy versus combination chemotherapy of TS-1,irinotecan and bevacizumab as first line therapy for unresectable or recurrent colorectal cancer

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